P10 - Statistical Analysis of Non-Neoplastic Lesions (Rats)
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus ESTRAGOLE DATE: 10/08/03
EXPERIMENT: 60946 TEST: 01 TIME: 09:15:40
TEST TYPE: SUBCHRON 90-DAY CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-15460 ROUTE: GAVAGE NTP C#: C60946
PATHOLOGIST: MISSING CAS: 140-67-0
------------------------------------------------------------------------------------------------------------------------------------
FINAL/RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus ESTRAGOLE DATE: 10/08/03
EXPERIMENT: 60946 TEST: 01 TIME: 09:15:40
TEST TYPE: SUBCHRON 90-DAY CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-15460 ROUTE: GAVAGE NTP C#: C60946
PATHOLOGIST: MISSING CAS: 140-67-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF ESTRAGOLE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Bone Marrow Hyperplasia
Epididymis Hypospermia
Epididymis: Bilateral Hypospermia
Kidney Infiltration Cellular Lymphocyte
Kidney: Cortex, Renal Tubule Pigmentation
Kidney: Papilla, Renal Tubule Mineralization
Liver Basophilic Focus
Cholangiofibrosis
Eosinophilic Focus
Mixed Cell Focus
Liver: Bile Duct Hyperplasia
Liver: Hepatocyte Hypertrophy
Liver: Oval Cell Hyperplasia
Liver: Periportal Infiltration Cellular Histiocyte
Inflammation Chronic
Lung Inflammation Granulomatous
Lymph Node, Mesenteric Hyperplasia Lymphoid
Nose: Olfactory Epithelium Degeneration
Pituitary Gland: Pars Distalis, Chromophobe Cell
Hypertrophy
Salivary Glands: Submandibular Gland Cytoplasmic Alteration
Stomach, Glandular: Epithelium, Glands
Atrophy
Testes: Bilateral, Germinal Epithelium
Degeneration
Testes: Germinal Epithelium Degeneration
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Kidney Infiltration Cellular Lymphocyte
Kidney: Papilla, Renal Tubule Mineralization
Kidney: Renal Tubule Regeneration
Liver Basophilic Focus
Eosinophilic Focus
Inflammation Chronic
Mixed Cell Focus
Liver: Bile Duct Hyperplasia
Liver: Hepatocyte Hypertrophy
Liver: Oval Cell Hyperplasia
Liver: Periportal Infiltration Cellular Histiocyte
Inflammation Chronic
Lung Inflammation Chronic
Lymph Node, Mesenteric Hyperplasia Lymphoid
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus ESTRAGOLE DATE: 10/08/03
EXPERIMENT: 60946 TEST: 01 TIME: 09:15:40
TEST TYPE: SUBCHRON 90-DAY CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-15460 ROUTE: GAVAGE NTP C#: C60946
PATHOLOGIST: MISSING CAS: 140-67-0
Nose: Olfactory Epithelium Degeneration
Salivary Glands: Submandibular Gland Cytoplasmic Alteration
Stomach, Glandular: Epithelium, Glands
Atrophy
===============================================================
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 4/10 (40%) 3/10 (30%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 4/10.00 3/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 40.0% 30.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 4/10 (40%) 3/10 (30%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.051 P=0.111 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.033 * P=0.095 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.033 * P=0.095 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.033 * P=0.095 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P=0.051 P=0.111 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.043 * P=0.105 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.309N P=1.000N P=1.000N P=1.000N P=1.000N P=0.500N |
|POLY 3 | (e) (e) (e) (e) (e) P=0.500N |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.500N |
|POLY 6 | (e) (e) (e) (e) (e) P=0.500N |
|LOGISTIC REGRESSION| P=0.309N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.304N P=1.000 P=1.000 P=1.000 P=1.000 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Epididymis |
| Hypospermia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 1/10.00 0/10.00 0/10.00 0/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | 93 (T) --- --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500N P=0.500N P=0.500N P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.500N P=0.500N P=0.500N P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.500N P=0.500N P=0.500N P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.500N P=0.500N P=0.500N P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.500N P=0.500N P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Epididymis |
| Hypospermia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Epididymis: Bilateral |
| Hypospermia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Epididymis: Bilateral |
