TDMS Study 93020-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst DIISOPROPYLCARBODIIMIDE DATE: 01/03/05
EXPERIMENT: 93020 TEST: 07 TIME: 09:20:08
TEST TYPE: CHRONIC PAGE: 1
CONT: N01-ES 05451 ROUTE: SKIN APPLICATION NTP C#: 93020D
PATHOLOGIST: HEATH, JAMES CAS: 693-13-0
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: 25022 Accidently Killed
25018 Dosing Accident
25023 Missing
25019 Moribund Sacrifice
25020 Natural Death
25017 Scheduled Sacrifice
25021 Terminal Sacrifice
25007 Wrong Sex
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst DIISOPROPYLCARBODIIMIDE DATE: 01/03/05
EXPERIMENT: 93020 TEST: 07 TIME: 09:20:08
TEST TYPE: CHRONIC
CONT: N01-ES 05451 ROUTE: SKIN APPLICATION NTP C#: 93020D
PATHOLOGIST: HEATH, JAMES CAS: 693-13-0
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
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Pancreas
Parathyroid Gland
Pituitary Gland
Prostate
Salivary Glands
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst DIISOPROPYLCARBODIIMIDE DATE: 01/03/05
EXPERIMENT: 93020 TEST: 07 TIME: 09:20:08
TEST TYPE: CHRONIC
CONT: N01-ES 05451 ROUTE: SKIN APPLICATION NTP C#: 93020D
PATHOLOGIST: HEATH, JAMES CAS: 693-13-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF DIISOPROPYLCARBODIIMIDE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Bone Osteosarcoma or Osteoma
Clitoral/Preputial Gland Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma
Carcinoma or Adenoma
Pituitary Gland: Pars Intermedia Carcinoma or Adenoma
Testes Adenoma
Thyroid Gland: C-Cell Carcinoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Osteosarcoma or Osteoma
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Adenoma
Islets, Pancreatic Adenoma
Carcinoma or Adenoma
Liver Hepatocellular Adenoma
Mammary Gland Carcinoma
Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)
Squamous Cell Carcinoma, Papilloma Squamous,
or Papilloma
Skin Fibroma
Schwannoma Malignant
Thyroid Gland: C-Cell Carcinoma or Adenoma
Uterus Carcinoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Malignant and Benign Tumors
===============================================================
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/40.18 0/40.75 0/44.41 0/28.31 |3/41.69 0/42.03 0/43.75 1/41.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |7.2% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 0/20 (0%) 0/30 (0%) 0/32 (0%) 0/17 (0%) |2/30 (7%) 0/32 (0%) 0/32 (0%) 1/25 (4%) |
|FIRST INCIDENCE | --- --- --- --- |710 --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.285N P=0.110N P=0.112N P=0.372N |
|POLY 3 | (e) (e) (e) (e) |P=0.248N P=0.117N P=0.110N P=0.310N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.248N P=0.118N P=0.113N P=0.308N |
|POLY 6 | (e) (e) (e) (e) |P=0.248N P=0.114N P=0.108N P=0.319N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.264N P=0.111N P=0.106N P=0.339N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.251N P=0.121N P=0.121N P=0.316N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.038N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/48 (4%) 8/50 (16%) 7/50 (14%) |0/49 (0%) 1/50 (2%) 1/50 (2%) 1/49 (2%) |
|POLY-3 RATE (b) | 3/40.23 2/39.75 8/44.41 7/28.90 |0/40.61 1/42.03 1/43.75 1/41.08 |
|POLY-3 PERCENT (g) | 7.5% 5.0% 18.0% 24.2% |0.0% 2.4% 2.3% 2.4% |
|TERMINAL (d) | 2/20 (10%) 2/29 (7%) 8/32 (25%) 4/17 (24%) |0/29 (0%) 1/32 (3%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | 716 729 (T) 729 (T) 630 |--- 729 (T) 729 (T) 725 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012 * P=0.337N P=0.307 P=0.089 |P=0.338 P=0.520 P=0.520 P=0.471 |
|POLY 3 | P=0.012 * P=0.506N P=0.130 P=0.055 |P=0.387 P=0.507 P=0.515 P=0.502 |
|POLY 1.5 | P=0.016 * P=0.513N P=0.115 P=0.070 |P=0.389 P=0.505 P=0.512 P=0.503 |
|POLY 6 | P=0.013 * P=0.489N P=0.157 P=0.056 |P=0.378 P=0.510 P=0.518 P=0.498 |
|LOGISTIC REGRESSION| P=0.009 ** P=0.393N P=0.269 P=0.052 |P=0.346 P=0.520 P=0.520 P=0.485 |
|COCH-ARM / FISHERS | P=0.059 P=0.520N P=0.100 P=0.159 |P=0.382 P=0.505 P=0.505 P=0.500 |
|ORDER RESTRICTED | P=0.027 * (e) (e) (e) |P=0.329 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/48 (8%) 4/50 (8%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 4/40.50 4/39.75 4/45.23 2/28.31 |0/40.61 0/42.03 0/43.75 1/41.08 |
|POLY-3 PERCENT (g) | 9.9% 10.1% 8.8% 7.1% |0.0% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 0/20 (0%) 4/29 (14%) 2/32 (6%) 2/17 (12%) |0/29 (0%) 0/32 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 688 729 (T) 563 729 (T) |--- --- --- 725 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.365N P=0.461N P=0.459N P=0.459N |P=0.172 (e) (e) P=0.471 |
|POLY 3 | P=0.396N P=0.634 P=0.582N P=0.511N |P=0.198 (e) (e) P=0.502 |
|POLY 1.5 | P=0.376N P=0.627 P=0.610N P=0.473N |P=0.199 (e) (e) P=0.503 |
|POLY 6 | P=0.384N P=0.641N P=0.539N P=0.516N |P=0.195 (e) (e) P=0.498 |
|LOGISTIC REGRESSION| P=0.399N P=0.591N P=0.629N P=0.491N |P=0.181 (e) (e) P=0.485 |
|COCH-ARM / FISHERS | P=0.250N P=0.619 P=0.643N P=0.339N |P=0.197 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.554N (e) (e) (e) |P=0.122 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 6/48 (13%) 12/50 (24%) 9/50 (18%) |0/49 (0%) 1/50 (2%) 1/50 (2%) 1/49 (2%) |
|POLY-3 RATE (b) | 6/40.50 6/39.75 12/45.23 9/28.90 |0/40.61 1/42.03 1/43.75 1/41.08 |
|POLY-3 PERCENT (g) | 14.8% 15.1% 26.5% 31.1% |0.0% 2.4% 2.3% 2.4% |
|TERMINAL (d) | 2/20 (10%) 6/29 (21%) 10/32 (31%) 6/17 (35%) |0/29 (0%) 1/32 (3%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | 688 729 (T) 563 630 |--- 729 (T) 729 (T) 725 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.049 * P=0.378N P=0.357 P=0.155 |P=0.338 P=0.520 P=0.520 P=0.471 |
|POLY 3 | P=0.038 * P=0.609 P=0.142 P=0.093 |P=0.387 P=0.507 P=0.515 P=0.502 |
|POLY 1.5 | P=0.052 P=0.599 P=0.119 P=0.123 |P=0.389 P=0.505 P=0.512 P=0.503 |
|POLY 6 | P=0.040 * P=0.618N P=0.182 P=0.091 |P=0.378 P=0.510 P=0.518 P=0.498 |
|LOGISTIC REGRESSION| P=0.034 * P=0.525N P=0.182 P=0.090 |P=0.346 P=0.520 P=0.520 P=0.485 |
|COCH-ARM / FISHERS | P=0.184 P=0.591 P=0.096 P=0.288 |P=0.382 P=0.505 P=0.505 P=0.500 |
|ORDER RESTRICTED | P=0.095 (e) (e) (e) |P=0.329 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/40.18 0/41.64 0/44.41 2/28.51 |0/41.61 0/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/30 (0%) 0/32 (0%) 1/17 (6%) |0/30 (0%) 0/32 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- --- 676 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.020 * (e) (e) P=0.180 |(e) (e) (e) (e) |
|POLY 3 | P=0.038 * (e) (e) P=0.170 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.038 * (e) (e) P=0.182 |(e) (e) (e) (e) |
|POLY 6 | P=0.039 * (e) (e) P=0.171 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.022 * (e) (e) P=0.165 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Glioma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/40.18 0/41.64 0/44.41 0/28.31 |0/41.61 0/42.03 2/44.49 1/41.82 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.5% 2.4% |
