TDMS Study 05161-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst RIDDELLIINE DATE: 12/15/00
EXPERIMENT: 05161 TEST: 05 TIME: 12:17:58
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-55393 ROUTE: GAVAGE NTP C#: 61358C
PATHOLOGIST: HEATH, JAMES E. CAS: 23246-96-0
------------------------------------------------------------------------------------------------------------------------------------
RATS/FINAL#1_FEMALES
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 003 0 MG/KG/DY
INCLUDE 004 0.01 MG/KG/DY
INCLUDE 005 0.033 MG/KG/DY
INCLUDE 006 0.1 MG/KG/DY
INCLUDE 007 0.33 MG/KG/DY
INCLUDE 008 1.0 MG/KG/DY
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst RIDDELLIINE DATE: 12/15/00
EXPERIMENT: 05161 TEST: 05 TIME: 12:17:58
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55393 ROUTE: GAVAGE NTP C#: 61358C
PATHOLOGIST: HEATH, JAMES E. CAS: 23246-96-0
Rats(FISCHER 344)
-----------------------------
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
Brain
Clitoral/Preputial Gland
Islets, Pancreatic
Liver
Lung
Ovary
Pancreas
Pituitary Gland
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst RIDDELLIINE DATE: 12/15/00
EXPERIMENT: 05161 TEST: 05 TIME: 12:17:58
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55393 ROUTE: GAVAGE NTP C#: 61358C
PATHOLOGIST: HEATH, JAMES E. CAS: 23246-96-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF RIDDELLIINE
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Benign
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Liver Hemangiosarcoma
Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
Uterus Polyp Stromal
Sarcoma Stromal
Sarcoma Stromal or Polyp Stromal
All Organs Hemangiosarcoma
Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 5/49 (10%) 2/50 (4%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.87 5/39.41 2/41.60 1/40.79 3/42.37 1/18.33 |
|POLY-3 PERCENT (g) | 2.3% 12.7% 4.8% 2.5% 7.1% 5.5% |
|TERMINAL (d) | 1/33 (3%) 4/22 (18%) 2/28 (7%) 1/22 (5%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 715 729 (T) 729 (T) 671 472 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.166 P=0.038 * P=0.442 P=0.669 P=0.266 P=0.429 |
|POLY 3 | P=0.538 P=0.082 P=0.490 P=0.750 P=0.301 P=0.552 |
|POLY 1.5 | P=0.475N P=0.089 P=0.496 P=0.753 P=0.304 P=0.655 |
|POLY 6 | P=0.453 P=0.071 P=0.478 P=0.742 P=0.292 P=0.424 |
|LOGISTIC REGRESSION| P=0.459 P=0.046 * P=0.442 P=0.669 P=0.295 P=0.840 |
|COCH-ARM / FISHERS | P=0.299N P=0.098 P=0.500 P=0.753N P=0.309 P=0.753N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 5/49 (10%) 3/50 (6%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/43.28 5/39.41 3/42.12 1/40.79 3/42.37 1/18.33 |
|POLY-3 PERCENT (g) | 4.6% 12.7% 7.1% 2.5% 7.1% 5.5% |
|TERMINAL (d) | 1/33 (3%) 4/22 (18%) 2/28 (7%) 1/22 (5%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | 611 715 572 729 (T) 671 472 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.300 P=0.105 P=0.449 P=0.593N P=0.450 P=0.483 |
|POLY 3 | P=0.469N P=0.178 P=0.488 P=0.521N P=0.490 P=0.666 |
|POLY 1.5 | P=0.356N P=0.192 P=0.495 P=0.513N P=0.497 P=0.645N |
|POLY 6 | P=0.587 P=0.157 P=0.473 P=0.535N P=0.476 P=0.502 |
|LOGISTIC REGRESSION| P=0.523N P=0.162 P=0.502 P=0.509N P=0.499 P=0.570N |
|COCH-ARM / FISHERS | P=0.202N P=0.210 P=0.500 P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/49 (14%) 7/49 (14%) 8/49 (16%) 10/48 (21%) 4/49 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 7/41.95 7/39.59 8/42.00 10/40.42 4/41.62 2/18.54 |
|POLY-3 PERCENT (g) | 16.7% 17.7% 19.1% 24.7% 9.6% 10.8% |
|TERMINAL (d) | 7/33 (21%) 5/22 (23%) 5/28 (18%) 7/22 (32%) 3/29 (10%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 719 532 651 686 503 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.272 P=0.300 P=0.381 P=0.080 P=0.337N P=0.021 * |
|POLY 3 | P=0.149N P=0.569 P=0.501 P=0.263 P=0.263N P=0.430N |
|POLY 1.5 | P=0.074N P=0.591 P=0.504 P=0.269 P=0.260N P=0.222N |
|POLY 6 | P=0.223N P=0.528 P=0.489 P=0.247 P=0.276N P=0.533 |
|LOGISTIC REGRESSION| P=0.612 P=0.363 P=0.465 P=0.176 P=0.320N P=0.347 |