| Hypospermia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) |
|POLY-3 RATE (b) | 2/10.00 0/0.00 0/0.00 0/0.00 0/0.00 3/10.00 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 0.0% 30.0% |
|TERMINAL (d) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.401 P=1.000N P=1.000N P=1.000N P=1.000N P=0.500 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.500 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.500 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.500 |
|LOGISTIC REGRESSION| P=0.401 (e) (e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.398 P=1.000 P=1.000 P=1.000 P=1.000 P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.309 (e) (e) (e) (e) P=0.500 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.500 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.500 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.500 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.304 (e) (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/10 (60%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) |
|POLY-3 RATE (b) | 6/10.00 0/0.00 0/0.00 0/0.00 0/0.00 3/10.00 |
|POLY-3 PERCENT (g) | 60.0% 0.0% 0.0% 0.0% 0.0% 30.0% |
|TERMINAL (d) | 6/10 (60%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.137N P=1.000N P=1.000N P=1.000N P=1.000N P=0.190N |
|POLY 3 | (e) (e) (e) (e) (e) P=0.186N |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.186N |
|POLY 6 | (e) (e) (e) (e) (e) P=0.186N |
|LOGISTIC REGRESSION| P=0.137N (e) (e) (e) (e) P=0.190N |
|COCH-ARM / FISHERS | P=0.131N P=1.000 P=1.000 P=1.000 P=1.000 P=0.185N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 2/10.00 0/0.00 0/0.00 0/0.00 0/0.00 2/10.00 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 0.0% 20.0% |
|TERMINAL (d) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.607 P=1.000N P=1.000N P=1.000N P=1.000N P=0.707 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.702 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.702 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.702 |
|LOGISTIC REGRESSION| P=0.607 (e) (e) (e) (e) P=0.707 |
|COCH-ARM / FISHERS | P=0.610 P=1.000 P=1.000 P=1.000 P=1.000 P=0.709N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 7/10 (70%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/10.00 0/10.00 1/10.00 2/10.00 7/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 10.0% 20.0% 70.0% 0.0% |
|TERMINAL (d) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 7/10 (70%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) --- 93 (T) 93 (T) 93 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.378 P=0.500N P=0.766 P=0.500 P=0.013 * P=0.500N |
|POLY 3 | P=0.352 P=0.500N P=0.760 P=0.500 P=0.003 ** P=0.500N |
|POLY 1.5 | P=0.352 P=0.500N P=0.760 P=0.500 P=0.003 ** P=0.500N |
|POLY 6 | P=0.352 P=0.500N P=0.760 P=0.500 P=0.003 ** P=0.500N |
|LOGISTIC REGRESSION| P=0.378 (e) P=0.766 P=0.500 P=0.013 * (e) |
|COCH-ARM / FISHERS | P=0.377 P=0.500N P=0.763N P=0.500 P=0.010 * P=0.500N |
|ORDER RESTRICTED | P=0.024 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 3/10 (30%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 1/10.00 3/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 10.0% 30.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 3/10 (30%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** (e) (e) (e) P=0.500 P=0.111 |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.500 P=0.095 |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.500 P=0.095 |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.500 P=0.095 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.500 P=0.111 |
|COCH-ARM / FISHERS | P=0.002 ** (e) (e) (e) P=0.500 P=0.105 |
|ORDER RESTRICTED | P=0.003 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Cortex, Renal Tubule |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Cortex, Renal Tubule |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 1/10 (10%) 4/10 (40%) 4/10 (40%) 1/10 (10%) 1/10 (10%) |
|POLY-3 RATE (b) | 2/10.00 1/10.00 4/10.00 4/10.00 1/10.00 1/10.00 |
|POLY-3 PERCENT (g) | 20.0% 10.0% 40.0% 40.0% 10.0% 10.0% |
|TERMINAL (d) | 2/10 (20%) 1/10 (10%) 4/10 (40%) 4/10 (40%) 1/10 (10%) 1/10 (10%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.211N P=0.500N P=0.317 P=0.317 P=0.500N P=0.500N |
|POLY 3 | P=0.209N P=0.500N P=0.318 P=0.318 P=0.500N P=0.500N |
|POLY 1.5 | P=0.209N P=0.500N P=0.318 P=0.318 P=0.500N P=0.500N |
|POLY 6 | P=0.209N P=0.500N P=0.318 P=0.318 P=0.500N P=0.500N |
|LOGISTIC REGRESSION| P=0.211N P=0.500N P=0.317 P=0.317 P=0.500N P=0.500N |
