TDMS Study 05161-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst RIDDELLIINE DATE: 12/12/00
EXPERIMENT: 05161 TEST: 06 TIME: 09:44:23
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55393 ROUTE: GAVAGE NTP C#: 61358C
PATHOLOGIST: FARNELL, D. CAS: 23246-96-0
------------------------------------------------------------------------------------------------------------------------------------
MALE MICE/FINAL#1
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 MG/KG/DY
INCLUDE 003 0.1 MG/KG/DY
INCLUDE 004 0.3 MG/KG/DY
INCLUDE 005 1.0 MG/KG/DY
INCLUDE 006 3.0 MG/KG/DY
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst RIDDELLIINE DATE: 12/12/00
EXPERIMENT: 05161 TEST: 06 TIME: 09:44:23
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: GAVAGE NTP C#: 61358C
PATHOLOGIST: FARNELL, D. CAS: 23246-96-0
Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Bone Marrow
Clitoral/Preputial Gland
Epididymis
Islets, Pancreatic
Kidney
Liver
Lung
Pancreas
Pituitary Gland
Spleen
Testes
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst RIDDELLIINE DATE: 12/12/00
EXPERIMENT: 05161 TEST: 06 TIME: 09:44:23
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: GAVAGE NTP C#: 61358C
PATHOLOGIST: FARNELL, D. CAS: 23246-96-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF RIDDELLIINE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Liver Hemangiosarcoma
Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Testes Adenoma
All Organs Hemangiosarcoma
Histiocytic Sarcoma
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 7/49 (14%) 4/50 (8%) 3/50 (6%) 2/49 (4%) |
|POLY-3 RATE (b) | 3/44.94 7/45.16 4/47.70 3/45.55 2/39.41 |
|POLY-3 PERCENT (g) | 6.7% 15.5% 8.4% 6.6% 5.1% |
|TERMINAL (d) | 3/39 (8%) 7/40 (18%) 4/40 (10%) 2/38 (5%) 1/20 (5%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 707 660 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.452N P=0.167 P=0.514 P=0.650 P=0.604 |
|POLY 3 | P=0.207N P=0.159 P=0.532 P=0.656N P=0.560N |
|POLY 1.5 | P=0.180N P=0.161 P=0.528 P=0.651N P=0.529N |
|POLY 6 | P=0.251N P=0.155 P=0.535 P=0.661 P=0.607N |
|LOGISTIC REGRESSION| P=0.317N P=0.167 P=0.514 P=0.655 P=0.633N |
|COCH-ARM / FISHERS | P=0.152N P=0.159 P=0.511 P=0.651N P=0.500N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 6/50 (12%) 8/50 (16%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/45.50 1/46.29 6/48.10 8/46.47 2/39.65 |
|POLY-3 PERCENT (g) | 8.8% 2.2% 12.5% 17.2% 5.0% |
|TERMINAL (d) | 4/39 (10%) 0/41 (0%) 5/40 (13%) 4/38 (11%) 2/20 (10%) |
|FIRST INCIDENCE | 729 (T) 696 614 554 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.421 P=0.170N P=0.388 P=0.177 P=0.663N |
|POLY 3 | P=0.510N P=0.173N P=0.405 P=0.187 P=0.402N |
|POLY 1.5 | P=0.445N P=0.174N P=0.395 P=0.186 P=0.369N |
|POLY 6 | P=0.534 P=0.173N P=0.414 P=0.187 P=0.459N |
|LOGISTIC REGRESSION| P=0.444N P=0.175N P=0.395 P=0.179 P=0.663N |
|COCH-ARM / FISHERS | P=0.373N P=0.181N P=0.370 P=0.178 P=0.339N |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/45.56 0/46.16 1/47.70 1/45.46 1/39.93 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 2.1% 2.2% 2.5% |
|TERMINAL (d) | 1/39 (3%) 0/41 (0%) 1/40 (3%) 1/38 (3%) 0/20 (0%) |
|FIRST INCIDENCE | 713 --- 729 (T) 729 (T) 652 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.509 P=0.234N P=0.486N P=0.512N P=0.673N |
|POLY 3 | P=0.618 P=0.234N P=0.484N P=0.501N P=0.546N |