|COCH-ARM / FISHERS | P=0.015N* P=0.613N P=0.500 P=0.281 P=0.262N P=0.075N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 2/49 (4%) 4/49 (8%) 3/48 (6%) 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/42.73 2/40.36 4/41.67 3/40.00 2/41.46 0/17.60 |
|POLY-3 PERCENT (g) | 7.0% 5.0% 9.6% 7.5% 4.8% 0.0% |
|TERMINAL (d) | 2/33 (6%) 1/22 (5%) 3/28 (11%) 2/22 (9%) 2/29 (7%) 0/0 (0%) |
|FIRST INCIDENCE | 437 407 562 715 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.379N P=0.610N P=0.442 P=0.504 P=0.545N P=0.536N |
|POLY 3 | P=0.220N P=0.526N P=0.486 P=0.632 P=0.514N P=0.341N |
|POLY 1.5 | P=0.139N P=0.513N P=0.494 P=0.640 P=0.506N P=0.219N |
|POLY 6 | P=0.350N P=0.550N P=0.472 P=0.616 P=0.529N P=0.515N |
|LOGISTIC REGRESSION| P=0.074N P=0.463N P=0.500 P=0.654 P=0.502N P=0.110N |
|COCH-ARM / FISHERS | P=0.060N P=0.500N P=0.500 P=0.651 P=0.500N P=0.117N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 10/49 (20%) 9/49 (18%) 12/49 (24%) 13/48 (27%) 6/49 (12%) 2/50 (4%) |
|POLY-3 RATE (b) | 10/42.73 9/40.42 12/42.54 13/40.48 6/41.62 2/18.54 |
|POLY-3 PERCENT (g) | 23.4% 22.3% 28.2% 32.1% 14.4% 10.8% |
|TERMINAL (d) | 9/33 (27%) 6/22 (27%) 8/28 (29%) 9/22 (41%) 5/29 (17%) 0/0 (0%) |
|FIRST INCIDENCE | 437 407 532 651 686 503 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.518 P=0.361 P=0.278 P=0.069 P=0.285N P=0.197 |
|POLY 3 | P=0.072N P=0.555N P=0.397 P=0.258 P=0.218N P=0.245N |
|POLY 1.5 | P=0.022N* P=0.528N P=0.403 P=0.272 P=0.211N P=0.078N |
|POLY 6 | P=0.153N P=0.604 P=0.383 P=0.234 P=0.235N P=0.582N |
|LOGISTIC REGRESSION| P=0.170N P=0.546N P=0.393 P=0.250 P=0.218N P=0.525N |
|COCH-ARM / FISHERS | P=0.002N** P=0.500N P=0.405 P=0.297 P=0.207N P=0.013N* |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Large: Colon/Rectum |
| Lipoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.87 2/39.94 0/41.60 0/40.79 0/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 0.0% 5.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 2/22 (9%) 0/28 (0%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.817N P=0.154 (e) (e) (e) (e) |
|POLY 3 | P=0.341N P=0.221 (e) (e) (e) (e) |
|POLY 1.5 | P=0.371N P=0.229 (e) (e) (e) (e) |
|POLY 6 | P=0.383N P=0.209 (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.154 (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.393N P=0.247 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 4/50 (8%) 0/46 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.87 2/39.94 4/41.66 0/39.53 1/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 4.7% 5.0% 9.6% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 2/33 (6%) 2/22 (9%) 3/28 (11%) 0/22 (0%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 715 --- 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.450N P=0.542 P=0.267 P=0.331N P=0.545N P=1.000N |
|POLY 3 | P=0.168N P=0.669 P=0.323 P=0.255N P=0.507N P=0.457N |
|POLY 1.5 | P=0.139N P=0.681 P=0.331 P=0.255N P=0.502N P=0.349N |
|POLY 6 | P=0.210N P=0.647 P=0.308 P=0.260N P=0.519N P=0.589N |
|LOGISTIC REGRESSION| P=0.463N P=0.542 P=0.271 (e) P=0.545N (e) |
|COCH-ARM / FISHERS | P=0.091N P=0.691N P=0.339 P=0.269N P=0.500N P=0.247N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 5/50 (10%) 0/46 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.87 2/39.94 5/41.66 0/39.53 1/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 4.7% 5.0% 12.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 2/33 (6%) 2/22 (9%) 4/28 (14%) 0/22 (0%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 715 --- 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.389N P=0.542 P=0.157 P=0.331N P=0.545N P=1.000 |
|POLY 3 | P=0.140N P=0.669 P=0.203 P=0.255N P=0.507N P=0.457N |
|POLY 1.5 | P=0.114N P=0.681 P=0.211 P=0.255N P=0.502N P=0.349N |
|POLY 6 | P=0.174N P=0.647 P=0.190 P=0.260N P=0.519N P=0.589N |
|LOGISTIC REGRESSION| P=0.402N P=0.542 P=0.158 (e) P=0.545N (e) |