|TERMINAL (d) | 0/20 (0%) 0/30 (0%) 0/32 (0%) 0/17 (0%) |0/30 (0%) 0/32 (0%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 465 456 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.235 (e) P=0.254 P=0.508 |
|POLY 3 | (e) (e) (e) (e) |P=0.248 (e) P=0.252 P=0.501 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.249 (e) P=0.248 P=0.501 |
|POLY 6 | (e) (e) (e) (e) |P=0.239 (e) P=0.257 P=0.498 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.152 (e) P=0.182 P=0.315 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.241 (e) P=0.247 P=0.495 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.180 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 1/40.18 0/41.64 0/44.41 0/28.31 |0/41.61 0/42.03 2/44.49 1/41.82 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 0.0% 0.0% |0.0% 0.0% 4.5% 2.4% |
|TERMINAL (d) | 1/20 (5%) 0/30 (0%) 0/32 (0%) 0/17 (0%) |0/30 (0%) 0/32 (0%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- 465 456 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.311N P=0.419N P=0.406N P=0.532N |P=0.235 (e) P=0.254 P=0.508 |
|POLY 3 | P=0.240N P=0.493N P=0.480N P=0.568N |P=0.248 (e) P=0.252 P=0.501 |
|POLY 1.5 | P=0.260N P=0.497N P=0.489N P=0.554N |P=0.249 (e) P=0.248 P=0.501 |
|POLY 6 | P=0.233N P=0.485N P=0.466N P=0.568N |P=0.239 (e) P=0.257 P=0.498 |
|LOGISTIC REGRESSION| P=0.311N (e) (e) (e) |P=0.152 (e) P=0.182 P=0.315 |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.241 (e) P=0.247 P=0.495 |
|ORDER RESTRICTED | P=0.193N (e) (e) (e) |P=0.180 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 4/50 (8%) |2/50 (4%) 3/49 (6%) 5/50 (10%) 2/49 (4%) |
|POLY-3 RATE (b) | 1/40.18 1/41.64 1/44.41 4/29.07 |2/41.61 3/41.03 5/44.17 2/41.28 |
|POLY-3 PERCENT (g) | 2.5% 2.4% 2.3% 13.8% |4.8% 7.3% 11.3% 4.8% |
|TERMINAL (d) | 1/20 (5%) 1/30 (3%) 1/32 (3%) 2/17 (12%) |2/30 (7%) 3/31 (10%) 4/32 (13%) 1/25 (4%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 607 |729 (T) 729 (T) 606 673 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.026 * P=0.669N P=0.654N P=0.118 |P=0.497 P=0.515 P=0.241 P=0.636 |
|POLY 3 | P=0.046 * P=0.753N P=0.738N P=0.097 |P=0.578N P=0.494 P=0.240 P=0.692 |
|POLY 1.5 | P=0.047 * P=0.757N P=0.749N P=0.110 |P=0.575N P=0.491 P=0.233 P=0.693 |
|POLY 6 | P=0.048 * P=0.744N P=0.721N P=0.100 |P=0.567 P=0.499 P=0.248 P=0.686 |
|LOGISTIC REGRESSION| P=0.026 * P=0.669N P=0.654N P=0.094 |P=0.566 P=0.515 P=0.239 P=0.679 |
|COCH-ARM / FISHERS | P=0.067 P=0.753N P=0.753N P=0.181 |P=0.573 P=0.490 P=0.218 P=0.684 |
|ORDER RESTRICTED | P=0.025 * (e) (e) (e) |P=0.438 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 6/49 (12%) 1/50 (2%) 2/49 (4%) |
|POLY-3 RATE (b) | 1/40.24 2/42.08 0/44.41 0/28.31 |2/42.17 6/41.68 1/43.75 2/41.07 |
|POLY-3 PERCENT (g) | 2.5% 4.8% 0.0% 0.0% |4.7% 14.4% 2.3% 4.9% |
|TERMINAL (d) | 0/20 (0%) 0/30 (0%) 0/32 (0%) 0/17 (0%) |1/30 (3%) 4/31 (13%) 1/32 (3%) 2/25 (8%) |
|FIRST INCIDENCE | 714 621 --- --- |556 513 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.215N P=0.573 P=0.428N P=0.560N |P=0.382N P=0.150 P=0.482N P=0.648 |
|POLY 3 | P=0.195N P=0.516 P=0.480N P=0.568N |P=0.321N P=0.127 P=0.487N P=0.685 |
|POLY 1.5 | P=0.201N P=0.507 P=0.489N P=0.554N |P=0.317N P=0.127 P=0.490N P=0.689 |
|POLY 6 | P=0.183N P=0.532 P=0.467N P=0.569N |P=0.331N P=0.130 P=0.485N P=0.674 |
|LOGISTIC REGRESSION| P=0.217N P=0.505 P=0.457N P=0.565N |P=0.319N P=0.128 P=0.507N P=0.691 |
|COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |P=0.324N P=0.128 P=0.500N P=0.684 |
|ORDER RESTRICTED | P=0.258N (e) (e) (e) |P=0.209N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 4/50 (8%) |4/50 (8%) 9/49 (18%) 6/50 (12%) 4/49 (8%) |
|POLY-3 RATE (b) | 2/40.24 3/42.08 1/44.41 4/29.07 |4/42.17 9/41.68 6/44.17 4/41.28 |
|POLY-3 PERCENT (g) | 5.0% 7.1% 2.3% 13.8% |9.5% 21.6% 13.6% 9.7% |
|TERMINAL (d) | 1/20 (5%) 1/30 (3%) 1/32 (3%) 2/17 (12%) |3/30 (10%) 7/31 (23%) 5/32 (16%) 3/25 (12%) |
|FIRST INCIDENCE | 714 621 729 (T) 607 |556 513 606 673 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.176 P=0.628 P=0.352N P=0.234 |P=0.478N P=0.132 P=0.406 P=0.563 |
|POLY 3 | P=0.220 P=0.520 P=0.466N P=0.203 |P=0.373N P=0.107 P=0.398 P=0.632 |
|POLY 1.5 | P=0.224 P=0.510 P=0.481N P=0.225 |P=0.366N P=0.107 P=0.390 P=0.637 |
|POLY 6 | P=0.232 P=0.542 P=0.442N P=0.207 |P=0.393N P=0.110 P=0.406 P=0.619 |
|LOGISTIC REGRESSION| P=0.167 P=0.527 P=0.385N P=0.195 |P=0.372N P=0.110 P=0.393 P=0.635 |
|COCH-ARM / FISHERS | P=0.292 P=0.500 P=0.500N P=0.339 |P=0.378N P=0.109 P=0.370 P=0.631 |
|ORDER RESTRICTED | P=0.126 (e) (e) (e) |P=0.350N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 12/50 (24%) 10/50 (20%) 5/50 (10%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 5/41.01 12/42.04 10/45.45 5/29.34 |0/41.61 0/42.03 0/43.75 2/41.51 |
|POLY-3 PERCENT (g) | 12.2% 28.6% 22.0% 17.0% |0.0% 0.0% 0.0% 4.8% |
|TERMINAL (d) | 2/20 (10%) 11/30 (37%) 6/32 (19%) 3/17 (18%) |0/30 (0%) 0/32 (0%) 0/32 (0%) 1/25 (4%) |
|FIRST INCIDENCE | 608 617 563 513 |--- --- --- 601 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.552 P=0.183 P=0.359 P=0.461 |P=0.039 * (e) (e) P=0.217 |
|POLY 3 | P=0.414 P=0.054 P=0.178 P=0.412 |P=0.044 * (e) (e) P=0.236 |
|POLY 1.5 | P=0.468 P=0.053 P=0.155 P=0.455 |P=0.045 * (e) (e) P=0.237 |
|POLY 6 | P=0.435 P=0.058 P=0.217 P=0.413 |P=0.043 * (e) (e) P=0.232 |
|LOGISTIC REGRESSION| P=0.483 P=0.073 P=0.156 P=0.439 |P=0.043 * (e) (e) P=0.229 |
|COCH-ARM / FISHERS | P=0.348N P=0.054 P=0.131 P=0.630N |P=0.045 * (e) (e) P=0.242 |
|ORDER RESTRICTED | P=0.236 (e) (e) (e) |P=0.029 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/40.18 1/41.64 1/44.41 0/28.31 |0/41.61 0/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 5.0% 2.4% 2.3% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/20 (10%) 1/30 (3%) 1/32 (3%) 0/17 (0%) |0/30 (0%) 0/32 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.158N P=0.359N P=0.338N P=0.273N |(e) (e) (e) (e) |
|POLY 3 | P=0.184N P=0.487N P=0.465N P=0.322N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.182N P=0.494N P=0.481N P=0.304N |(e) (e) (e) (e) |
|POLY 6 | P=0.179N P=0.474N P=0.441N P=0.322N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.158N P=0.359N P=0.338N (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.153N P=0.500N P=0.500N P=0.247N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.191N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 13/50 (26%) 11/50 (22%) 5/50 (10%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 7/41.01 13/42.04 11/45.45 5/29.34 |0/41.61 0/42.03 0/43.75 2/41.51 |
|POLY-3 PERCENT (g) | 17.1% 30.9% 24.2% 17.0% |0.0% 0.0% 0.0% 4.8% |
|TERMINAL (d) | 4/20 (20%) 12/30 (40%) 7/32 (22%) 3/17 (18%) |0/30 (0%) 0/32 (0%) 0/32 (0%) 1/25 (4%) |
|FIRST INCIDENCE | 608 617 563 513 |--- --- --- 601 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.365N P=0.327 P=0.537 P=0.556N |P=0.039 * (e) (e) P=0.217 |
|POLY 3 | P=0.484N P=0.107 P=0.291 P=0.622N |P=0.044 * (e) (e) P=0.236 |