|POLY 1.5 | P=0.642 P=0.234N P=0.488N P=0.498N P=0.522N |
|POLY 6 | P=0.581 P=0.235N P=0.481N P=0.506N P=0.583N |
|LOGISTIC REGRESSION| P=0.638 P=0.235N P=0.480N P=0.507N P=0.535N |
|COCH-ARM / FISHERS | P=0.642N P=0.247N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 6/50 (12%) 1/50 (2%) 7/50 (14%) 8/50 (16%) 3/50 (6%) |
|POLY-3 RATE (b) | 6/45.56 1/46.29 7/48.10 8/46.47 3/39.93 |
|POLY-3 PERCENT (g) | 13.2% 2.2% 14.6% 17.2% 7.5% |
|TERMINAL (d) | 5/39 (13%) 0/41 (0%) 6/40 (15%) 4/38 (11%) 2/20 (10%) |
|FIRST INCIDENCE | 713 696 614 554 652 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.377 P=0.056N P=0.524 P=0.375 P=0.598N |
|POLY 3 | P=0.499N P=0.053N P=0.542 P=0.402 P=0.311N |
|POLY 1.5 | P=0.437N P=0.054N P=0.530 P=0.400 P=0.275N |
|POLY 6 | P=0.541 P=0.053N P=0.552 P=0.402 P=0.374N |
|LOGISTIC REGRESSION| P=0.441N P=0.056N P=0.535 P=0.389 P=0.433N |
|COCH-ARM / FISHERS | P=0.367N P=0.056N P=0.500 P=0.387 P=0.243N |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.50 0/46.16 1/47.70 2/45.46 0/39.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.1% 4.4% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/41 (0%) 1/40 (3%) 2/38 (5%) 0/20 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.654 (e) P=0.505 P=0.233 (e) |
|POLY 3 | P=0.689N (e) P=0.509 P=0.237 (e) |
|POLY 1.5 | P=0.663N (e) P=0.507 P=0.239 (e) |
|POLY 6 | P=0.628 (e) P=0.511 P=0.234 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.505 P=0.233 (e) |
|COCH-ARM / FISHERS | P=0.634N (e) P=0.500 P=0.247 (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.50 0/46.16 1/47.70 2/45.46 0/39.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.1% 4.4% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/41 (0%) 1/40 (3%) 2/38 (5%) 0/20 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.654 (e) P=0.505 P=0.233 (e) |
|POLY 3 | P=0.689N (e) P=0.509 P=0.237 (e) |
|POLY 1.5 | P=0.663N (e) P=0.507 P=0.239 (e) |
|POLY 6 | P=0.628 (e) P=0.511 P=0.234 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.505 P=0.233 (e) |
|COCH-ARM / FISHERS | P=0.634N (e) P=0.500 P=0.247 (e) |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 3/45.55 0/46.16 0/47.70 0/45.46 0/38.29 |
|POLY-3 PERCENT (g) | 6.6% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/39 (5%) 0/41 (0%) 0/40 (0%) 0/38 (0%) 0/20 (0%) |
|FIRST INCIDENCE | 637 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.260N P=0.119N P=0.118N P=0.126N P=0.227N |
|POLY 3 | P=0.202N P=0.116N P=0.111N P=0.119N P=0.153N |
|POLY 1.5 | P=0.202N P=0.115N P=0.111N P=0.116N P=0.137N |
|POLY 6 | P=0.200N P=0.118N P=0.111N P=0.123N P=0.180N |
|LOGISTIC REGRESSION| P=0.195N P=0.117N P=0.120N P=0.117N P=0.131N |
|COCH-ARM / FISHERS | P=0.200N P=0.117N P=0.117N P=0.117N P=0.125N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 31/50 (62%) |
|POLY-3 RATE (b) | 2/45.50 1/46.16 0/47.70 2/45.46 31/46.49 |
|POLY-3 PERCENT (g) | 4.4% 2.2% 0.0% 4.4% 66.7% |
|TERMINAL (d) | 2/39 (5%) 1/41 (2%) 0/40 (0%) 2/38 (5%) 8/20 (40%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) 550 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.483N P=0.233N P=0.686 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.495N P=0.227N P=0.694 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.495N P=0.230N P=0.691N P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.496N P=0.225N P=0.689 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.483N (e) P=0.686 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.247N P=0.691N P<0.001 ** |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/45.59 2/46.16 0/47.70 1/46.02 0/39.65 |