|COCH-ARM / FISHERS | P=0.072N P=0.691N P=0.218 P=0.269N P=0.500N P=0.247N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 38/50 (76%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 0/41.60 0/40.79 3/42.84 38/42.35 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 7.0% 89.7% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 524 350 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.114 P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.118 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.119 P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.114 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.114 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.121 P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 7/50 (14%) |
|POLY-3 RATE (b) | 1/42.87 0/39.94 0/41.60 0/40.79 1/41.99 7/21.65 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% 2.4% 32.3% |
|TERMINAL (d) | 1/33 (3%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- 729 (T) 426 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.581N P=0.533N P=0.581N P=0.733 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.514N P=0.506N P=0.510N P=0.756 P=0.002 ** |
|POLY 1.5 | P<0.001 ** P=0.507N P=0.503N P=0.507N P=0.759 P=0.007 ** |
|POLY 6 | P<0.001 ** P=0.526N P=0.513N P=0.517N P=0.749 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.733 P=0.030 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.500N P=0.500N P=0.753N P=0.030 * |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY 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) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 8/50 (16%) |
|POLY-3 RATE (b) | 1/42.87 0/39.94 0/41.60 0/40.79 2/41.99 8/22.17 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% 4.8% 36.1% |
|TERMINAL (d) | 1/33 (3%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 2/29 (7%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- 729 (T) 426 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.581N P=0.533N P=0.581N P=0.455 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.514N P=0.506N P=0.510N P=0.493 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.507N P=0.503N P=0.507N P=0.498 P=0.003 ** |
|POLY 6 | P<0.001 ** P=0.526N P=0.513N P=0.517N P=0.481 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.455 P=0.013 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.500N P=0.500N P=0.500 P=0.015 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY 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) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 8/50 (16%) |
|POLY-3 RATE (b) | 1/42.87 0/39.94 0/41.60 0/40.79 2/41.99 8/22.17 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% 4.8% 36.1% |
|TERMINAL (d) | 1/33 (3%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 2/29 (7%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- 729 (T) 426 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.581N P=0.533N P=0.581N P=0.455 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.514N P=0.506N P=0.510N P=0.493 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.507N P=0.503N P=0.507N P=0.498 P=0.003 ** |
|POLY 6 | P<0.001 ** P=0.526N P=0.513N P=0.517N P=0.481 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.455 P=0.013 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.500N P=0.500N P=0.500 P=0.015 * |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.87 0/39.94 0/41.60 3/41.13 2/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 4.7% 0.0% 0.0% 7.3% 4.8% 0.0% |
|TERMINAL (d) | 2/33 (6%) 0/22 (0%) 0/28 (0%) 1/22 (5%) 2/29 (7%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 658 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.562 P=0.331N P=0.275N P=0.364 P=0.648 P=1.000N |
|POLY 3 | P=0.538 P=0.253N P=0.244N P=0.481 P=0.687 P=0.457N |
|POLY 1.5 | P=0.494N P=0.245N P=0.240N P=0.487 P=0.692 P=0.349N |
|POLY 6 | P=0.362 P=0.267N P=0.251N P=0.469 P=0.675 P=0.589N |
|LOGISTIC REGRESSION| P=0.628 (e) (e) P=0.462 P=0.648 (e) |
|COCH-ARM / FISHERS | P=0.324N P=0.247N P=0.247N P=0.500 P=0.691N P=0.247N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY 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) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.87 0/39.94 0/41.60 3/41.13 3/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 4.7% 0.0% 0.0% 7.3% 7.2% 0.0% |
|TERMINAL (d) | 2/33 (6%) 0/22 (0%) 0/28 (0%) 1/22 (5%) 3/29 (10%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 658 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.311 P=0.331N P=0.275N P=0.364 P=0.441 P=1.000N |