|POLY 1.5 | P=0.436N P=0.105 P=0.256 P=0.575N |P=0.045 * (e) (e) P=0.237 |
|POLY 6 | P=0.457N P=0.116 P=0.347 P=0.621N |P=0.043 * (e) (e) P=0.232 |
|LOGISTIC REGRESSION| P=0.449N P=0.146 P=0.286 P=0.613N |P=0.043 * (e) (e) P=0.229 |
|COCH-ARM / FISHERS | P=0.192N P=0.105 P=0.218 P=0.380N |P=0.045 * (e) (e) P=0.242 |
|ORDER RESTRICTED | P=0.380 (e) (e) (e) |P=0.029 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |6/50 (12%) 1/50 (2%) 2/50 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/40.18 2/41.83 1/44.41 0/28.31 |6/42.04 1/42.03 2/43.75 1/41.07 |
|POLY-3 PERCENT (g) | 0.0% 4.8% 2.3% 0.0% |14.3% 2.4% 4.6% 2.4% |
|TERMINAL (d) | 0/20 (0%) 1/30 (3%) 1/32 (3%) 0/17 (0%) |4/30 (13%) 1/32 (3%) 2/32 (6%) 1/25 (4%) |
|FIRST INCIDENCE | --- 682 729 (T) --- |632 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.526N P=0.295 P=0.594 (e) |P=0.067N P=0.052N P=0.117N P=0.090N |
|POLY 3 | P=0.550N P=0.246 P=0.520 (e) |P=0.049N* P=0.055N P=0.119N P=0.058N |
|POLY 1.5 | P=0.539N P=0.241 P=0.511 (e) |P=0.048N* P=0.056N P=0.123N P=0.057N |
|POLY 6 | P=0.538N P=0.256 P=0.534 (e) |P=0.051N P=0.053N P=0.117N P=0.063N |
|LOGISTIC REGRESSION| P=0.542N P=0.253 P=0.594 (e) |P=0.052N P=0.054N P=0.114N P=0.063N |
|COCH-ARM / FISHERS | P=0.461N P=0.247 P=0.500 (e) |P=0.052N P=0.056N P=0.134N P=0.059N |
|ORDER RESTRICTED | P=0.381 (e) (e) (e) |P=0.014N* (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/40.24 2/41.64 0/44.41 0/28.31 |0/41.61 1/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 2.5% 4.8% 0.0% 0.0% |0.0% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 2/30 (7%) 0/32 (0%) 0/17 (0%) |0/30 (0%) 1/32 (3%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 714 729 (T) --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.202N P=0.627 P=0.428N P=0.560N |P=0.599N P=0.513 (e) (e) |
|POLY 3 | P=0.196N P=0.512 P=0.480N P=0.568N |P=0.566N P=0.502 (e) (e) |
|POLY 1.5 | P=0.202N P=0.506 P=0.489N P=0.554N |P=0.567N P=0.501 (e) (e) |
|POLY 6 | P=0.183N P=0.525 P=0.467N P=0.569N |P=0.563N P=0.505 (e) (e) |
|LOGISTIC REGRESSION| P=0.212N P=0.578 P=0.457N P=0.565N |(e) P=0.513 (e) (e) |
|COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |P=0.571N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.256N (e) (e) (e) |P=0.385N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |4/50 (8%) 0/50 (0%) 2/50 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/40.18 0/41.64 1/44.72 0/28.31 |4/41.69 0/42.03 2/43.91 0/41.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 0.0% |9.6% 0.0% 4.6% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/30 (0%) 0/32 (0%) 0/17 (0%) |3/30 (10%) 0/32 (0%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- 645 --- |710 --- 686 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.670 (e) P=0.550 (e) |P=0.074N P=0.056N P=0.305N P=0.089N |
|POLY 3 | P=0.495 (e) P=0.521 (e) |P=0.060N P=0.059N P=0.313N P=0.061N |
|POLY 1.5 | P=0.546 (e) P=0.511 (e) |P=0.060N P=0.060N P=0.320N P=0.061N |
|POLY 6 | P=0.479 (e) P=0.536 (e) |P=0.063N P=0.057N P=0.305N P=0.064N |
|LOGISTIC REGRESSION| P=0.709 (e) P=0.468 (e) |P=0.063N P=0.055N P=0.304N P=0.074N |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.063N P=0.059N P=0.339N P=0.061N |
|ORDER RESTRICTED | P=0.416 (e) (e) (e) |P=0.012N* (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |4/50 (8%) 1/50 (2%) 2/50 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/40.18 0/41.64 1/44.72 0/28.31 |4/41.69 1/42.23 2/43.91 1/41.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 0.0% |9.6% 2.4% 4.6% 2.4% |
|TERMINAL (d) | 0/20 (0%) 0/30 (0%) 0/32 (0%) 0/17 (0%) |3/30 (10%) 0/32 (0%) 1/32 (3%) 1/25 (4%) |
|FIRST INCIDENCE | --- --- 645 --- |710 677 686 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.670 (e) P=0.550 (e) |P=0.201N P=0.162N P=0.305N P=0.238N |
|POLY 3 | P=0.495 (e) P=0.521 (e) |P=0.167N P=0.174N P=0.313N P=0.182N |
|POLY 1.5 | P=0.546 (e) P=0.511 (e) |P=0.166N P=0.177N P=0.320N P=0.180N |
|POLY 6 | P=0.479 (e) P=0.536 (e) |P=0.173N P=0.168N P=0.305N P=0.189N |
|LOGISTIC REGRESSION| P=0.709 (e) P=0.468 (e) |P=0.170N P=0.171N P=0.304N P=0.209N |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.169N P=0.181N P=0.339N P=0.187N |
|ORDER RESTRICTED | P=0.416 (e) (e) (e) |P=0.098N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 1/50 (2%) 1/50 (2%) |12/50 (24%) 11/50 (22%) 21/50 (42%) 16/49 (33%) |
|POLY-3 RATE (b) | 0/40.18 4/41.83 1/44.41 1/28.31 |12/42.74 11/42.03 21/45.13 16/42.85 |
|POLY-3 PERCENT (g) | 0.0% 9.6% 2.3% 3.5% |28.1% 26.2% 46.5% 37.3% |
|TERMINAL (d) | 0/20 (0%) 3/30 (10%) 1/32 (3%) 1/17 (6%) |8/30 (27%) 10/32 (31%) 17/32 (53%) 9/25 (36%) |
|FIRST INCIDENCE | --- 682 729 (T) 729 (T) |606 728 465 559 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.597 P=0.113 P=0.594 P=0.468 |P=0.044 * P=0.441N P=0.073 P=0.154 |
|POLY 3 | P=0.509 P=0.065 P=0.520 P=0.432 |P=0.124 P=0.519N P=0.055 P=0.245 |
|POLY 1.5 | P=0.534 P=0.062 P=0.511 P=0.446 |P=0.125 P=0.512N P=0.052 P=0.248 |
|POLY 6 | P=0.523 P=0.070 P=0.534 P=0.432 |P=0.113 P=0.526N P=0.055 P=0.231 |
|LOGISTIC REGRESSION| P=0.572 P=0.078 P=0.594 P=0.468 |P=0.106 P=0.475N P=0.059 P=0.235 |
|COCH-ARM / FISHERS | P=0.556N P=0.059 P=0.500 P=0.500 |P=0.111 P=0.500N P=0.044 * P=0.232 |
|ORDER RESTRICTED | P=0.245 (e) (e) (e) |P=0.106 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 1/50 (2%) 1/50 (2%) |12/50 (24%) 12/50 (24%) 21/50 (42%) 16/49 (33%) |
|POLY-3 RATE (b) | 0/40.18 4/41.83 1/44.41 1/28.31 |12/42.74 12/42.23 21/45.13 16/42.85 |
|POLY-3 PERCENT (g) | 0.0% 9.6% 2.3% 3.5% |28.1% 28.4% 46.5% 37.3% |
|TERMINAL (d) | 0/20 (0%) 3/30 (10%) 1/32 (3%) 1/17 (6%) |8/30 (27%) 10/32 (31%) 17/32 (53%) 9/25 (36%) |
|FIRST INCIDENCE | --- 682 729 (T) 729 (T) |606 677 465 559 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.597 P=0.113 P=0.594 P=0.468 |P=0.053 P=0.530N P=0.073 P=0.154 |
|POLY 3 | P=0.509 P=0.065 P=0.520 P=0.432 |P=0.142 P=0.582 P=0.055 P=0.245 |
|POLY 1.5 | P=0.534 P=0.062 P=0.511 P=0.446 |P=0.143 P=0.585 P=0.052 P=0.248 |
|POLY 6 | P=0.523 P=0.070 P=0.534 P=0.432 |P=0.129 P=0.581 P=0.055 P=0.231 |
|LOGISTIC REGRESSION| P=0.572 P=0.078 P=0.594 P=0.468 |P=0.123 P=0.573N P=0.059 P=0.235 |
|COCH-ARM / FISHERS | P=0.556N P=0.059 P=0.500 P=0.500 |P=0.127 P=0.592N P=0.044 * P=0.232 |
|ORDER RESTRICTED | P=0.245 (e) (e) (e) |P=0.131 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 2/50 (4%) 1/50 (2%) |14/50 (28%) 12/50 (24%) 22/50 (44%) 16/49 (33%) |
|POLY-3 RATE (b) | 0/40.18 4/41.83 2/44.72 1/28.31 |14/42.81 12/42.23 22/45.29 16/42.85 |
|POLY-3 PERCENT (g) | 0.0% 9.6% 4.5% 3.5% |32.7% 28.4% 48.6% 37.3% |
|TERMINAL (d) | 0/20 (0%) 3/30 (10%) 1/32 (3%) 1/17 (6%) |9/30 (30%) 10/32 (31%) 17/32 (53%) 9/25 (36%) |
|FIRST INCIDENCE | --- 682 645 729 (T) |606 677 465 559 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.541 P=0.113 P=0.321 P=0.468 |P=0.103 P=0.350N P=0.123 P=0.268 |
|POLY 3 | P=0.432 P=0.065 P=0.262 P=0.432 |P=0.239 P=0.423N P=0.093 P=0.411 |
|POLY 1.5 | P=0.466 P=0.062 P=0.250 P=0.446 |P=0.240 P=0.418N P=0.087 P=0.413 |