|COCH-ARM / FISHERS | P=0.209N P=0.500N P=0.314 P=0.314 P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.304N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Cortex, Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P=0.831 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Cortex, Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Papilla, Renal Tubule |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/10 (40%) 2/10 (20%) 2/10 (20%) 8/10 (80%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 4/10.00 2/10.00 2/10.00 8/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 40.0% 20.0% 20.0% 80.0% 100.0% 100.0% |
|TERMINAL (d) | 4/10 (40%) 2/10 (20%) 2/10 (20%) 8/10 (80%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.317N P=0.317N P=0.091 P=0.009 ** P=0.009 ** |
|POLY 3 | P<0.001 ** P=0.318N P=0.318N P=0.077 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.318N P=0.318N P=0.077 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.318N P=0.318N P=0.077 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.317N P=0.317N P=0.091 P=0.009 ** P=0.009 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.314N P=0.314N P=0.085 P=0.005 ** P=0.005 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Papilla, Renal Tubule |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 4/10 (40%) 6/10 (60%) 7/10 (70%) 9/10 (90%) 7/10 (70%) |
|POLY-3 RATE (b) | 3/10.00 4/10.00 6/10.00 7/10.00 9/10.00 7/10.00 |
|POLY-3 PERCENT (g) | 30.0% 40.0% 60.0% 70.0% 90.0% 70.0% |
|TERMINAL (d) | 3/10 (30%) 4/10 (40%) 6/10 (60%) 7/10 (70%) 9/10 (90%) 7/10 (70%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.035 * P=0.500 P=0.190 P=0.095 P=0.013 * P=0.095 |
|POLY 3 | P=0.029 * P=0.500 P=0.186 P=0.082 P=0.003 ** P=0.082 |
|POLY 1.5 | P=0.029 * P=0.500 P=0.186 P=0.082 P=0.003 ** P=0.082 |
|POLY 6 | P=0.029 * P=0.500 P=0.186 P=0.082 P=0.003 ** P=0.082 |
|LOGISTIC REGRESSION| P=0.035 * P=0.500 P=0.190 P=0.095 P=0.013 * P=0.095 |
|COCH-ARM / FISHERS | P=0.034 * P=0.500 P=0.185 P=0.089 P=0.010 * P=0.089 |
|ORDER RESTRICTED | P=0.011 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Regeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/10 (70%) 7/10 (70%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 8/10 (80%) |
|POLY-3 RATE (b) | 7/10.00 7/10.00 10/10.00 10/10.00 10/10.00 8/10.00 |
|POLY-3 PERCENT (g) | 70.0% 70.0% 100.0% 100.0% 100.0% 80.0% |
|TERMINAL (d) | 7/10 (70%) 7/10 (70%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 8/10 (80%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.436 P=0.683 P=0.111 P=0.111 P=0.111 P=0.500 |
|POLY 3 | P=0.434 P=0.678 P=0.095 P=0.095 P=0.095 P=0.500 |
|POLY 1.5 | P=0.434 P=0.678 P=0.095 P=0.095 P=0.095 P=0.500 |
|POLY 6 | P=0.434 P=0.678 P=0.095 P=0.095 P=0.095 P=0.500 |
|LOGISTIC REGRESSION| P=0.436 P=0.683 P=0.111 P=0.111 P=0.111 P=0.500 |
|COCH-ARM / FISHERS | P=0.436 P=0.686N P=0.105 P=0.105 P=0.105 P=0.500 |
|ORDER RESTRICTED | P=0.068 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Regeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 2/10 (20%) 1/10 (10%) 1/10 (10%) 3/10 (30%) 6/10 (60%) |
|POLY-3 RATE (b) | 1/10.00 2/10.00 1/10.00 1/10.00 3/10.00 6/10.00 |
|POLY-3 PERCENT (g) | 10.0% 20.0% 10.0% 10.0% 30.0% 60.0% |
|TERMINAL (d) | 1/10 (10%) 2/10 (20%) 1/10 (10%) 1/10 (10%) 3/10 (30%) 6/10 (60%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.500 P=0.766 P=0.766 P=0.293 P=0.034 * |
|POLY 3 | P<0.001 ** P=0.500 P=0.760 P=0.760 P=0.292 P=0.018 * |
|POLY 1.5 | P<0.001 ** P=0.500 P=0.760 P=0.760 P=0.292 P=0.018 * |
|POLY 6 | P<0.001 ** P=0.500 P=0.760 P=0.760 P=0.292 P=0.018 * |
|LOGISTIC REGRESSION| P=0.002 ** P=0.500 P=0.766 P=0.766 P=0.293 P=0.034 * |
|COCH-ARM / FISHERS | P=0.002 ** P=0.500 P=0.763N P=0.763N P=0.291 P=0.029 * |
|ORDER RESTRICTED | P=0.004 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 2/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 20.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.414 (e) (e) (e) P=0.234 (e) |
|POLY 3 | P=0.410 (e) (e) (e) P=0.227 (e) |
|POLY 1.5 | P=0.410 (e) (e) (e) P=0.227 (e) |
|POLY 6 | P=0.410 (e) (e) (e) P=0.227 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.234 (e) |
|COCH-ARM / FISHERS | P=0.414 (e) (e) (e) P=0.237 (e) |