|POLY-3 PERCENT (g) | 6.6% 4.3% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 2/39 (5%) 2/41 (5%) 0/40 (0%) 0/38 (0%) 0/20 (0%) |
|FIRST INCIDENCE | 706 729 (T) --- 552 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.206N P=0.484N P=0.117N P=0.315N P=0.258N |
|POLY 3 | P=0.151N P=0.494N P=0.111N P=0.302N P=0.146N |
|POLY 1.5 | P=0.140N P=0.494N P=0.113N P=0.301N P=0.131N |
|POLY 6 | P=0.165N P=0.496N P=0.110N P=0.305N P=0.172N |
|LOGISTIC REGRESSION| P=0.121N P=0.495N P=0.111N P=0.314N P=0.192N |
|COCH-ARM / FISHERS | P=0.127N P=0.500N P=0.121N P=0.309N P=0.121N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 16/50 (32%) 18/50 (36%) 14/50 (28%) 5/50 (10%) 0/50 (0%) |
|POLY-3 RATE (b) | 16/46.83 18/46.34 14/48.23 5/45.99 0/39.65 |
|POLY-3 PERCENT (g) | 34.2% 38.8% 29.0% 10.9% 0.0% |
|TERMINAL (d) | 13/39 (33%) 17/41 (42%) 13/40 (33%) 4/38 (11%) 0/20 (0%) |
|FIRST INCIDENCE | 475 681 567 566 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** P=0.481 P=0.378N P=0.010N* P<0.001N** |
|POLY 3 | P<0.001N** P=0.400 P=0.375N P=0.006N** P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.414 P=0.383N P=0.006N** P<0.001N** |
|POLY 6 | P<0.001N** P=0.383 P=0.372N P=0.007N** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.435 P=0.399N P=0.007N** P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.417 P=0.414N P=0.006N** P<0.001N** |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 23/50 (46%) 21/50 (42%) 19/50 (38%) 20/50 (40%) 3/50 (6%) |
|POLY-3 RATE (b) | 23/48.23 21/48.57 19/49.44 20/46.73 3/40.12 |
|POLY-3 PERCENT (g) | 47.7% 43.2% 38.4% 42.8% 7.5% |
|TERMINAL (d) | 15/39 (39%) 15/41 (37%) 11/40 (28%) 16/38 (42%) 2/20 (10%) |
|FIRST INCIDENCE | 486 542 592 566 590 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004N** P=0.378N P=0.257N P=0.393N P=0.003N** |
|POLY 3 | P<0.001N** P=0.407N P=0.237N P=0.393N P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.403N P=0.242N P=0.361N P<0.001N** |
|POLY 6 | P<0.001N** P=0.417N P=0.236N P=0.439N P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.436N P=0.316N P=0.340N P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.420N P=0.272N P=0.343N P<0.001N** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 24/50 (48%) 22/50 (44%) 19/50 (38%) 21/50 (42%) 3/50 (6%) |
|POLY-3 RATE (b) | 24/48.23 22/48.57 19/49.44 21/47.29 3/40.12 |
|POLY-3 PERCENT (g) | 49.8% 45.3% 38.4% 44.4% 7.5% |
|TERMINAL (d) | 16/39 (41%) 16/41 (39%) 11/40 (28%) 16/38 (42%) 2/20 (10%) |
|FIRST INCIDENCE | 486 542 592 552 590 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003N** P=0.375N P=0.205N P=0.396N P=0.002N** |
|POLY 3 | P<0.001N** P=0.407N P=0.178N P=0.375N P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.402N P=0.183N P=0.351N P<0.001N** |
|POLY 6 | P<0.001N** P=0.417N P=0.177N P=0.412N P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.434N P=0.245N P=0.344N P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.421N P=0.210N P=0.344N P<0.001N** |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 36/50 (72%) 39/50 (78%) 33/50 (66%) 23/50 (46%) 3/50 (6%) |
|POLY-3 RATE (b) | 36/49.02 39/48.76 33/49.97 23/46.73 3/40.12 |
|POLY-3 PERCENT (g) | 73.4% 80.0% 66.0% 49.2% 7.5% |