|POLY 6 | P=0.443 P=0.070 P=0.280 P=0.432 |P=0.222 P=0.427N P=0.096 P=0.393 |
|LOGISTIC REGRESSION| P=0.509 P=0.078 P=0.239 P=0.468 |P=0.211 P=0.383N P=0.095 P=0.393 |
|COCH-ARM / FISHERS | P=0.577N P=0.059 P=0.247 P=0.500 |P=0.213 P=0.410N P=0.072 P=0.388 |
|ORDER RESTRICTED | P=0.214 (e) (e) (e) |P=0.172 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Papilloma Squamous or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/40.18 0/41.64 1/44.41 0/28.31 |2/41.61 0/42.03 1/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 0.0% |4.8% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/30 (0%) 1/32 (3%) 0/17 (0%) |2/30 (7%) 0/32 (0%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.689 (e) P=0.594 (e) |P=0.212N P=0.224N P=0.477N P=0.279N |
|POLY 3 | P=0.496 (e) P=0.520 (e) |P=0.190N P=0.235N P=0.483N P=0.240N |
|POLY 1.5 | P=0.547 (e) P=0.511 (e) |P=0.189N P=0.236N P=0.488N P=0.238N |
|POLY 6 | P=0.481 (e) P=0.534 (e) |P=0.193N P=0.231N P=0.478N P=0.245N |
|LOGISTIC REGRESSION| (e) (e) P=0.594 (e) |P=0.212N (e) P=0.477N (e) |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.191N P=0.247N P=0.500N P=0.253N |
|ORDER RESTRICTED | P=0.415 (e) (e) (e) |P=0.076N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/40.18 0/41.64 2/44.85 0/28.31 |1/42.46 0/42.03 1/43.90 0/41.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 0.0% |2.4% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/30 (0%) 0/32 (0%) 0/17 (0%) |0/30 (0%) 0/32 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- 645 --- |394 --- 690 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.537 (e) P=0.302 (e) |P=0.406N P=0.504N P=0.745N P=0.496N |
|POLY 3 | P=0.357 (e) P=0.262 (e) |P=0.409N P=0.502N P=0.753N P=0.507N |
|POLY 1.5 | P=0.413 (e) P=0.251 (e) |P=0.407N P=0.502N P=0.755N P=0.504N |
|POLY 6 | P=0.341 (e) P=0.281 (e) |P=0.414N P=0.500N P=0.751N P=0.512N |
|LOGISTIC REGRESSION| P=0.564 (e) P=0.220 (e) |P=0.498N P=0.487N P=0.681 P=0.783N |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.409N P=0.500N P=0.753N P=0.505N |
|ORDER RESTRICTED | P=0.290 (e) (e) (e) |P=0.257N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|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%) 3/50 (6%) 0/50 (0%) |3/50 (6%) 0/50 (0%) 2/50 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/40.18 0/41.64 3/44.85 0/28.31 |3/42.46 0/42.03 2/43.90 0/41.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.7% 0.0% |7.1% 0.0% 4.6% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/30 (0%) 1/32 (3%) 0/17 (0%) |2/30 (7%) 0/32 (0%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- 645 --- |394 --- 690 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.467 (e) P=0.190 (e) |P=0.141N P=0.116N P=0.470N P=0.143N |
|POLY 3 | P=0.275 (e) P=0.139 (e) |P=0.127N P=0.120N P=0.485N P=0.124N |
|POLY 1.5 | P=0.333 (e) P=0.130 (e) |P=0.125N P=0.120N P=0.489N P=0.122N |
|POLY 6 | P=0.260 (e) P=0.156 (e) |P=0.131N P=0.118N P=0.479N P=0.129N |
|LOGISTIC REGRESSION| P=0.467 (e) P=0.123 (e) |P=0.135N P=0.119N P=0.528N P=0.140N |
|COCH-ARM / FISHERS | P=0.539 (e) P=0.121 (e) |P=0.128N P=0.121N P=0.500N P=0.125N |
|ORDER RESTRICTED | P=0.206 (e) (e) (e) |P=0.039N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/40.18 0/41.64 2/44.85 0/28.31 |1/42.46 0/42.03 1/43.90 0/41.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 0.0% |2.4% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/30 (0%) 0/32 (0%) 0/17 (0%) |0/30 (0%) 0/32 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- 645 --- |394 --- 690 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.537 (e) P=0.302 (e) |P=0.406N P=0.504N P=0.745N P=0.496N |
|POLY 3 | P=0.357 (e) P=0.262 (e) |P=0.409N P=0.502N P=0.753N P=0.507N |
|POLY 1.5 | P=0.413 (e) P=0.251 (e) |P=0.407N P=0.502N P=0.755N P=0.504N |
|POLY 6 | P=0.341 (e) P=0.281 (e) |P=0.414N P=0.500N P=0.751N P=0.512N |
|LOGISTIC REGRESSION| P=0.564 (e) P=0.220 (e) |P=0.498N P=0.487N P=0.681 P=0.783N |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.409N P=0.500N P=0.753N P=0.505N |
|ORDER RESTRICTED | P=0.290 (e) (e) (e) |P=0.257N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/40.18 1/41.64 2/44.95 0/28.31 |0/41.61 0/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 7.5% 2.4% 4.5% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/20 (15%) 1/30 (3%) 1/32 (3%) 0/17 (0%) |0/30 (0%) 0/32 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 563 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.117N P=0.172N P=0.327N P=0.148N |(e) (e) (e) (e) |
|POLY 3 | P=0.150N P=0.292N P=0.449N P=0.194N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.144N P=0.299N P=0.472N P=0.176N |(e) (e) (e) (e) |
|POLY 6 | P=0.147N P=0.277N P=0.414N P=0.193N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.142N P=0.172N P=0.465N (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.104N P=0.309N P=0.500N P=0.121N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.115N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 33/50 (66%) 42/50 (84%) 20/50 (40%) |33/50 (66%) 34/50 (68%) 33/50 (66%) 27/49 (55%) |
|POLY-3 RATE (b) | 29/45.46 33/47.21 42/49.46 20/31.56 |33/44.47 34/46.41 33/47.67 27/43.85 |
|POLY-3 PERCENT (g) | 63.8% 69.9% 84.9% 63.4% |74.2% 73.3% 69.2% 61.6% |
|TERMINAL (d) | 14/20 (70%) 19/30 (63%) 27/32 (84%) 12/17 (71%) |24/30 (80%) 22/32 (69%) 22/32 (69%) 17/25 (68%) |
|FIRST INCIDENCE | 522 444 444 290 |437 522 465 469 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.435N P=0.355N P=0.498 P=0.370N |P=0.383N P=0.522N P=0.419N P=0.443N |
|POLY 3 | P=0.262 P=0.338 P=0.011 * P=0.582N |P=0.090N P=0.555N P=0.379N P=0.135N |
|POLY 1.5 | P=0.475 P=0.301 P=0.006 ** P=0.402N |P=0.086N P=0.569 P=0.449N P=0.139N |
|POLY 6 | P=0.229 P=0.416 P=0.026 * P=0.572 |P=0.117N P=0.454N P=0.309N P=0.148N |
|LOGISTIC REGRESSION| P=0.441N P=0.274 P=0.005 ** P=0.467N |P=0.088N P=0.506 P=0.487N P=0.147N |
|COCH-ARM / FISHERS | P=0.031N* P=0.268 P=0.004 ** P=0.055N |P=0.119N P=0.500 P=0.583N P=0.183N |
|ORDER RESTRICTED | P=0.186 (e) (e) (e) |P=0.146N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |3/50 (6%) 1/50 (2%) 1/50 (2%) 4/49 (8%) |
|POLY-3 RATE (b) | 5/41.63 1/42.23 0/44.41 2/28.31 |3/42.21 1/42.10 1/43.75 4/42.10 |
|POLY-3 PERCENT (g) | 12.0% 2.4% 0.0% 7.1% |7.1% 2.4% 2.3% 9.5% |
|TERMINAL (d) | 1/20 (5%) 0/30 (0%) 0/32 (0%) 2/17 (12%) |1/30 (3%) 0/32 (0%) 1/32 (3%) 1/25 (4%) |
|FIRST INCIDENCE | 463 542 --- 729 (T) |626 712 729 (T) 593 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.232N P=0.080N P=0.020N* P=0.347N |P=0.264 P=0.294N P=0.286N P=0.460 |
|POLY 3 | P=0.143N P=0.097N P=0.025N* P=0.397N |P=0.300 P=0.306N P=0.292N P=0.498 |
|POLY 1.5 | P=0.156N P=0.100N P=0.028N* P=0.353N |P=0.301 P=0.306N P=0.295N P=0.500 |
|POLY 6 | P=0.133N P=0.090N P=0.021N* P=0.408N |P=0.294 P=0.304N P=0.291N P=0.490 |
|LOGISTIC REGRESSION| P=0.149N P=0.105N P=0.049N* P=0.323N |P=0.292 P=0.304N P=0.299N P=0.480 |