|POLY 3 | P=0.383 P=0.253N P=0.244N P=0.481 P=0.490 P=0.457N |
|POLY 1.5 | P=0.587N P=0.245N P=0.240N P=0.487 P=0.497 P=0.349N |
|POLY 6 | P=0.170 P=0.267N P=0.251N P=0.469 P=0.475 P=0.589N |
|LOGISTIC REGRESSION| P=0.396 (e) (e) P=0.462 P=0.441 (e) |
|COCH-ARM / FISHERS | P=0.366N P=0.247N P=0.247N P=0.500 P=0.500 P=0.247N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 0/50 (0%) 4/50 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/43.28 3/40.80 2/41.66 0/40.79 4/42.15 1/18.17 |
|POLY-3 PERCENT (g) | 4.6% 7.4% 4.8% 0.0% 9.5% 5.5% |
|TERMINAL (d) | 1/33 (3%) 1/22 (5%) 1/28 (4%) 0/22 (0%) 3/29 (10%) 0/0 (0%) |
|FIRST INCIDENCE | 611 520 715 --- 686 552 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.078 P=0.406 P=0.645 P=0.284N P=0.287 P=0.358 |
|POLY 3 | P=0.334 P=0.473 P=0.681 P=0.250N P=0.324 P=0.664 |
|POLY 1.5 | P=0.524 P=0.486 P=0.688 P=0.246N P=0.333 P=0.646N |
|POLY 6 | P=0.210 P=0.449 P=0.667 P=0.260N P=0.308 P=0.500 |
|LOGISTIC REGRESSION| P=0.564 P=0.519 P=0.689 P=0.235N P=0.326 P=0.759N |
|COCH-ARM / FISHERS | P=0.436N P=0.500 P=0.691N P=0.247N P=0.339 P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 2/50 (4%) 1/50 (2%) 4/50 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/43.28 4/40.80 2/41.66 1/40.93 4/42.15 1/18.17 |
|POLY-3 PERCENT (g) | 6.9% 9.8% 4.8% 2.4% 9.5% 5.5% |
|TERMINAL (d) | 2/33 (6%) 2/22 (9%) 1/28 (4%) 0/22 (0%) 3/29 (10%) 0/0 (0%) |
|FIRST INCIDENCE | 611 520 715 691 686 552 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.151 P=0.359 P=0.562N P=0.401N P=0.436 P=0.358 |
|POLY 3 | P=0.497 P=0.468 P=0.517N P=0.325N P=0.486 P=0.619N |
|POLY 1.5 | P=0.475N P=0.483 P=0.508N P=0.318N P=0.495 P=0.475N |
|POLY 6 | P=0.368 P=0.439 P=0.535N P=0.339N P=0.466 P=0.557 |
|LOGISTIC REGRESSION| P=0.649N P=0.500 P=0.515N P=0.314N P=0.482 P=0.728N |
|COCH-ARM / FISHERS | P=0.270N P=0.500 P=0.500N P=0.309N P=0.500 P=0.309N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 28/50 (56%) 21/50 (42%) 26/50 (52%) 24/50 (48%) 23/50 (46%) 3/50 (6%) |
|POLY-3 RATE (b) | 28/43.61 21/42.70 26/44.59 24/43.11 23/44.66 3/19.53 |
|POLY-3 PERCENT (g) | 64.2% 49.2% 58.3% 55.7% 51.5% 15.4% |
|TERMINAL (d) | 24/33 (73%) 12/22 (55%) 18/28 (64%) 12/22 (55%) 15/29 (52%) 0/0 (0%) |
|FIRST INCIDENCE | 611 513 562 638 570 461 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.239 P=0.472 P=0.432 P=0.260 P=0.415N P=0.045 * |
|POLY 3 | P=0.006N** P=0.105N P=0.358N P=0.269N P=0.151N P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.106N P=0.379N P=0.283N P=0.170N P<0.001N** |
|POLY 6 | P=0.112N P=0.117N P=0.346N P=0.254N P=0.140N P=0.080N |
|LOGISTIC REGRESSION| P=0.033N* P=0.219N P=0.510N P=0.392N P=0.250N P=0.428N |
|COCH-ARM / FISHERS | P<0.001N** P=0.115N P=0.421N P=0.274N P=0.212N P<0.001N** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 28/50 (56%) 21/50 (42%) 26/50 (52%) 24/50 (48%) 24/50 (48%) 3/50 (6%) |
|POLY-3 RATE (b) | 28/43.61 21/42.70 26/44.59 24/43.11 24/44.66 3/19.53 |
|POLY-3 PERCENT (g) | 64.2% 49.2% 58.3% 55.7% 53.7% 15.4% |
|TERMINAL (d) | 24/33 (73%) 12/22 (55%) 18/28 (64%) 12/22 (55%) 16/29 (55%) 0/0 (0%) |
|FIRST INCIDENCE | 611 513 562 638 570 461 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.189 P=0.472 P=0.432 P=0.260 P=0.497N P=0.045 * |
|POLY 3 | P=0.009N** P=0.105N P=0.358N P=0.269N P=0.208N P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.106N P=0.379N P=0.283N P=0.229N P<0.001N** |
|POLY 6 | P=0.162N P=0.117N P=0.346N P=0.254N P=0.196N P=0.080N |
|LOGISTIC REGRESSION| P=0.045N* P=0.219N P=0.510N P=0.392N P=0.326N P=0.428N |
|COCH-ARM / FISHERS | P<0.001N** P=0.115N P=0.421N P=0.274N P=0.274N P<0.001N** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 30/50 (60%) 23/50 (46%) 27/50 (54%) 24/50 (48%) 25/50 (50%) 4/50 (8%) |
|POLY-3 RATE (b) | 30/44.02 23/43.56 27/44.65 24/43.11 25/44.66 4/20.10 |
|POLY-3 PERCENT (g) | 68.2% 52.8% 60.5% 55.7% 56.0% 19.9% |
|TERMINAL (d) | 25/33 (76%) 12/22 (55%) 18/28 (64%) 12/22 (55%) 17/29 (59%) 0/0 (0%) |
|FIRST INCIDENCE | 611 513 562 638 570 461 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.108 P=0.449 P=0.497 P=0.382 P=0.433N P=0.015 * |
