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: 12:19:29
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 MALES
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 MG/KG/DY
INCLUDE 002 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: 12:19:29
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 Medulla
Clitoral/Preputial Gland
Liver
Lung
Pancreas
Pituitary Gland
Testes
Thymus
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst RIDDELLIINE DATE: 12/15/00
EXPERIMENT: 05161 TEST: 05 TIME: 12:19:29
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
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Liver Hemangiosarcoma
Hepatocellular Adenoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Testes Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
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 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/48.84 2/28.50 |
|POLY-3 PERCENT (g) | 4.1% 7.0% |
|TERMINAL (d) | 2/48 (4%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 414 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.078 P=0.078 |
|POLY 3 | P=0.578 P=0.579 |
|POLY 1.5 | P=0.623 P=0.624 |
|POLY 6 | P=0.570 P=0.573 |
|LOGISTIC REGRESSION| P=0.526 P=0.526 |
|COCH-ARM / FISHERS | P=0.688N P=0.684N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/49.84 0/27.85 |
|POLY-3 PERCENT (g) | 4.0% 0.0% |
|TERMINAL (d) | 2/49 (4%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.881N P=0.881N |
|POLY 3 | P=0.520N P=0.520N |
|POLY 1.5 | P=0.368N P=0.368N |
|POLY 6 | P=0.794N P=0.794N |
|LOGISTIC REGRESSION| P=0.881N (e) |
|COCH-ARM / FISHERS | P=0.238N P=0.247N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/49.84 1/28.34 |
|POLY-3 PERCENT (g) | 4.0% 3.5% |
|TERMINAL (d) | 2/49 (4%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 398 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.514 P=0.514 |
|POLY 3 | P=0.770N P=0.770N |
|POLY 1.5 | P=0.648N P=0.648N |
|POLY 6 | P=0.839 P=0.839 |
|LOGISTIC REGRESSION| P=0.714N P=0.714N |
|COCH-ARM / FISHERS | P=0.500N P=0.500N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 43/50 (86%) |
|POLY-3 RATE (b) | 0/49.84 43/46.51 |
|POLY-3 PERCENT (g) | 0.0% 92.5% |
|TERMINAL (d) | 0/49 (0%) 1/3 (33%) |
|FIRST INCIDENCE | --- 307 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/49.84 4/29.17 |
|POLY-3 PERCENT (g) | 0.0% 13.7% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 398 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.033 * P=0.033 * |
|POLY 1.5 | P=0.040 * P=0.040 * |
|POLY 6 | P=0.037 * P=0.037 * |
|LOGISTIC REGRESSION| P=0.039 * P=0.039 * |
|COCH-ARM / FISHERS | P=0.063 P=0.059 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/49.84 3/28.63 |
|POLY-3 PERCENT (g) | 0.0% 10.5% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 415 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.088 P=0.088 |
|POLY 1.5 | P=0.093 P=0.093 |
|POLY 6 | P=0.114 P=0.114 |
|LOGISTIC REGRESSION| P=0.039 * P=0.039 * |
|COCH-ARM / FISHERS | P=0.121 P=0.121 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/49.84 3/28.63 |
|POLY-3 PERCENT (g) | 2.0% 10.5% |
|TERMINAL (d) | 1/49 (2%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 415 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.003 ** |
|POLY 3 | P=0.211 P=0.211 |
|POLY 1.5 | P=0.240 P=0.240 |
|POLY 6 | P=0.220 P=0.220 |
|LOGISTIC REGRESSION| P=0.101 P=0.101 |
|COCH-ARM / FISHERS | P=0.305 P=0.309 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 11/50 (22%) 2/49 (4%) |
|POLY-3 RATE (b) | 11/49.84 2/27.81 |
|POLY-3 PERCENT (g) | 22.1% 7.2% |
|TERMINAL (d) | 11/49 (22%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 414 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.313 P=0.313 |