|COCH-ARM / FISHERS | P=0.165N P=0.102N P=0.028N* P=0.218N |P=0.293 P=0.309N P=0.309N P=0.489 |
|ORDER RESTRICTED | P=0.079N (e) (e) (e) |P=0.198 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 34/50 (68%) 42/50 (84%) 22/50 (44%) |36/50 (72%) 35/50 (70%) 34/50 (68%) 30/49 (61%) |
|POLY-3 RATE (b) | 34/46.91 34/47.80 42/49.46 22/31.56 |36/45.07 35/46.48 34/47.67 30/44.75 |
|POLY-3 PERCENT (g) | 72.5% 71.1% 84.9% 69.7% |79.9% 75.3% 71.3% 67.0% |
|TERMINAL (d) | 15/20 (75%) 19/30 (63%) 27/32 (84%) 14/17 (82%) |25/30 (83%) 22/32 (69%) 23/32 (72%) 18/25 (72%) |
|FIRST INCIDENCE | 463 444 444 290 |437 522 465 469 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.315N P=0.155N P=0.292N P=0.250N |P=0.432N P=0.383N P=0.284N P=0.462N |
|POLY 3 | P=0.376 P=0.534N P=0.095 P=0.496N |P=0.090N P=0.389N P=0.229N P=0.113N |
|POLY 1.5 | P=0.434N P=0.564N P=0.070 P=0.265N |P=0.090N P=0.446N P=0.282N P=0.122N |
|POLY 6 | P=0.299 P=0.468N P=0.150 P=0.603N |P=0.114N P=0.308N P=0.189N P=0.123N |
|LOGISTIC REGRESSION| P=0.252N P=0.573 P=0.042 * P=0.298N |P=0.099N P=0.496N P=0.309N P=0.134N |
|COCH-ARM / FISHERS | P=0.008N** P=0.585N P=0.050 P=0.013N* |P=0.135N P=0.500N P=0.414N P=0.178N |
|ORDER RESTRICTED | P=0.388 (e) (e) (e) |P=0.122N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/41.05 0/41.64 0/44.41 0/28.31 |0/41.61 1/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 4.9% 0.0% 0.0% 0.0% |0.0% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/30 (0%) 0/32 (0%) 0/17 (0%) |0/30 (0%) 1/32 (3%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 533 --- --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.136N P=0.242N P=0.222N P=0.333N |P=0.599N P=0.513 (e) (e) |
|POLY 3 | P=0.086N P=0.234N P=0.220N P=0.328N |P=0.566N P=0.502 (e) (e) |
|POLY 1.5 | P=0.095N P=0.236N P=0.228N P=0.307N |P=0.567N P=0.501 (e) (e) |
|POLY 6 | P=0.081N P=0.228N P=0.208N P=0.332N |P=0.563N P=0.505 (e) (e) |
|LOGISTIC REGRESSION| P=0.056N P=0.236N P=0.296N P=0.205N |(e) P=0.513 (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.571N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.078N (e) (e) (e) |P=0.385N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/41.05 0/41.64 0/44.41 0/28.31 |0/41.61 1/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 7.3% 0.0% 0.0% 0.0% |0.0% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/30 (0%) 0/32 (0%) 0/17 (0%) |0/30 (0%) 1/32 (3%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 533 --- --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.053N P=0.102N P=0.089N P=0.187N |P=0.599N P=0.513 (e) (e) |
|POLY 3 | P=0.033N* P=0.115N P=0.105N P=0.199N |P=0.566N P=0.502 (e) (e) |
|POLY 1.5 | P=0.038N* P=0.118N P=0.111N P=0.179N |P=0.567N P=0.501 (e) (e) |
|POLY 6 | P=0.031N* P=0.111N P=0.096N P=0.203N |P=0.563N P=0.505 (e) (e) |
|LOGISTIC REGRESSION| P=0.033N* P=0.124N P=0.150N P=0.139N |(e) P=0.513 (e) (e) |
|COCH-ARM / FISHERS | P=0.047N* P=0.121N P=0.121N P=0.121N |P=0.571N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.030N* (e) (e) (e) |P=0.385N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |
|POLY-3 RATE (b) | 1/40.18 2/41.64 1/44.41 0/28.31 | |
|POLY-3 PERCENT (g) | 2.5% 4.8% 2.3% 0.0% | |
|TERMINAL (d) | 1/20 (5%) 2/30 (7%) 1/32 (3%) 0/17 (0%) | |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.272N P=0.641 P=0.654N P=0.532N | |
|POLY 3 | P=0.312N P=0.513 P=0.738N P=0.568N | |
|POLY 1.5 | P=0.305N P=0.506 P=0.749N P=0.554N | |
|POLY 6 | P=0.301N P=0.526 P=0.721N P=0.568N | |
|LOGISTIC REGRESSION| P=0.272N P=0.641 P=0.654N (e) | |
|COCH-ARM / FISHERS | P=0.247N P=0.500 P=0.753N P=0.500N | |
|ORDER RESTRICTED | P=0.311N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|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) | 4/50 (8%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 4/40.64 2/41.64 4/44.41 1/28.31 |1/41.61 0/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 9.8% 4.8% 9.0% 3.5% |2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 2/30 (7%) 4/32 (13%) 1/17 (6%) |1/30 (3%) 0/32 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 662 729 (T) 729 (T) 729 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.249N P=0.224N P=0.421N P=0.272N |P=0.323N P=0.487N P=0.487N P=0.536N |
|POLY 3 | P=0.314N P=0.325N P=0.594N P=0.307N |P=0.307N P=0.498N P=0.490N P=0.503N |
|POLY 1.5 | P=0.291N P=0.332N P=0.617N P=0.276N |P=0.308N P=0.499N P=0.493N P=0.501N |
|POLY 6 | P=0.313N P=0.312N P=0.561N P=0.311N |P=0.304N P=0.495N P=0.487N P=0.507N |
|LOGISTIC REGRESSION| P=0.278N P=0.296N P=0.526N P=0.293N |P=0.323N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.186N P=0.339N P=0.643N P=0.181N |P=0.308N P=0.500N P=0.500N P=0.505N |
|ORDER RESTRICTED | P=0.285N (e) (e) (e) |P=0.122N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 3/49 (6%) |
|POLY-3 RATE (b) | 5/40.89 4/41.83 2/44.41 3/29.23 |0/41.61 0/42.03 1/43.75 3/41.55 |
|POLY-3 PERCENT (g) | 12.2% 9.6% 4.5% 10.3% |0.0% 0.0% 2.3% 7.2% |
|TERMINAL (d) | 2/20 (10%) 3/30 (10%) 2/32 (6%) 0/17 (0%) |0/30 (0%) 0/32 (0%) 1/32 (3%) 1/25 (4%) |
|FIRST INCIDENCE | 608 682 729 (T) 606 |--- --- 729 (T) 662 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.367N P=0.342N P=0.102N P=0.511N |P=0.015 * (e) P=0.513 P=0.110 |
|POLY 3 | P=0.330N P=0.486N P=0.183N P=0.549N |P=0.019 * (e) P=0.510 P=0.118 |
|POLY 1.5 | P=0.328N P=0.494N P=0.198N P=0.511N |P=0.019 * (e) P=0.507 P=0.118 |
|POLY 6 | P=0.315N P=0.468N P=0.162N P=0.543N |P=0.018 * (e) P=0.513 P=0.115 |
|LOGISTIC REGRESSION| P=0.393N P=0.463N P=0.171N P=0.520N |P=0.019 * (e) P=0.513 P=0.118 |
|COCH-ARM / FISHERS | P=0.256N P=0.500N P=0.218N P=0.357N |P=0.019 * (e) P=0.500 P=0.117 |
|ORDER RESTRICTED | P=0.372N (e) (e) (e) |P=0.020 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 3/50 (6%) 3/50 (6%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 3/49 (6%) |
|POLY-3 RATE (b) | 5/40.89 4/41.83 3/44.70 3/29.23 |0/41.61 2/42.13 1/43.75 3/41.55 |
|POLY-3 PERCENT (g) | 12.2% 9.6% 6.7% 10.3% |0.0% 4.8% 2.3% 7.2% |
|TERMINAL (d) | 2/20 (10%) 3/30 (10%) 2/32 (6%) 0/17 (0%) |0/30 (0%) 1/32 (3%) 1/32 (3%) 1/25 (4%) |
|FIRST INCIDENCE | 608 682 649 606 |--- 703 729 (T) 662 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.404N P=0.342N P=0.195N P=0.511N |P=0.080 P=0.257 P=0.513 P=0.110 |
|POLY 3 | P=0.382N P=0.486N P=0.308N P=0.549N |P=0.103 P=0.240 P=0.510 P=0.118 |
|POLY 1.5 | P=0.374N P=0.494N P=0.330N P=0.511N |P=0.103 P=0.238 P=0.507 P=0.118 |
|POLY 6 | P=0.366N P=0.468N P=0.276N P=0.543N |P=0.100 P=0.243 P=0.513 P=0.115 |
|LOGISTIC REGRESSION| P=0.421N P=0.463N P=0.318N P=0.520N |P=0.099 P=0.243 P=0.513 P=0.118 |
|COCH-ARM / FISHERS | P=0.278N P=0.500N P=0.357N P=0.357N |P=0.099 P=0.247 P=0.500 P=0.117 |
|ORDER RESTRICTED | P=0.470N (e) (e) (e) |P=0.056 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/40.18 0/41.64 1/44.70 0/28.31 |0/41.61 2/42.13 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 0.0% |0.0% 4.8% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/30 (0%) 0/32 (0%) 0/17 (0%) |0/30 (0%) 1/32 (3%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- 649 --- |--- 703 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.667 (e) P=0.541 (e) |P=0.434N P=0.257 (e) (e) |