|ORDER RESTRICTED | P=0.165 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 6/10 (60%) 9/10 (90%) 6/10 (60%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 6/10.00 9/10.00 6/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 60.0% 90.0% 60.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 6/10 (60%) 9/10 (90%) 6/10 (60%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.009 ** P<0.001 ** P=0.009 ** |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.009 ** P<0.001 ** P=0.009 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.005 ** P<0.001 ** P=0.005 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 3/10 (30%) 6/10 (60%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 3/10.00 6/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 30.0% 60.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 3/10 (30%) 6/10 (60%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.111 P=0.009 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.095 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.095 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.095 P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P=0.111 P=0.009 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.105 P=0.005 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Cholangiofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Cholangiofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 3 | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 1.5 | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 6 | P=0.107 (e) (e) (e) (e) P=0.500 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.105 (e) (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.064 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 1/10 (10%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 3/10.00 1/10.00 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 30.0% 10.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 1/10 (10%) 1/10 (10%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.301 (e) (e) P=0.111 P=0.500 P=0.500 |
|POLY 3 | P=0.295 (e) (e) P=0.095 P=0.500 P=0.500 |
|POLY 1.5 | P=0.295 (e) (e) P=0.095 P=0.500 P=0.500 |
|POLY 6 | P=0.295 (e) (e) P=0.095 P=0.500 P=0.500 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.111 P=0.500 P=0.500 |
|COCH-ARM / FISHERS | P=0.300 (e) (e) P=0.105 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.138 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 3 | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 1.5 | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 6 | P=0.107 (e) (e) (e) (e) P=0.500 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.105 (e) (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.064 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 1/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 10.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.500 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.500 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.500 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.500 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.500 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.500 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 3/10 (30%) 0/10 (0%) 1/10 (10%) 3/10 (30%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/10.00 3/10.00 0/10.00 1/10.00 3/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 10.0% 30.0% 0.0% 10.0% 30.0% 0.0% |
|TERMINAL (d) | 1/10 (10%) 3/10 (30%) 0/10 (0%) 1/10 (10%) 3/10 (30%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) 93 (T) --- 93 (T) 93 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.332N P=0.293 P=0.500N P=0.766 P=0.293 P=0.500N |
|POLY 3 | P=0.328N P=0.292 P=0.500N P=0.760 P=0.292 P=0.500N |
|POLY 1.5 | P=0.328N P=0.292 P=0.500N P=0.760 P=0.292 P=0.500N |
|POLY 6 | P=0.328N P=0.292 P=0.500N P=0.760 P=0.292 P=0.500N |
|LOGISTIC REGRESSION| P=0.332N P=0.293 (e) P=0.766 P=0.293 (e) |
|COCH-ARM / FISHERS | P=0.331N P=0.291 P=0.500N P=0.763N P=0.291 P=0.500N |
|ORDER RESTRICTED | P=0.151N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 2/10 (20%) 2/10 (20%) 1/10 (10%) 2/10 (20%) 0/10 (0%) |
|POLY-3 RATE (b) | 2/10.00 2/10.00 2/10.00 1/10.00 2/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 20.0% 20.0% 20.0% 10.0% 20.0% 0.0% |
|TERMINAL (d) | 2/10 (20%) 2/10 (20%) 2/10 (20%) 1/10 (10%) 2/10 (20%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.141N P=0.707 P=0.707 P=0.500N P=0.707 P=0.234N |
|POLY 3 | P=0.146N P=0.702 P=0.702 P=0.500N P=0.702 P=0.227N |
|POLY 1.5 | P=0.146N P=0.702 P=0.702 P=0.500N P=0.702 P=0.227N |
|POLY 6 | P=0.146N P=0.702 P=0.702 P=0.500N P=0.702 P=0.227N |
|LOGISTIC REGRESSION| P=0.141N P=0.707 P=0.707 P=0.500N P=0.707 (e) |
|COCH-ARM / FISHERS | P=0.139N P=0.709N P=0.709N P=0.500N P=0.709N P=0.237N |