|POLY 3 | P=0.129N P=0.128N |
|POLY 1.5 | P=0.042N* P=0.042N* |
|POLY 6 | P=0.415N P=0.413N |
|LOGISTIC REGRESSION| P=0.519N P=0.519N |
|COCH-ARM / FISHERS | P=0.010N* P=0.008N** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 12/50 (24%) 2/49 (4%) |
|POLY-3 RATE (b) | 12/49.84 2/27.81 |
|POLY-3 PERCENT (g) | 24.1% 7.2% |
|TERMINAL (d) | 12/49 (25%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 414 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.339 P=0.339 |
|POLY 3 | P=0.095N P=0.094N |
|POLY 1.5 | P=0.027N* P=0.027N* |
|POLY 6 | P=0.360N P=0.358N |
|LOGISTIC REGRESSION| P=0.479N P=0.479N |
|COCH-ARM / FISHERS | P=0.005N** P=0.004N** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | 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) | 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/49.84 1/28.32 |
|POLY-3 PERCENT (g) | 6.0% 3.5% |
|TERMINAL (d) | 3/49 (6%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 402 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.535 P=0.535 |
|POLY 3 | P=0.613N P=0.613N |
|POLY 1.5 | P=0.462N P=0.462N |
|POLY 6 | P=0.832N P=0.832N |
|LOGISTIC REGRESSION| P=0.626N P=0.626N |
|COCH-ARM / FISHERS | P=0.305N P=0.309N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/49.84 0/27.85 |
|POLY-3 PERCENT (g) | 4.0% 0.0% |
|TERMINAL (d) | 2/49 (4%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.881N P=0.881N |
|POLY 3 | P=0.520N P=0.520N |
|POLY 1.5 | P=0.368N P=0.368N |
|POLY 6 | P=0.794N P=0.794N |
|LOGISTIC REGRESSION| P=0.881N (e) |
|COCH-ARM / FISHERS | P=0.238N P=0.247N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/49.84 1/28.32 |
|POLY-3 PERCENT (g) | 4.0% 3.5% |
|TERMINAL (d) | 2/49 (4%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 402 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.499 P=0.499 |
|POLY 3 | P=0.770N P=0.770N |
|POLY 1.5 | P=0.648N P=0.648N |
|POLY 6 | P=0.839 P=0.839 |
|LOGISTIC REGRESSION| P=0.733N P=0.733N |
|COCH-ARM / FISHERS | P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/49.84 1/28.32 |
|POLY-3 PERCENT (g) | 6.0% 3.5% |
|TERMINAL (d) | 3/49 (6%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 402 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.535 P=0.535 |
|POLY 3 | P=0.613N P=0.613N |
|POLY 1.5 | P=0.462N P=0.462N |
|POLY 6 | P=0.832N P=0.832N |
|LOGISTIC REGRESSION| P=0.626N P=0.626N |
|COCH-ARM / FISHERS | P=0.305N P=0.309N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/49.84 1/28.32 |
|POLY-3 PERCENT (g) | 6.0% 3.5% |
|TERMINAL (d) | 3/49 (6%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 402 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.535 P=0.535 |
|POLY 3 | P=0.613N P=0.613N |
|POLY 1.5 | P=0.462N P=0.462N |
|POLY 6 | P=0.832N P=0.832N |
|LOGISTIC REGRESSION| P=0.626N P=0.626N |
|COCH-ARM / FISHERS | P=0.305N P=0.309N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 39/50 (78%) 7/50 (14%) |
|POLY-3 RATE (b) | 39/50.00 7/29.67 |
|POLY-3 PERCENT (g) | 78.0% 23.6% |
|TERMINAL (d) | 38/49 (78%) 2/3 (67%) |
|FIRST INCIDENCE | 468 342 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.010 * P=0.010 * |
|POLY 3 | P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P<0.001N** |
|POLY 6 | P=0.002N** P=0.002N** |
|LOGISTIC REGRESSION| P=0.086N P=0.086N |
|COCH-ARM / FISHERS | P<0.001N** P<0.001N** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) |
|POLY-3 RATE (b) | 3/49.84 3/29.03 |
|POLY-3 PERCENT (g) | 6.0% 10.3% |
|TERMINAL (d) | 3/49 (6%) 1/3 (33%) |
|FIRST INCIDENCE | 497 (T) 307 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.032 * P=0.032 * |