|POLY 3 | P=0.008N** P=0.094N P=0.289N P=0.153N P=0.157N P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.099N P=0.305N P=0.162N P=0.172N P<0.001N** |
|POLY 6 | P=0.151N P=0.101N P=0.286N P=0.146N P=0.154N P=0.080N |
|LOGISTIC REGRESSION| P=0.035N* P=0.190N P=0.416N P=0.223N P=0.244N P=0.335N |
|COCH-ARM / FISHERS | P<0.001N** P=0.115N P=0.343N P=0.158N P=0.211N P<0.001N** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Papilloma Squamous or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 2/41.66 1/40.79 0/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 2.5% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 1/28 (4%) 1/22 (5%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 715 729 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.839N (e) P=0.209 P=0.419 (e) (e) |
|POLY 3 | P=0.381N (e) P=0.230 P=0.490 (e) (e) |
|POLY 1.5 | P=0.372N (e) P=0.234 P=0.493 (e) (e) |
|POLY 6 | P=0.459N (e) P=0.223 P=0.483 (e) (e) |
|LOGISTIC REGRESSION| P=0.822N (e) P=0.213 P=0.419 (e) (e) |
|COCH-ARM / FISHERS | P=0.350N (e) P=0.247 P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 2/41.66 2/40.79 0/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 4.9% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 1/28 (4%) 2/22 (9%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 715 729 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.809N (e) P=0.209 P=0.154 (e) (e) |
|POLY 3 | P=0.369N (e) P=0.230 P=0.226 (e) (e) |
|POLY 1.5 | P=0.340N (e) P=0.234 P=0.230 (e) (e) |
|POLY 6 | P=0.462N (e) P=0.223 P=0.218 (e) (e) |
|LOGISTIC REGRESSION| P=0.802N (e) P=0.213 P=0.154 (e) (e) |
|COCH-ARM / FISHERS | P=0.295N (e) P=0.247 P=0.247 (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 27/50 (54%) 22/48 (46%) 21/50 (42%) 17/49 (35%) 24/50 (48%) 7/49 (14%) |
|POLY-3 RATE (b) | 27/45.27 22/40.38 21/44.38 17/42.07 24/44.89 7/20.92 |
|POLY-3 PERCENT (g) | 59.7% 54.5% 47.3% 40.4% 53.5% 33.5% |
|TERMINAL (d) | 18/33 (55%) 16/21 (76%) 13/28 (46%) 9/22 (41%) 16/29 (55%) 0/0 (0%) |
|FIRST INCIDENCE | 545 520 518 561 524 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.304 P=0.375N P=0.327N P=0.553N P<0.001 ** |
|POLY 3 | P=0.150N P=0.393N P=0.163N P=0.051N P=0.349N P=0.049N* |
|POLY 1.5 | P=0.016N* P=0.329N P=0.153N P=0.047N* P=0.335N P=0.002N** |
|POLY 6 | P=0.509N P=0.519N P=0.196N P=0.064N P=0.399N P=0.498N |
|LOGISTIC REGRESSION| P=0.299N P=0.402N P=0.174N P=0.051N P=0.361N P=0.428N |
|COCH-ARM / FISHERS | P<0.001N** P=0.272N P=0.158N P=0.041N* P=0.345N P<0.001N** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.87 1/40.08 2/41.60 0/40.79 0/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 2.3% 2.5% 4.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/33 (3%) 0/22 (0%) 2/28 (7%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 693 729 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.548N P=0.686 P=0.442 P=0.581N P=0.526N P=1.000 |
|POLY 3 | P=0.202N P=0.746 P=0.490 P=0.510N P=0.504N P=0.650N |
|POLY 1.5 | P=0.216N P=0.753 P=0.496 P=0.507N P=0.501N P=0.586N |
|POLY 6 | P=0.208N P=0.733 P=0.478 P=0.517N P=0.511N P=0.716N |
|LOGISTIC REGRESSION| P=0.503N P=0.735 P=0.442 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.209N P=0.753N P=0.500 P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.87 3/40.38 3/41.60 0/40.79 0/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 2.3% 7.4% 7.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/33 (3%) 1/22 (5%) 3/28 (11%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 647 729 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.264N P=0.207 P=0.247 P=0.581N P=0.526N P=1.000 |
|POLY 3 | P=0.099N P=0.284 P=0.294 P=0.510N P=0.504N P=0.650N |
|POLY 1.5 | P=0.103N P=0.294 P=0.301 P=0.507N P=0.501N P=0.586N |
|POLY 6 | P=0.093N P=0.267 P=0.282 P=0.517N P=0.511N P=0.716N |