|POLY 3 | P=0.495 (e) P=0.521 (e) |P=0.402N P=0.240 (e) (e) |
|POLY 1.5 | P=0.546 (e) P=0.511 (e) |P=0.403N P=0.238 (e) (e) |
|POLY 6 | P=0.479 (e) P=0.536 (e) |P=0.402N P=0.243 (e) (e) |
|LOGISTIC REGRESSION| P=0.704 (e) P=0.470 (e) |P=0.413N P=0.243 (e) (e) |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.409N P=0.247 (e) (e) |
|ORDER RESTRICTED | P=0.416 (e) (e) (e) |P=0.252N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/40.48 1/41.64 3/44.41 1/28.31 |1/41.61 0/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 7.4% 2.4% 6.8% 3.5% |2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 1/30 (3%) 3/32 (9%) 1/17 (6%) |1/30 (3%) 0/32 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 662 729 (T) 729 (T) 729 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.390N P=0.210N P=0.465N P=0.393N |P=0.323N P=0.487N P=0.487N P=0.536N |
|POLY 3 | P=0.430N P=0.294N P=0.619N P=0.441N |P=0.307N P=0.498N P=0.490N P=0.503N |
|POLY 1.5 | P=0.411N P=0.300N P=0.639N P=0.411N |P=0.308N P=0.499N P=0.493N P=0.501N |
|POLY 6 | P=0.428N P=0.283N P=0.589N P=0.444N |P=0.304N P=0.495N P=0.487N P=0.507N |
|LOGISTIC REGRESSION| P=0.420N P=0.272N P=0.556N P=0.430N |P=0.323N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.313N P=0.309N P=0.661N P=0.309N |P=0.308N P=0.500N P=0.500N P=0.505N |
|ORDER RESTRICTED | P=0.407N (e) (e) (e) |P=0.122N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Lipoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/40.18 3/41.64 1/44.41 0/28.31 |0/41.61 0/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 0.0% 7.2% 2.3% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 3/30 (10%) 1/32 (3%) 0/17 (0%) |0/30 (0%) 0/32 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.415N P=0.200 P=0.594 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.466N P=0.124 P=0.520 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.454N P=0.121 P=0.511 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.450N P=0.131 P=0.534 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.200 P=0.594 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.366N P=0.121 P=0.500 (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.306N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Schwannoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/40.60 0/41.64 2/44.41 2/28.31 |2/41.89 0/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 4.9% 0.0% 4.5% 7.1% |4.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/30 (0%) 2/32 (6%) 2/17 (12%) |1/30 (3%) 0/32 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 606 --- 729 (T) 729 (T) |654 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.352 P=0.201N P=0.549N P=0.624 |P=0.120N P=0.233N P=0.227N P=0.263N |
|POLY 3 | P=0.326 P=0.231N P=0.662N P=0.557 |P=0.113N P=0.236N P=0.227N P=0.241N |
|POLY 1.5 | P=0.346 P=0.234N P=0.676N P=0.588 |P=0.114N P=0.237N P=0.230N P=0.239N |
|POLY 6 | P=0.323 P=0.224N P=0.638N P=0.554 |P=0.112N P=0.234N P=0.225N P=0.247N |
|LOGISTIC REGRESSION| P=0.321 P=0.239N P=0.665N P=0.567 |P=0.115N P=0.237N P=0.232N P=0.240N |
|COCH-ARM / FISHERS | P=0.444 P=0.247N P=0.691N P=0.691N |P=0.116N P=0.247N P=0.247N P=0.253N |
|ORDER RESTRICTED | P=0.294 (e) (e) (e) |P=0.031N* (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 4/40.64 2/41.64 4/44.41 1/28.31 |1/41.61 0/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 9.8% 4.8% 9.0% 3.5% |2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 2/30 (7%) 4/32 (13%) 1/17 (6%) |1/30 (3%) 0/32 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 662 729 (T) 729 (T) 729 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.249N P=0.224N P=0.421N P=0.272N |P=0.323N P=0.487N P=0.487N P=0.536N |
|POLY 3 | P=0.314N P=0.325N P=0.594N P=0.307N |P=0.307N P=0.498N P=0.490N P=0.503N |
|POLY 1.5 | P=0.291N P=0.332N P=0.617N P=0.276N |P=0.308N P=0.499N P=0.493N P=0.501N |
|POLY 6 | P=0.313N P=0.312N P=0.561N P=0.311N |P=0.304N P=0.495N P=0.487N P=0.507N |
|LOGISTIC REGRESSION| P=0.278N P=0.296N P=0.526N P=0.293N |P=0.323N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.186N P=0.339N P=0.643N P=0.181N |P=0.308N P=0.500N P=0.500N P=0.505N |
|ORDER RESTRICTED | P=0.285N (e) (e) (e) |P=0.122N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 4/40.64 2/41.64 4/44.41 1/28.31 |1/41.61 0/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 9.8% 4.8% 9.0% 3.5% |2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 2/30 (7%) 4/32 (13%) 1/17 (6%) |1/30 (3%) 0/32 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 662 729 (T) 729 (T) 729 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.249N P=0.224N P=0.421N P=0.272N |P=0.323N P=0.487N P=0.487N P=0.536N |
|POLY 3 | P=0.314N P=0.325N P=0.594N P=0.307N |P=0.307N P=0.498N P=0.490N P=0.503N |
|POLY 1.5 | P=0.291N P=0.332N P=0.617N P=0.276N |P=0.308N P=0.499N P=0.493N P=0.501N |
|POLY 6 | P=0.313N P=0.312N P=0.561N P=0.311N |P=0.304N P=0.495N P=0.487N P=0.507N |
|LOGISTIC REGRESSION| P=0.278N P=0.296N P=0.526N P=0.293N |P=0.323N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.186N P=0.339N P=0.643N P=0.181N |P=0.308N P=0.500N P=0.500N P=0.505N |
|ORDER RESTRICTED | P=0.285N (e) (e) (e) |P=0.122N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 36/50 (72%) 37/50 (74%) 31/50 (62%) 22/50 (44%) | |
|POLY-3 RATE (b) | 36/45.13 37/44.91 31/46.60 22/30.15 | |
|POLY-3 PERCENT (g) | 79.8% 82.4% 66.5% 73.0% | |
|TERMINAL (d) | 18/20 (90%) 26/30 (87%) 22/32 (69%) 15/17 (88%) | |
|FIRST INCIDENCE | 533 571 444 606 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.060N P=0.087N P=0.003N** P=0.123N | |
|POLY 3 | P=0.111N P=0.479 P=0.101N P=0.330N | |
|POLY 1.5 | P=0.051N P=0.483 P=0.137N P=0.134N | |
|POLY 6 | P=0.124N P=0.497 P=0.069N P=0.444N | |
|LOGISTIC REGRESSION| P=0.106N P=0.583 P=0.062N P=0.256N | |
|COCH-ARM / FISHERS | P<0.001N** P=0.500 P=0.198N P=0.004N** | |
|ORDER RESTRICTED | P=0.182N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 9/50 (18%) 8/50 (16%) 4/50 (8%) |3/50 (6%) 2/50 (4%) 6/50 (12%) 6/49 (12%) |
|POLY-3 RATE (b) | 5/40.29 9/43.03 8/44.95 4/28.73 |3/41.61 2/42.13 6/43.92 6/41.99 |
|POLY-3 PERCENT (g) | 12.4% 20.9% 17.8% 13.9% |7.2% 4.8% 13.7% 14.3% |
|TERMINAL (d) | 4/20 (20%) 4/30 (13%) 5/32 (16%) 3/17 (18%) |3/30 (10%) 1/32 (3%) 4/32 (13%) 3/25 (12%) |
|FIRST INCIDENCE | 701 593 645 607 |729 (T) 703 703 593 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491N P=0.380 P=0.580 P=0.620N |P=0.065 P=0.469N P=0.278 P=0.186 |
|POLY 3 | P=0.508 P=0.227 P=0.349 P=0.569 |P=0.107 P=0.494N P=0.268 P=0.245 |
|POLY 1.5 | P=0.535N P=0.209 P=0.314 P=0.609 |P=0.107 P=0.498N P=0.260 P=0.244 |
|POLY 6 | P=0.526 P=0.266 P=0.406 P=0.575 |P=0.102 P=0.487N P=0.277 P=0.241 |
|LOGISTIC REGRESSION| P=0.555N P=0.219 P=0.435 P=0.577 |P=0.095 P=0.475N P=0.279 P=0.233 |