|TERMINAL (d) | 26/39 (67%) 32/41 (78%) 24/40 (60%) 19/38 (50%) 2/20 (10%) |
|FIRST INCIDENCE | 475 542 567 566 590 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** P=0.465 P=0.302N P=0.024N* P<0.001N** |
|POLY 3 | P<0.001N** P=0.299 P=0.281N P=0.011N* P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.322 P=0.287N P=0.007N** P<0.001N** |
|POLY 6 | P<0.001N** P=0.273 P=0.282N P=0.018N* P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.338 P=0.356N P=0.007N** P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.322 P=0.333N P=0.007N** P<0.001N** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 36/50 (72%) 40/50 (80%) 33/50 (66%) 24/50 (48%) 3/50 (6%) |
|POLY-3 RATE (b) | 36/49.02 40/48.76 33/49.97 24/47.29 3/40.12 |
|POLY-3 PERCENT (g) | 73.4% 82.0% 66.0% 50.8% 7.5% |
|TERMINAL (d) | 26/39 (67%) 33/41 (81%) 24/40 (60%) 19/38 (50%) 2/20 (10%) |
|FIRST INCIDENCE | 475 542 567 552 590 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** P=0.398 P=0.302N P=0.038N* P<0.001N** |
|POLY 3 | P<0.001N** P=0.218 P=0.281N P=0.016N* P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.238 P=0.287N P=0.012N* P<0.001N** |
|POLY 6 | P<0.001N** P=0.195 P=0.282N P=0.024N* P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.257 P=0.356N P=0.012N* P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.241 P=0.333N P=0.012N* P<0.001N** |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 12/50 (24%) 10/50 (20%) 11/50 (22%) 8/50 (16%) 12/50 (24%) |
|POLY-3 RATE (b) | 12/45.59 10/46.16 11/47.70 8/45.70 12/42.14 |
|POLY-3 PERCENT (g) | 26.3% 21.7% 23.1% 17.5% 28.5% |
|TERMINAL (d) | 11/39 (28%) 10/41 (24%) 11/40 (28%) 6/38 (16%) 5/20 (25%) |
|FIRST INCIDENCE | 706 729 (T) 729 (T) 689 559 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.024 * P=0.355N P=0.471N P=0.250N P=0.114 |
|POLY 3 | P=0.356 P=0.391N P=0.450N P=0.222N P=0.505 |
|POLY 1.5 | P=0.405 P=0.391N P=0.463N P=0.219N P=0.553 |
|POLY 6 | P=0.288 P=0.395N P=0.442N P=0.228N P=0.426 |
|LOGISTIC REGRESSION| P=0.244 P=0.386N P=0.428N P=0.240N P=0.489 |
|COCH-ARM / FISHERS | P=0.464 P=0.405N P=0.500N P=0.227N P=0.592N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 8/50 (16%) 6/50 (12%) 1/50 (2%) 5/50 (10%) |
|POLY-3 RATE (b) | 7/46.01 8/46.16 6/48.26 1/45.46 5/40.38 |
|POLY-3 PERCENT (g) | 15.2% 17.3% 12.4% 2.2% 12.4% |
|TERMINAL (d) | 5/39 (13%) 8/41 (20%) 4/40 (10%) 1/38 (3%) 3/20 (15%) |
|FIRST INCIDENCE | 599 729 (T) 567 729 (T) 587 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.538 P=0.535 P=0.471N P=0.039N* P=0.483 |
|POLY 3 | P=0.289N P=0.503 P=0.463N P=0.031N* P=0.473N |
|POLY 1.5 | P=0.258N P=0.507 P=0.473N P=0.030N* P=0.425N |
|POLY 6 | P=0.335N P=0.495 P=0.457N P=0.033N* P=0.552N |
|LOGISTIC REGRESSION| P=0.296N P=0.511 P=0.504N P=0.032N* P=0.454N |
|COCH-ARM / FISHERS | P=0.224N P=0.500 P=0.500N P=0.030N* P=0.380N |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 18/50 (36%) 16/50 (32%) 15/50 (30%) 9/50 (18%) 17/50 (34%) |
|POLY-3 RATE (b) | 18/46.10 16/46.16 15/48.26 9/45.70 17/42.87 |
|POLY-3 PERCENT (g) | 39.1% 34.7% 31.1% 19.7% 39.7% |
|TERMINAL (d) | 15/39 (39%) 16/41 (39%) 13/40 (33%) 7/38 (18%) 8/20 (40%) |
|FIRST INCIDENCE | 599 729 (T) 567 689 559 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.016 * P=0.355N P=0.301N P=0.048N* P=0.079 |
|POLY 3 | P=0.424 P=0.413N P=0.276N P=0.033N* P=0.564 |
|POLY 1.5 | P=0.480 P=0.405N P=0.291N P=0.031N* P=0.550N |