|LOGISTIC REGRESSION| P=0.216N P=0.277 P=0.247 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.089N P=0.309 P=0.309 P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 5/50 (10%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/43.58 0/39.94 5/42.18 3/41.17 0/41.99 1/18.37 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 11.9% 7.3% 0.0% 5.4% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 3/28 (11%) 1/22 (5%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 483 --- 647 638 --- 447 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.558 P=0.496N P=0.088 P=0.252 P=0.496N P=0.686 |
|POLY 3 | P=0.369N P=0.517N P=0.093 P=0.285 P=0.507N P=0.549 |
|POLY 1.5 | P=0.351N P=0.509N P=0.097 P=0.292 P=0.503N P=0.652 |
|POLY 6 | P=0.356N P=0.530N P=0.087 P=0.273 P=0.515N P=0.422 |
|LOGISTIC REGRESSION| P=0.259N P=0.441N P=0.105 P=0.325 P=0.639N P=0.391N |
|COCH-ARM / FISHERS | P=0.277N P=0.500N P=0.102 P=0.309 P=0.500N P=0.753N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 5/50 (10%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/44.26 0/39.94 5/42.18 3/41.17 0/41.99 1/18.37 |
|POLY-3 PERCENT (g) | 6.8% 0.0% 11.9% 7.3% 0.0% 5.4% |
|TERMINAL (d) | 1/33 (3%) 0/22 (0%) 3/28 (11%) 1/22 (5%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 483 --- 647 638 --- 447 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.670N P=0.143N P=0.316 P=0.577 P=0.128N P=0.636N |
|POLY 3 | P=0.239N P=0.138N P=0.330 P=0.629 P=0.128N P=0.622N |
|POLY 1.5 | P=0.229N P=0.129N P=0.343 P=0.640 P=0.123N P=0.478N |
|POLY 6 | P=0.210N P=0.153N P=0.311 P=0.611 P=0.137N P=0.555 |
|LOGISTIC REGRESSION| P=0.119N P=0.091N P=0.359 P=0.628N P=0.143N P=0.054N |
|COCH-ARM / FISHERS | P=0.171N P=0.121N P=0.357 P=0.661N P=0.121N P=0.309N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/43.55 0/39.94 0/41.60 0/40.79 0/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 4.6% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/33 (3%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 498 --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.562N P=0.279N P=0.253N P=0.284N P=0.249N P=0.606N |
|POLY 3 | P=0.289N P=0.257N P=0.247N P=0.252N P=0.245N P=0.460N |
|POLY 1.5 | P=0.336N P=0.248N P=0.242N P=0.247N P=0.241N P=0.351N |
|POLY 6 | P=0.290N P=0.272N P=0.256N P=0.261N P=0.254N P=0.592N |
|LOGISTIC REGRESSION| P=0.287N P=0.215N P=0.241N P=0.206N P=0.252N P=0.201N |
|COCH-ARM / FISHERS | P=0.378N P=0.247N P=0.247N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.87 2/40.24 1/41.60 0/40.79 0/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 0.0% 5.0% 2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 1/22 (5%) 1/28 (4%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 647 729 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.646N P=0.179 P=0.467 (e) (e) (e) |
|POLY 3 | P=0.266N P=0.223 P=0.494 (e) (e) (e) |
|POLY 1.5 | P=0.284N P=0.230 P=0.497 (e) (e) (e) |
|POLY 6 | P=0.292N P=0.212 P=0.487 (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.478N P=0.228 P=0.467 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.285N P=0.247 P=0.500 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.87 2/40.24 1/41.60 0/40.79 0/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 0.0% 5.0% 2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 1/22 (5%) 1/28 (4%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 647 729 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.646N P=0.179 P=0.467 (e) (e) (e) |
|POLY 3 | P=0.266N P=0.223 P=0.494 (e) (e) (e) |
|POLY 1.5 | P=0.284N P=0.230 P=0.497 (e) (e) (e) |
|POLY 6 | P=0.292N P=0.212 P=0.487 (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.478N P=0.228 P=0.467 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.285N P=0.247 P=0.500 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 4/50 (8%) 4/49 (8%) 6/49 (12%) 11/50 (22%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.87 4/40.51 4/41.89 6/40.90 11/43.81 0/17.60 |
|POLY-3 PERCENT (g) | 4.8% 9.9% 9.6% 14.7% 25.1% 0.0% |
|TERMINAL (d) | 2/32 (6%) 1/22 (5%) 2/28 (7%) 5/22 (23%) 6/29 (21%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 613 647 682 570 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.029 * P=0.216 P=0.291 P=0.048 * P=0.008 ** P=1.000N |
|POLY 3 | P=0.169 P=0.321 P=0.337 P=0.123 P=0.008 ** P=0.452N |
|POLY 1.5 | P=0.543N P=0.333 P=0.339 P=0.127 P=0.008 ** P=0.343N |