|COCH-ARM / FISHERS | P=0.309N P=0.194 P=0.277 P=0.500N |P=0.100 P=0.500N P=0.243 P=0.233 |
|ORDER RESTRICTED | P=0.454 (e) (e) (e) |P=0.160 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 22
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 2/50 (4%) 3/49 (6%) |
|POLY-3 RATE (b) | 5/40.69 1/41.64 2/44.41 0/28.31 |2/41.79 0/42.03 2/43.75 3/41.89 |
|POLY-3 PERCENT (g) | 12.3% 2.4% 4.5% 0.0% |4.8% 0.0% 4.6% 7.2% |
|TERMINAL (d) | 3/20 (15%) 1/30 (3%) 2/32 (6%) 0/17 (0%) |1/30 (3%) 0/32 (0%) 2/32 (6%) 0/25 (0%) |
|FIRST INCIDENCE | 593 729 (T) 729 (T) --- |682 --- 729 (T) 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.026N* P=0.046N* P=0.089N P=0.057N |P=0.203 P=0.226N P=0.662N P=0.471 |
|POLY 3 | P=0.038N* P=0.094N P=0.181N P=0.075N |P=0.236 P=0.236N P=0.678N P=0.501 |
|POLY 1.5 | P=0.036N* P=0.098N P=0.197N P=0.063N |P=0.237 P=0.237N P=0.682N P=0.501 |
|POLY 6 | P=0.036N* P=0.087N P=0.159N P=0.076N |P=0.231 P=0.233N P=0.675N P=0.496 |
|LOGISTIC REGRESSION| P=0.036N* P=0.087N P=0.153N P=0.069N |P=0.233 P=0.235N P=0.672N P=0.490 |
|COCH-ARM / FISHERS | P=0.025N* P=0.102N P=0.218N P=0.028N* |P=0.230 P=0.247N P=0.691N P=0.490 |
|ORDER RESTRICTED | P=0.024N* (e) (e) (e) |P=0.216 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 10/50 (20%) 9/50 (18%) 4/50 (8%) |5/50 (10%) 2/50 (4%) 8/50 (16%) 9/49 (18%) |
|POLY-3 RATE (b) | 10/40.80 10/43.03 9/44.95 4/28.73 |5/41.79 2/42.13 8/43.92 9/42.81 |
|POLY-3 PERCENT (g) | 24.5% 23.2% 20.0% 13.9% |12.0% 4.8% 18.2% 21.0% |
|TERMINAL (d) | 7/20 (35%) 5/30 (17%) 6/32 (19%) 3/17 (18%) |4/30 (13%) 1/32 (3%) 6/32 (19%) 3/25 (12%) |
|FIRST INCIDENCE | 593 593 645 607 |682 703 703 593 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.113N P=0.323N P=0.164N P=0.143N |P=0.029 * P=0.193N P=0.327 P=0.150 |
|POLY 3 | P=0.172N P=0.548N P=0.405N P=0.222N |P=0.054 P=0.212N P=0.307 P=0.203 |
|POLY 1.5 | P=0.147N P=0.575N P=0.449N P=0.183N |P=0.053 P=0.215N P=0.298 P=0.198 |
|POLY 6 | P=0.160N P=0.495N P=0.339N P=0.218N |P=0.053 P=0.206N P=0.315 P=0.205 |
|LOGISTIC REGRESSION| P=0.153N P=0.548N P=0.314N P=0.210N |P=0.047 * P=0.201N P=0.323 P=0.187 |
|COCH-ARM / FISHERS | P=0.050N P=0.598N P=0.500N P=0.074N |P=0.048 * P=0.218N P=0.277 P=0.183 |
|ORDER RESTRICTED | P=0.259N (e) (e) (e) |P=0.067 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 23
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/40.18 0/41.64 0/44.41 0/28.31 |0/41.61 2/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 0.0% 0.0% |0.0% 4.8% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/30 (0%) 0/32 (0%) 0/17 (0%) |0/30 (0%) 2/32 (6%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.311N P=0.419N P=0.406N P=0.532N |P=0.441N P=0.252 (e) (e) |
|POLY 3 | P=0.240N P=0.493N P=0.480N P=0.568N |P=0.402N P=0.239 (e) (e) |
|POLY 1.5 | P=0.260N P=0.497N P=0.489N P=0.554N |P=0.403N P=0.238 (e) (e) |
|POLY 6 | P=0.233N P=0.485N P=0.466N P=0.568N |P=0.402N P=0.242 (e) (e) |
|LOGISTIC REGRESSION| P=0.311N (e) (e) (e) |(e) P=0.252 (e) (e) |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.409N P=0.247 (e) (e) |
|ORDER RESTRICTED | P=0.193N (e) (e) (e) |P=0.252N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/40.18 0/41.64 0/44.41 0/28.31 |1/41.61 2/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 0.0% 0.0% |2.4% 4.8% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/30 (0%) 0/32 (0%) 0/17 (0%) |1/30 (3%) 2/32 (6%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.311N P=0.419N P=0.406N P=0.532N |P=0.212N P=0.523 P=0.487N P=0.536N |
|POLY 3 | P=0.240N P=0.493N P=0.480N P=0.568N |P=0.187N P=0.503 P=0.490N P=0.503N |
|POLY 1.5 | P=0.260N P=0.497N P=0.489N P=0.554N |P=0.187N P=0.501 P=0.493N P=0.501N |
|POLY 6 | P=0.233N P=0.485N P=0.466N P=0.568N |P=0.187N P=0.508 P=0.487N P=0.507N |
|LOGISTIC REGRESSION| P=0.311N (e) (e) (e) |P=0.212N P=0.523 (e) (e) |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.191N P=0.500 P=0.500N P=0.505N |
|ORDER RESTRICTED | P=0.193N (e) (e) (e) |P=0.171N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 24
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/40.18 0/41.64 1/44.41 0/28.31 |2/41.61 0/42.03 1/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 0.0% |4.8% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/30 (0%) 1/32 (3%) 0/17 (0%) |2/30 (7%) 0/32 (0%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.689 (e) P=0.594 (e) |P=0.212N P=0.224N P=0.477N P=0.279N |
|POLY 3 | P=0.496 (e) P=0.520 (e) |P=0.190N P=0.235N P=0.483N P=0.240N |
|POLY 1.5 | P=0.547 (e) P=0.511 (e) |P=0.189N P=0.236N P=0.488N P=0.238N |
|POLY 6 | P=0.481 (e) P=0.534 (e) |P=0.193N P=0.231N P=0.478N P=0.245N |
|LOGISTIC REGRESSION| (e) (e) P=0.594 (e) |P=0.212N (e) P=0.477N (e) |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.191N P=0.247N P=0.500N P=0.253N |
|ORDER RESTRICTED | P=0.415 (e) (e) (e) |P=0.076N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | |0/41.61 0/42.03 0/43.75 2/41.07 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 0.0% 4.9% |
|TERMINAL (d) | |0/30 (0%) 0/32 (0%) 0/32 (0%) 2/25 (8%) |
|FIRST INCIDENCE | |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.031 * (e) (e) P=0.198 |
|POLY 3 | |P=0.044 * (e) (e) P=0.234 |
|POLY 1.5 | |P=0.044 * (e) (e) P=0.236 |
|POLY 6 | |P=0.043 * (e) (e) P=0.228 |
|LOGISTIC REGRESSION| |(e) (e) (e) P=0.198 |
|COCH-ARM / FISHERS | |P=0.045 * (e) (e) P=0.242 |
|ORDER RESTRICTED | |P=0.028 * (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 25
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |10/50 (20%) 10/50 (20%) 10/50 (20%) 10/49 (20%) |
|POLY-3 RATE (b) | |10/43.56 10/42.41 10/44.90 10/42.91 |
|POLY-3 PERCENT (g) | |23.0% 23.6% 22.3% 23.3% |
|TERMINAL (d) | |6/30 (20%) 9/32 (28%) 6/32 (19%) 4/25 (16%) |
|FIRST INCIDENCE | |394 621 465 456 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.412 P=0.554N P=0.524N P=0.494 |
|POLY 3 | |P=0.545 P=0.574 P=0.570N P=0.586 |
|POLY 1.5 | |P=0.548 P=0.581 P=0.577N P=0.591 |
|POLY 6 | |P=0.530 P=0.573 P=0.566N P=0.571 |
|LOGISTIC REGRESSION| |P=0.535 P=0.596N P=0.594 P=0.571 |
|COCH-ARM / FISHERS | |P=0.526 P=0.598N P=0.598N P=0.579 |
|ORDER RESTRICTED | |P=0.723N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 22/50 (44%) 13/50 (26%) 6/50 (12%) |9/50 (18%) 9/50 (18%) 7/50 (14%) 15/49 (31%) |
|POLY-3 RATE (b) | 13/42.99 22/45.56 13/46.15 6/29.00 |9/42.76 9/42.48 7/44.82 15/43.32 |
|POLY-3 PERCENT (g) | 30.2% 48.3% 28.2% 20.7% |21.1% 21.2% 15.6% 34.6% |
|TERMINAL (d) | 3/20 (15%) 12/30 (40%) 6/32 (19%) 3/17 (18%) |4/30 (13%) 7/32 (22%) 3/32 (9%) 8/25 (32%) |
|FIRST INCIDENCE | 522 522 556 606 |535 621 535 593 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.068N P=0.211 P=0.281N P=0.219N |P=0.042 * P=0.549N P=0.345N P=0.083 |
|POLY 3 | P=0.112N P=0.059 P=0.507N P=0.270N |P=0.075 P=0.598 P=0.352N P=0.119 |
|POLY 1.5 | P=0.077N P=0.051 P=0.546N P=0.203N |P=0.074 P=0.598 P=0.364N P=0.119 |
|POLY 6 | P=0.114N P=0.080 P=0.449N P=0.292N |P=0.073 P=0.602 P=0.343N P=0.115 |