|POLY 6 | P=0.345 P=0.429N P=0.267N P=0.036N* P=0.468 |
|LOGISTIC REGRESSION| P=0.319 P=0.399N P=0.277N P=0.036N* P=0.543 |
|COCH-ARM / FISHERS | P=0.544 P=0.417N P=0.335N P=0.035N* P=0.500N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/49 (2%) 0/49 (0%) 3/50 (6%) 1/50 (2%) 2/49 (4%) |
|POLY-3 RATE (b) | 1/45.22 0/45.69 3/48.20 1/45.55 2/39.34 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 6.2% 2.2% 5.1% |
|TERMINAL (d) | 1/39 (3%) 0/41 (0%) 1/40 (3%) 0/38 (0%) 1/20 (5%) |
|FIRST INCIDENCE | 729 (T) --- 592 707 681 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.201 P=0.490N P=0.327 P=0.755 P=0.301 |
|POLY 3 | P=0.339 P=0.498N P=0.329 P=0.759N P=0.452 |
|POLY 1.5 | P=0.366 P=0.498N P=0.324 P=0.756N P=0.476 |
|POLY 6 | P=0.299 P=0.498N P=0.333 P=0.759 P=0.415 |
|LOGISTIC REGRESSION| P=0.398 (e) P=0.289 P=0.763 P=0.407 |
|COCH-ARM / FISHERS | P=0.398 P=0.500N P=0.316 P=0.747N P=0.500 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.50 0/46.16 0/47.70 0/45.46 2/39.85 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 5.0% |
|TERMINAL (d) | 0/39 (0%) 0/41 (0%) 0/40 (0%) 0/38 (0%) 1/20 (5%) |
|FIRST INCIDENCE | --- --- --- --- 675 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** (e) (e) (e) P=0.130 |
|POLY 3 | P=0.016 * (e) (e) (e) P=0.209 |
|POLY 1.5 | P=0.017 * (e) (e) (e) P=0.223 |
|POLY 6 | P=0.014 * (e) (e) (e) P=0.188 |
|LOGISTIC REGRESSION| P=0.015 * (e) (e) (e) P=0.200 |
|COCH-ARM / FISHERS | P=0.020 * (e) (e) (e) P=0.247 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 2/49 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.83 2/46.16 2/46.70 1/46.12 0/39.65 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 4.3% 2.2% 0.0% |
|TERMINAL (d) | 0/39 (0%) 2/41 (5%) 2/39 (5%) 0/38 (0%) 0/20 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 507 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.379N P=0.249 P=0.238 P=0.512 (e) |
|POLY 3 | P=0.293N P=0.244 P=0.246 P=0.506 (e) |
|POLY 1.5 | P=0.274N P=0.244 P=0.244 P=0.507 (e) |
|POLY 6 | P=0.323N P=0.242 P=0.247 P=0.503 (e) |
|LOGISTIC REGRESSION| P=0.235N P=0.249 P=0.238 P=0.366 (e) |
|COCH-ARM / FISHERS | P=0.255N P=0.253 P=0.247 P=0.505 (e) |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 4/50 (8%) 3/50 (6%) 33/50 (66%) |
|POLY-3 RATE (b) | 3/45.50 2/46.16 4/48.20 3/45.55 33/46.49 |
|POLY-3 PERCENT (g) | 6.6% 4.3% 8.3% 6.6% 71.0% |
|TERMINAL (d) | 3/39 (8%) 2/41 (5%) 2/40 (5%) 2/38 (5%) 10/20 (50%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 592 707 550 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.477N P=0.522 P=0.650 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.493N P=0.531 P=0.662N P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.494N P=0.522 P=0.659N P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.495N P=0.540 P=0.658 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.477N P=0.504 P=0.653 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.500 P=0.661N P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 3/50 (6%) 4/50 (8%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.50 3/46.80 3/48.03 4/46.87 0/39.65 |
|POLY-3 PERCENT (g) | 0.0% 6.4% 6.3% 8.5% 0.0% |
|TERMINAL (d) | 0/39 (0%) 1/41 (2%) 1/40 (3%) 1/38 (3%) 0/20 (0%) |
|FIRST INCIDENCE | --- 596 657 507 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.360N P=0.128 P=0.134 P=0.067 (e) |
|POLY 3 | P=0.302N P=0.124 P=0.129 P=0.064 (e) |