|POLY 6 | P=0.009 ** P=0.300 P=0.328 P=0.114 P=0.008 ** P=0.586N |
|LOGISTIC REGRESSION| P=0.447 P=0.305 P=0.326 P=0.080 P=0.009 ** (e) |
|COCH-ARM / FISHERS | P=0.135N P=0.349 P=0.339 P=0.134 P=0.008 ** P=0.242N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 4/50 (8%) 4/49 (8%) 6/49 (12%) 11/50 (22%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/41.87 4/40.51 4/41.89 6/40.90 11/43.81 0/17.60 |
|POLY-3 PERCENT (g) | 7.2% 9.9% 9.6% 14.7% 25.1% 0.0% |
|TERMINAL (d) | 3/32 (9%) 1/22 (5%) 2/28 (7%) 5/22 (23%) 6/29 (21%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 613 647 682 570 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.041 * P=0.339 P=0.440 P=0.099 P=0.018 * P=1.000N |
|POLY 3 | P=0.212 P=0.482 P=0.500 P=0.228 P=0.023 * P=0.336N |
|POLY 1.5 | P=0.489N P=0.496 P=0.503 P=0.234 P=0.023 * P=0.215N |
|POLY 6 | P=0.016 * P=0.457 P=0.491 P=0.214 P=0.022 * P=0.510N |
|LOGISTIC REGRESSION| P=0.478 P=0.454 P=0.484 P=0.153 P=0.023 * (e) |
|COCH-ARM / FISHERS | P=0.111N P=0.511 P=0.500 P=0.243 P=0.022 * P=0.117N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 2/41.66 0/40.79 0/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 1/28 (4%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 715 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.884N (e) P=0.209 (e) (e) (e) |
|POLY 3 | P=0.393N (e) P=0.230 (e) (e) (e) |
|POLY 1.5 | P=0.412N (e) P=0.234 (e) (e) (e) |
|POLY 6 | P=0.454N (e) P=0.223 (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.849N (e) P=0.213 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.429N (e) P=0.247 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 11/50 (22%) 14/50 (28%) 15/50 (30%) 12/50 (24%) 9/50 (18%) 5/50 (10%) |
|POLY-3 RATE (b) | 11/44.24 14/43.17 15/43.65 12/42.10 9/43.22 5/20.54 |
|POLY-3 PERCENT (g) | 24.9% 32.4% 34.4% 28.5% 20.8% 24.4% |
|TERMINAL (d) | 7/33 (21%) 6/22 (27%) 10/28 (36%) 8/22 (36%) 6/29 (21%) 0/0 (0%) |
|FIRST INCIDENCE | 498 328 518 561 524 447 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.062 P=0.126 P=0.161 P=0.227 P=0.499N P=0.011 * |
|POLY 3 | P=0.207N P=0.291 P=0.227 P=0.445 P=0.423N P=0.593N |
|POLY 1.5 | P=0.081N P=0.310 P=0.239 P=0.463 P=0.408N P=0.309N |
|POLY 6 | P=0.361N P=0.254 P=0.205 P=0.412 P=0.456N P=0.278 |
|LOGISTIC REGRESSION| P=0.057N P=0.333 P=0.238 P=0.463 P=0.405N P=0.501N |
|COCH-ARM / FISHERS | P=0.009N** P=0.322 P=0.247 P=0.500 P=0.402N P=0.086N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 4/50 (8%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 2/42.39 4/41.36 2/42.73 0/17.60 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.7% 9.7% 4.7% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 1/28 (4%) 1/22 (5%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 437 646 463 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.657 (e) P=0.224 P=0.044 * P=0.228 (e) |
|POLY 3 | P=0.504 (e) P=0.234 P=0.055 P=0.236 (e) |
|POLY 1.5 | P=0.496N (e) P=0.237 P=0.057 P=0.238 (e) |
|POLY 6 | P=0.303 (e) P=0.228 P=0.052 P=0.230 (e) |
|LOGISTIC REGRESSION| P=0.243N (e) P=0.217 P=0.059 P=0.205 (e) |
|COCH-ARM / FISHERS | P=0.306N (e) P=0.247 P=0.059 P=0.247 (e) |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 11/50 (22%) 14/50 (28%) 17/50 (34%) 14/50 (28%) 11/50 (22%) 5/50 (10%) |
|POLY-3 RATE (b) | 11/44.24 14/43.17 17/44.44 14/42.19 11/43.96 5/20.54 |
|POLY-3 PERCENT (g) | 24.9% 32.4% 38.3% 33.2% 25.0% 24.4% |
|TERMINAL (d) | 7/33 (21%) 6/22 (27%) 11/28 (39%) 9/22 (41%) 7/29 (24%) 0/0 (0%) |
|FIRST INCIDENCE | 498 328 437 561 463 447 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.065 P=0.126 P=0.082 P=0.108 P=0.496 P=0.011 * |
|POLY 3 | P=0.234N P=0.291 P=0.126 P=0.268 P=0.591 P=0.593N |
|POLY 1.5 | P=0.079N P=0.310 P=0.132 P=0.285 P=0.593N P=0.309N |
|POLY 6 | P=0.449N P=0.254 P=0.112 P=0.238 P=0.563 P=0.278 |
|LOGISTIC REGRESSION| P=0.031N* P=0.333 P=0.132 P=0.283 P=0.595N P=0.501N |