|ORDER RESTRICTED | P=0.193N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 2/10 (20%) 1/10 (10%) 1/10 (10%) 3/10 (30%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/10.00 2/10.00 1/10.00 1/10.00 3/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 10.0% 20.0% 10.0% 10.0% 30.0% 0.0% |
|TERMINAL (d) | 1/10 (10%) 2/10 (20%) 1/10 (10%) 1/10 (10%) 3/10 (30%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.357N P=0.500 P=0.766 P=0.766 P=0.293 P=0.500N |
|POLY 3 | P=0.358N P=0.500 P=0.760 P=0.760 P=0.292 P=0.500N |
|POLY 1.5 | P=0.358N P=0.500 P=0.760 P=0.760 P=0.292 P=0.500N |
|POLY 6 | P=0.358N P=0.500 P=0.760 P=0.760 P=0.292 P=0.500N |
|LOGISTIC REGRESSION| P=0.357N P=0.500 P=0.766 P=0.766 P=0.293 (e) |
|COCH-ARM / FISHERS | P=0.356N P=0.500 P=0.763N P=0.763N P=0.291 P=0.500N |
|ORDER RESTRICTED | P=0.265N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/10 (40%) 4/10 (40%) 5/10 (50%) 6/10 (60%) 3/10 (30%) 0/10 (0%) |
|POLY-3 RATE (b) | 4/10.00 4/10.00 5/10.00 6/10.00 3/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 40.0% 40.0% 50.0% 60.0% 30.0% 0.0% |
|TERMINAL (d) | 4/10 (40%) 4/10 (40%) 5/10 (50%) 6/10 (60%) 3/10 (30%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011N* P=0.672 P=0.500 P=0.331 P=0.500N P=0.051N |
|POLY 3 | P=0.008N** P=0.667 P=0.500 P=0.333 P=0.500N P=0.033N* |
|POLY 1.5 | P=0.008N** P=0.667 P=0.500 P=0.333 P=0.500N P=0.033N* |
|POLY 6 | P=0.008N** P=0.667 P=0.500 P=0.333 P=0.500N P=0.033N* |
|LOGISTIC REGRESSION| P=0.011N* P=0.672 P=0.500 P=0.331 P=0.500N (e) |
|COCH-ARM / FISHERS | P=0.010N* P=0.675N P=0.500 P=0.328 P=0.500N P=0.043N* |
|ORDER RESTRICTED | P=0.014N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 9/10 (90%) 10/10 (100%) 8/10 (80%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 1/10.00 9/10.00 10/10.00 8/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.0% 90.0% 100.0% 80.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 9/10 (90%) 10/10 (100%) 8/10 (80%) |
|FIRST INCIDENCE | --- --- 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 6/10 (60%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 1/10.00 6/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.0% 60.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 6/10 (60%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.500 P=0.009 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P=0.500 P=0.009 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 P=0.005 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P=0.831 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Oval Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Oval Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Periportal |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001N** P<0.001N** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001N** P<0.001N** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001N** P<0.001N** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Periportal |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001N** (e) (e) P<0.001 ** P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** (e) (e) P<0.001 ** P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** (e) (e) P<0.001 ** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P=0.831 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Periportal |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001N** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001N** |
|POLY 1.5 | P<0.001N** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001N** |
|POLY 6 | P<0.001N** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001N** |
|LOGISTIC REGRESSION| (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Periportal |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 5/10 (50%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 5/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 50.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 5/10 (50%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.022 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** P<0.001N** P<0.001N** |
|POLY 6 | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| (e) P=0.022 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 3/10 (30%) 6/10 (60%) 7/10 (70%) 6/10 (60%) 8/10 (80%) |
|POLY-3 RATE (b) | 5/10.00 3/10.00 6/10.00 7/10.00 6/10.00 8/10.00 |
|POLY-3 PERCENT (g) | 50.0% 30.0% 60.0% 70.0% 60.0% 80.0% |
|TERMINAL (d) | 5/10 (50%) 3/10 (30%) 6/10 (60%) 7/10 (70%) 6/10 (60%) 8/10 (80%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.053 P=0.328N P=0.500 P=0.328 P=0.500 P=0.180 |