|LOGISTIC REGRESSION| P=0.043N* P=0.046 * P=0.564 P=0.199N |P=0.071 P=0.595N P=0.378N P=0.114 |
|COCH-ARM / FISHERS | P=0.010N* P=0.046 * P=0.590N P=0.062N |P=0.068 P=0.602N P=0.393N P=0.109 |
|ORDER RESTRICTED | P=0.093N (e) (e) (e) |P=0.064 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 26
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/40.59 0/41.64 0/44.41 1/28.31 |0/41.61 0/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 4.9% 0.0% 0.0% 3.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/30 (0%) 0/32 (0%) 1/17 (6%) |0/30 (0%) 0/32 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 608 --- --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.522N P=0.198N P=0.173N P=0.576N |(e) (e) (e) (e) |
|POLY 3 | P=0.401N P=0.231N P=0.217N P=0.621N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.425N P=0.234N P=0.226N P=0.596N |(e) (e) (e) (e) |
|POLY 6 | P=0.389N P=0.224N P=0.204N P=0.625N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.531N P=0.239N P=0.250N P=0.615N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.461N P=0.247N P=0.247N P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.213N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/40.44 2/42.29 4/44.58 1/28.65 |0/41.61 0/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 2.5% 4.7% 9.0% 3.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/30 (0%) 2/32 (6%) 0/17 (0%) |0/30 (0%) 0/32 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 657 601 694 634 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.483 P=0.503 P=0.315 P=0.672 |(e) (e) (e) (e) |
|POLY 3 | P=0.358 P=0.516 P=0.209 P=0.678 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.404 P=0.507 P=0.195 P=0.696 |(e) (e) (e) (e) |
|POLY 6 | P=0.356 P=0.531 P=0.232 P=0.679 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.502 P=0.492 P=0.221 P=0.729 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.596 P=0.500 P=0.181 P=0.753N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.365 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 27
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/40.44 2/42.29 4/44.58 1/28.65 |0/41.61 0/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 2.5% 4.7% 9.0% 3.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/30 (0%) 2/32 (6%) 0/17 (0%) |0/30 (0%) 0/32 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 657 601 694 634 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.483 P=0.503 P=0.315 P=0.672 |(e) (e) (e) (e) |
|POLY 3 | P=0.358 P=0.516 P=0.209 P=0.678 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.404 P=0.507 P=0.195 P=0.696 |(e) (e) (e) (e) |
|POLY 6 | P=0.356 P=0.531 P=0.232 P=0.679 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.502 P=0.492 P=0.221 P=0.729 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.596 P=0.500 P=0.181 P=0.753N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.365 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/40.18 0/41.64 0/44.41 2/28.51 |0/41.61 0/42.03 0/43.75 0/41.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/30 (0%) 0/32 (0%) 1/17 (6%) |0/30 (0%) 0/32 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- --- 676 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.020 * (e) (e) P=0.180 |(e) (e) (e) (e) |
|POLY 3 | P=0.038 * (e) (e) P=0.170 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.038 * (e) (e) P=0.182 |(e) (e) (e) (e) |
|POLY 6 | P=0.039 * (e) (e) P=0.171 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.022 * (e) (e) P=0.165 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 28
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 48/50 (96%) 50/50 (100%) 32/50 (64%) |44/50 (88%) 41/50 (82%) 41/50 (82%) 39/49 (80%) |
|POLY-3 RATE (b) | 47/48.36 48/48.71 50/50.00 32/33.39 |44/46.95 41/46.52 41/47.91 39/46.61 |
|POLY-3 PERCENT (g) | 97.2% 98.6% 100.0% 95.8% |93.7% 88.1% 85.6% 83.7% |
|TERMINAL (d) | 20/20 (100%) 30/30 (100%) 32/32 (100%) 17/17 (100%)|29/30 (97%) 28/32 (88%) 28/32 (88%) 21/25 (84%) |
|FIRST INCIDENCE | 522 444 444 290 |394 522 465 456 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.240N P=0.077N P=0.032N* P=0.277N |P=0.449 P=0.237N P=0.200N P=0.547 |
|POLY 3 | P=0.602N P=0.637 P=0.321 P=0.677N |P=0.084N P=0.267N P=0.148N P=0.092N |
|POLY 1.5 | P=0.021N* P=0.552 P=0.191 P=0.059N |P=0.096N P=0.284N P=0.179N P=0.109N |
|POLY 6 | P=0.464 P=0.881 P=0.758 P=0.934 |P=0.094N P=0.222N P=0.130N P=0.091N |
|LOGISTIC REGRESSION| P=0.364 P=0.477 P=0.160 P=0.570 |P=0.107N P=0.267N P=0.159N P=0.122N |
|COCH-ARM / FISHERS | P<0.001N** P=0.500 P=0.121 P<0.001N** |P=0.190N P=0.288N P=0.288N P=0.194N |
|ORDER RESTRICTED | P=0.125N (e) (e) (e) |P=0.087N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 31/50 (62%) 27/50 (54%) 15/50 (30%) |22/50 (44%) 14/50 (28%) 16/50 (32%) 23/49 (47%) |
|POLY-3 RATE (b) | 34/47.18 31/48.18 27/47.46 15/30.62 |22/45.65 14/43.24 16/45.88 23/45.42 |
|POLY-3 PERCENT (g) | 72.1% 64.3% 56.9% 49.0% |48.2% 32.4% 34.9% 50.6% |
|TERMINAL (d) | 12/20 (60%) 14/30 (47%) 15/32 (47%) 9/17 (53%) |9/30 (30%) 9/32 (28%) 9/32 (28%) 9/25 (36%) |
|FIRST INCIDENCE | 463 485 556 319 |394 513 465 456 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.015N* P=0.117N P=0.010N* P=0.030N* |P=0.178 P=0.079N P=0.135N P=0.357 |
|POLY 3 | P=0.020N* P=0.274N P=0.086N P=0.032N* |P=0.297 P=0.093N P=0.137N P=0.491 |
|POLY 1.5 | P=0.006N** P=0.306N P=0.097N P=0.008N** |P=0.290 P=0.083N P=0.136N P=0.493 |
|POLY 6 | P=0.033N* P=0.223N P=0.071N P=0.060N |P=0.292 P=0.108N P=0.148N P=0.471 |
|LOGISTIC REGRESSION| P<0.001N** P=0.364N P=0.120N P=0.008N** |P=0.261 P=0.071N P=0.153N P=0.459 |
|COCH-ARM / FISHERS | P<0.001N** P=0.338N P=0.109N P<0.001N** |P=0.256 P=0.072N P=0.151N P=0.463 |
|ORDER RESTRICTED | P=0.038N* (e) (e) (e) |P=0.181 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/03/05 EXPERIMENT: 93020 TEST: 07 Page 29
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 50/50 (100%) 33/50 (66%) |48/50 (96%) 45/50 (90%) 44/50 (88%) 45/49 (92%) |
|POLY-3 RATE (b) | 50/50.00 50/50.00 50/50.00 33/34.31 |48/48.16 45/47.24 44/48.97 45/47.75 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 96.2% |99.7% 95.3% 89.9% 94.2% |
|TERMINAL (d) | 20/20 (100%) 30/30 (100%) 32/32 (100%) 17/17 (100%)|30/30 (100%) 30/32 (94%) 28/32 (88%) 23/25 (92%) |
|FIRST INCIDENCE | 463 444 444 290 |394 513 465 456 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.170N (e) (e) P=0.226N |P=0.304 P=0.237N P=0.162N P=0.397 |
|POLY 3 | P<0.001N** (e) (e) P=0.131N |P=0.151N P=0.217N P=0.035N* P=0.143N |
|POLY 1.5 | P<0.001N** (e) (e) P<0.001N** |P=0.165N P=0.195N P=0.044N* P=0.158N |
|POLY 6 | P=0.737N (e) (e) P=1.000N |P=0.177N P=0.231N P=0.036N* P=0.175N |
|LOGISTIC REGRESSION| P=0.093N (e) (e) P=0.364N |P=0.165N P=0.165N P=0.052N P=0.134N |
|COCH-ARM / FISHERS | P<0.001N** (e) (e) P<0.001N** |P=0.337N P=0.218N P=0.134N P=0.329N |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P=0.054N (e) (e) (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).