|COCH-ARM / FISHERS | P=0.006N** P=0.322 P=0.133 P=0.322 P=0.595N P=0.086N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 39/50 (78%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 0/41.60 0/40.79 3/42.84 39/42.92 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 7.0% 90.9% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 524 350 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.114 P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.118 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.119 P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.114 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.114 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.121 P<0.001 ** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 12/50 (24%) 8/50 (16%) 13/50 (26%) 18/50 (36%) 18/50 (36%) 14/50 (28%) |
|POLY-3 RATE (b) | 12/44.48 8/42.25 13/43.54 18/44.72 18/46.12 14/27.13 |
|POLY-3 PERCENT (g) | 27.0% 18.9% 29.9% 40.3% 39.0% 51.6% |
|TERMINAL (d) | 8/33 (24%) 1/22 (5%) 7/28 (25%) 6/22 (27%) 6/29 (21%) 0/0 (0%) |
|FIRST INCIDENCE | 393 513 532 451 463 352 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.454N P=0.370 P=0.054 P=0.109 P<0.001 ** |
|POLY 3 | P=0.009 ** P=0.262N P=0.475 P=0.132 P=0.158 P=0.033 * |
|POLY 1.5 | P=0.051 P=0.246N P=0.488 P=0.128 P=0.150 P=0.134 |
|POLY 6 | P<0.001 ** P=0.291N P=0.451 P=0.138 P=0.166 P=0.003 ** |
|LOGISTIC REGRESSION| P=0.460 P=0.215N P=0.496 P=0.139 P=0.138 P=0.544N |
|COCH-ARM / FISHERS | P=0.288 P=0.227N P=0.500 P=0.138 P=0.138 P=0.410 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 45/50 (90%) 42/50 (84%) 45/50 (90%) 41/50 (82%) 45/50 (90%) 22/50 (44%) |
|POLY-3 RATE (b) | 45/47.27 42/46.97 45/48.13 41/44.94 45/47.27 22/30.57 |
|POLY-3 PERCENT (g) | 95.2% 89.4% 93.5% 91.2% 95.2% 72.0% |
|TERMINAL (d) | 32/33 (97%) 21/22 (96%) 27/28 (96%) 22/22 (100%) 29/29 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 483 328 444 561 524 426 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.067 P=0.208 P=0.096 P=0.249 P<0.001 ** |
|POLY 3 | P<0.001N** P=0.218N P=0.538N P=0.342N P=0.727N P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.223N P=0.564N P=0.286N P=0.661N P<0.001N** |
|POLY 6 | P=0.259N P=0.279N P=0.565N P=0.426N P=0.699 P=0.086N |
|LOGISTIC REGRESSION| P=0.225N P=0.341N P=0.617N P=0.179N P=0.523N P=0.252N |
|COCH-ARM / FISHERS | P<0.001N** P=0.277N P=0.630N P=0.194N P=0.630N P<0.001N** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 20/50 (40%) 17/50 (34%) 21/50 (42%) 28/50 (56%) 28/50 (56%) 47/50 (94%) |
|POLY-3 RATE (b) | 20/46.36 17/44.57 21/45.31 28/47.23 28/47.51 47/48.05 |
|POLY-3 PERCENT (g) | 43.1% 38.2% 46.4% 59.3% 58.9% 97.8% |
|TERMINAL (d) | 13/33 (39%) 5/22 (23%) 12/28 (43%) 10/22 (46%) 14/29 (48%) 0/0 (0%) |
|FIRST INCIDENCE | 393 407 437 252 451 350 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.462 P=0.335 P=0.022 * P=0.064 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.392N P=0.460 P=0.083 P=0.088 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.370N P=0.480 P=0.080 P=0.085 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.428N P=0.428 P=0.088 P=0.090 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.290N P=0.510 P=0.098 P=0.082 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.339N P=0.500 P=0.080 P=0.080 P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY 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) | 47/50 (94%) 47/50 (94%) 48/50 (96%) 47/50 (94%) 50/50 (100%) 50/50 (100%) |
|POLY-3 RATE (b) | 47/48.90 47/48.95 48/49.60 47/48.49 50/50.00 50/50.00 |
|POLY-3 PERCENT (g) | 96.1% 96.0% 96.8% 96.9% 100.0% 100.0% |
|TERMINAL (d) | 32/33 (97%) 21/22 (96%) 27/28 (96%) 22/22 (100%) 29/29 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 393 328 437 252 451 350 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.030 * P=0.177 P=0.035 * P=0.136 P<0.001 ** |
|POLY 3 | P=0.080 P=0.710N P=0.658 P=0.645 P=0.222 P=0.222 |
|POLY 1.5 | P=0.058 P=0.686N P=0.595 P=0.632 P=0.165 P=0.165 |
|POLY 6 | P=0.127 P=0.743N P=0.717 P=0.685 P=0.323 P=0.323 |
|LOGISTIC REGRESSION| P=0.007 ** P=0.622 P=0.501 P=0.559 P=0.131 P=0.058 |
|COCH-ARM / FISHERS | P=0.044 * P=0.661N P=0.500 P=0.661N P=0.121 P=0.121 |
|=================================================================================================================================|
(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).