|POLY 3 | P=0.479 P=0.479 |
|POLY 1.5 | P=0.554 P=0.554 |
|POLY 6 | P=0.421 P=0.421 |
|LOGISTIC REGRESSION| P=0.692 P=0.692 |
|COCH-ARM / FISHERS | P=0.663 P=0.661N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) |
|POLY-3 RATE (b) | 4/49.84 3/29.03 |
|POLY-3 PERCENT (g) | 8.0% 10.3% |
|TERMINAL (d) | 4/49 (8%) 1/3 (33%) |
|FIRST INCIDENCE | 497 (T) 307 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.043 * P=0.043 * |
|POLY 3 | P=0.592 P=0.592 |
|POLY 1.5 | P=0.676 P=0.676 |
|POLY 6 | P=0.508 P=0.508 |
|LOGISTIC REGRESSION| P=0.695N P=0.695N |
|COCH-ARM / FISHERS | P=0.500N P=0.500N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 43/50 (86%) |
|POLY-3 RATE (b) | 0/49.84 43/46.51 |
|POLY-3 PERCENT (g) | 0.0% 92.5% |
|TERMINAL (d) | 0/49 (0%) 1/3 (33%) |
|FIRST INCIDENCE | --- 307 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 9/50 (18%) |
|POLY-3 RATE (b) | 2/49.84 9/31.57 |
|POLY-3 PERCENT (g) | 4.0% 28.5% |
|TERMINAL (d) | 2/49 (4%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 204 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.004 ** P=0.004 ** |
|POLY 1.5 | P=0.009 ** P=0.009 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.096 P=0.096 |
|COCH-ARM / FISHERS | P=0.028 * P=0.026 * |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/49.84 2/28.95 |
|POLY-3 PERCENT (g) | 0.0% 6.9% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 297 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.100 P=0.100 |
|POLY 3 | P=0.227 P=0.227 |
|POLY 1.5 | P=0.218 P=0.218 |
|POLY 6 | P=0.311 P=0.311 |
|LOGISTIC REGRESSION| P=0.645 P=0.645 |
|COCH-ARM / FISHERS | P=0.238 P=0.247 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) |
|POLY-3 RATE (b) | 4/50.00 3/29.24 |
|POLY-3 PERCENT (g) | 8.0% 10.3% |
|TERMINAL (d) | 3/49 (6%) 0/3 (0%) |
|FIRST INCIDENCE | 468 327 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.081 P=0.081 |
|POLY 3 | P=0.593 P=0.593 |
|POLY 1.5 | P=0.676 P=0.676 |
|POLY 6 | P=0.509 P=0.509 |
|LOGISTIC REGRESSION| P=0.524N P=0.524N |
|COCH-ARM / FISHERS | P=0.500N P=0.500N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) |
|POLY-3 RATE (b) | 4/50.00 3/29.24 |
|POLY-3 PERCENT (g) | 8.0% 10.3% |
|TERMINAL (d) | 3/49 (6%) 0/3 (0%) |
|FIRST INCIDENCE | 468 327 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.081 P=0.081 |
|POLY 3 | P=0.593 P=0.593 |
|POLY 1.5 | P=0.676 P=0.676 |
|POLY 6 | P=0.509 P=0.509 |
|LOGISTIC REGRESSION| P=0.524N P=0.524N |
|COCH-ARM / FISHERS | P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 47/50 (94%) 15/50 (30%) |
|POLY-3 RATE (b) | 47/50.00 15/32.70 |
|POLY-3 PERCENT (g) | 94.0% 45.9% |
|TERMINAL (d) | 46/49 (94%) 2/3 (67%) |
|FIRST INCIDENCE | 468 307 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P=0.016N* P=0.016N* |
|COCH-ARM / FISHERS | P<0.001N** P<0.001N** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 9/50 (18%) 47/50 (94%) |
|POLY-3 RATE (b) | 9/50.00 47/49.15 |
|POLY-3 PERCENT (g) | 18.0% 95.6% |
|TERMINAL (d) | 8/49 (16%) 1/3 (33%) |
|FIRST INCIDENCE | 468 204 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 47/50 (94%) 49/50 (98%) |
|POLY-3 RATE (b) | 47/50.00 49/49.15 |
|POLY-3 PERCENT (g) | 94.0% 99.7% |
|TERMINAL (d) | 46/49 (94%) 3/3 (100%) |
|FIRST INCIDENCE | 468 204 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.144 P=0.144 |
|POLY 1.5 | P=0.182 P=0.182 |
|POLY 6 | P=0.127 P=0.127 |
|LOGISTIC REGRESSION| P=0.138 P=0.138 |
|COCH-ARM / FISHERS | P=0.305 P=0.309 |
|=================================================================================================================================|
(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).