|POLY 3 | P=0.051 P=0.329N P=0.500 P=0.329 P=0.500 P=0.174 |
|POLY 1.5 | P=0.051 P=0.329N P=0.500 P=0.329 P=0.500 P=0.174 |
|POLY 6 | P=0.051 P=0.329N P=0.500 P=0.329 P=0.500 P=0.174 |
|LOGISTIC REGRESSION| P=0.053 P=0.328N P=0.500 P=0.328 P=0.500 P=0.180 |
|COCH-ARM / FISHERS | P=0.052 P=0.325N P=0.500 P=0.325 P=0.500 P=0.175 |
|ORDER RESTRICTED | P=0.051 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 6/10 (60%) 3/10 (30%) 4/10 (40%) 8/10 (80%) 10/10 (100%) |
|POLY-3 RATE (b) | 5/10.00 6/10.00 3/10.00 4/10.00 8/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 50.0% 60.0% 30.0% 40.0% 80.0% 100.0% |
|TERMINAL (d) | 5/10 (50%) 6/10 (60%) 3/10 (30%) 4/10 (40%) 8/10 (80%) 10/10 (100%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.500 P=0.328N P=0.500N P=0.180 P=0.022 * |
|POLY 3 | P<0.001 ** P=0.500 P=0.329N P=0.500N P=0.174 P=0.008 ** |
|POLY 1.5 | P<0.001 ** P=0.500 P=0.329N P=0.500N P=0.174 P=0.008 ** |
|POLY 6 | P<0.001 ** P=0.500 P=0.329N P=0.500N P=0.174 P=0.008 ** |
|LOGISTIC REGRESSION| P=0.002 ** P=0.500 P=0.328N P=0.500N P=0.180 P=0.022 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.325N P=0.500N P=0.175 P=0.016 * |
|ORDER RESTRICTED | P=0.005 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 4/10 (40%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 1/10.00 0/10.00 0/10.00 4/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 10.0% 0.0% 0.0% 40.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 4/10 (40%) 0/10 (0%) |
|FIRST INCIDENCE | --- 93 (T) --- --- 93 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.395 P=0.500 (e) (e) P=0.051 (e) |
|POLY 3 | P=0.382 P=0.500 (e) (e) P=0.033 * (e) |
|POLY 1.5 | P=0.382 P=0.500 (e) (e) P=0.033 * (e) |
|POLY 6 | P=0.382 P=0.500 (e) (e) P=0.033 * (e) |
|LOGISTIC REGRESSION| (e) P=0.500 (e) (e) P=0.051 (e) |
|COCH-ARM / FISHERS | P=0.394 P=0.500 (e) (e) P=0.043 * (e) |
|ORDER RESTRICTED | P=0.052 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 2/7 (29%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 1/10.00 0/10.00 0/10.00 2/7.00 2/10.00 |
|POLY-3 PERCENT (g) | 0.0% 10.0% 0.0% 0.0% 28.6% 20.0% |
|TERMINAL (d) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 2/7 (29%) 2/10 (20%) |
|FIRST INCIDENCE | --- 93 (T) --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.049 * P=0.500 (e) (e) P=0.158 P=0.234 |
|POLY 3 | P=0.045 * P=0.500 (e) (e) P=0.140 P=0.227 |
|POLY 1.5 | P=0.045 * P=0.500 (e) (e) P=0.140 P=0.227 |
|POLY 6 | P=0.045 * P=0.500 (e) (e) P=0.140 P=0.227 |
|LOGISTIC REGRESSION| (e) P=0.500 (e) (e) P=0.158 P=0.234 |
|COCH-ARM / FISHERS | P=0.048 * P=0.500 (e) (e) P=0.154 P=0.237 |
|ORDER RESTRICTED | P=0.039 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 3/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 30.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.111 |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.095 |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.095 |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.095 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.111 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.105 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/3 (67%) 3/3 (100%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 0/0.00 0/0.00 2/3.00 3/3.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 66.7% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/3 (67%) 3/3 (100%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.500 (e) (e) (e) P=1.000N (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=1.000N (e) |
|COCH-ARM / FISHERS | P=0.500 (e) (e) (e) P=1.000 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/4 (100%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 0/0.00 0/0.00 0/0.00 4/4.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/4 (100%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/3 (100%) 3/3 (100%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 0/0.00 0/0.00 3/3.00 3/3.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/3 (100%) 3/3 (100%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/4 (100%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 0/0.00 0/0.00 0/0.00 4/4.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/4 (100%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 2/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 20.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- 93 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.586N (e) (e) P=0.234 (e) (e) |
|POLY 3 | P=0.590N (e) (e) P=0.227 (e) (e) |
|POLY 1.5 | P=0.590N (e) (e) P=0.227 (e) (e) |