|POLY 1.5 | P=0.263N P=0.123 P=0.126 P=0.064 (e) |
|POLY 6 | P=0.368N P=0.125 P=0.132 P=0.064 (e) |
|LOGISTIC REGRESSION| P=0.174N P=0.106 P=0.113 P=0.036 * (e) |
|COCH-ARM / FISHERS | P=0.226N P=0.121 P=0.121 P=0.059 (e) |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/46.22 2/46.50 1/47.70 3/45.49 2/39.99 |
|POLY-3 PERCENT (g) | 6.5% 4.3% 2.1% 6.6% 5.0% |
|TERMINAL (d) | 2/39 (5%) 1/41 (2%) 1/40 (3%) 2/38 (5%) 1/20 (5%) |
|FIRST INCIDENCE | 475 634 729 (T) 720 633 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.388 P=0.487N P=0.298N P=0.654 P=0.667 |
|POLY 3 | P=0.540 P=0.497N P=0.294N P=0.655 P=0.565N |
|POLY 1.5 | P=0.580 P=0.496N P=0.297N P=0.661 P=0.533N |
|POLY 6 | P=0.481 P=0.498N P=0.293N P=0.647 P=0.615N |
|LOGISTIC REGRESSION| P=0.558N P=0.541N P=0.359N P=0.656 P=0.474N |
|COCH-ARM / FISHERS | P=0.590N P=0.500N P=0.309N P=0.661N P=0.500N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 32/50 (64%) 27/50 (54%) 28/50 (56%) 23/50 (46%) 17/50 (34%) |
|POLY-3 RATE (b) | 32/47.25 27/46.47 28/48.63 23/47.75 17/42.90 |
|POLY-3 PERCENT (g) | 67.7% 58.1% 57.6% 48.2% 39.6% |
|TERMINAL (d) | 27/39 (69%) 25/41 (61%) 26/40 (65%) 16/38 (42%) 8/20 (40%) |
|FIRST INCIDENCE | 475 681 567 507 559 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.537 P=0.147N P=0.218N P=0.093N P=0.414N |
|POLY 3 | P=0.006N** P=0.222N P=0.205N P=0.039N* P=0.004N** |
|POLY 1.5 | P=0.003N** P=0.205N P=0.218N P=0.040N* P=0.003N** |
|POLY 6 | P=0.014N* P=0.248N P=0.199N P=0.039N* P=0.011N* |
|LOGISTIC REGRESSION| P=0.009N** P=0.175N P=0.200N P=0.050N P=0.006N** |
|COCH-ARM / FISHERS | P=0.002N** P=0.208N P=0.270N P=0.054N P=0.002N** |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 29/50 (58%) 31/50 (62%) 31/50 (62%) 33/50 (66%) 41/50 (82%) |
|POLY-3 RATE (b) | 29/49.02 31/49.21 31/50.00 33/48.83 41/48.95 |
|POLY-3 PERCENT (g) | 59.2% 63.0% 62.0% 67.6% 83.8% |
|TERMINAL (d) | 19/39 (49%) 23/41 (56%) 21/40 (53%) 23/38 (61%) 13/20 (65%) |
|FIRST INCIDENCE | 475 542 567 507 356 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.507 P=0.505 P=0.281 P<0.001 ** |
|POLY 3 | P=0.003 ** P=0.428 P=0.467 P=0.257 P=0.005 ** |
|POLY 1.5 | P=0.003 ** P=0.435 P=0.462 P=0.273 P=0.006 ** |
|POLY 6 | P=0.002 ** P=0.421 P=0.468 P=0.236 P=0.004 ** |
|LOGISTIC REGRESSION| P=0.014 * P=0.404 P=0.363 P=0.263 P=0.016 * |
|COCH-ARM / FISHERS | P=0.004 ** P=0.419 P=0.419 P=0.268 P=0.008 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 0.1 0.3 1.0 3.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 44/50 (88%) 45/50 (90%) 47/50 (94%) 42/50 (84%) 47/50 (94%) |
|POLY-3 RATE (b) | 44/49.02 45/49.21 47/50.00 42/49.39 47/50.00 |
|POLY-3 PERCENT (g) | 89.8% 91.4% 94.0% 85.0% 94.0% |
|TERMINAL (d) | 34/39 (87%) 37/41 (90%) 37/40 (93%) 31/38 (82%) 17/20 (85%) |
|FIRST INCIDENCE | 475 542 567 507 356 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.514N P=0.460 P=0.496N P<0.001 ** |
|POLY 3 | P=0.396 P=0.524 P=0.344 P=0.344N P=0.344 |
|POLY 1.5 | P=0.379 P=0.540 P=0.330 P=0.333N P=0.330 |
|POLY 6 | P=0.404 P=0.506 P=0.346 P=0.365N P=0.346 |
|LOGISTIC REGRESSION| P=0.267 P=0.565 P=0.314 P=0.362N P=0.221 |
|COCH-ARM / FISHERS | P=0.312 P=0.500 P=0.243 P=0.387N P=0.243 |
|=================================================================================================================================|
(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).