|POLY 6 | P=0.590N (e) (e) P=0.227 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.234 (e) (e) |
|COCH-ARM / FISHERS | P=0.586N (e) (e) P=0.237 (e) (e) |
|ORDER RESTRICTED | P=0.348 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 9/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 90.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 1/10.00 2/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.0% 20.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.500 P=0.234 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.500 P=0.227 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.500 P=0.227 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.500 P=0.227 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P=0.500 P=0.234 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 P=0.237 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis, Chromophobe Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis, Chromophobe Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Salivary Glands: Submandibular Gland |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Salivary Glands: Submandibular Gland |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 1/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 10.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- 93 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.697N (e) (e) P=0.500 (e) (e) |
|POLY 3 | P=0.697N (e) (e) P=0.500 (e) (e) |
|POLY 1.5 | P=0.697N (e) (e) P=0.500 (e) (e) |
|POLY 6 | P=0.697N (e) (e) P=0.500 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.500 (e) (e) |
|COCH-ARM / FISHERS | P=0.699N (e) (e) P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.513 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 1/10.00 2/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 10.0% 20.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.479 (e) (e) P=0.500 P=0.234 (e) |
|POLY 3 | P=0.478 (e) (e) P=0.500 P=0.227 (e) |
|POLY 1.5 | P=0.478 (e) (e) P=0.500 P=0.227 (e) |
|POLY 6 | P=0.478 (e) (e) P=0.500 P=0.227 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.500 P=0.234 (e) |
|COCH-ARM / FISHERS | P=0.478 (e) (e) P=0.500 P=0.237 (e) |
|ORDER RESTRICTED | P=0.265 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular: Epithelium, Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 2/10 (20%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 2/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 20.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 2/10 (20%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.234 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.227 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.227 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.227 P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P=0.234 P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.237 P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular: Epithelium, Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 8/10 (80%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 8/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 80.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 8/10 (80%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Testes: Bilateral, Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Testes: Bilateral, Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 1/10.00 0/10.00 0/10.00 2/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 20.0% 100.0% 100.0% |
|TERMINAL (d) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | 93 (T) --- --- 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500N P=0.500N P=0.500 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.500N P=0.500N P=0.500 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.500N P=0.500N P=0.500 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.500N P=0.500N P=0.500 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.500 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.500N P=0.500 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 3/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 30.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.064N P=1.000N P=1.000N P=1.000N P=1.000N P=0.111N |
|POLY 3 | (e) (e) (e) (e) (e) P=0.095N |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.095N |
|POLY 6 | (e) (e) (e) (e) (e) P=0.095N |
|LOGISTIC REGRESSION| P=0.064N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.059N P=1.000 P=1.000 P=1.000 P=1.000 P=0.105N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).