TDMS Study 93020-08 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst DIISOPROPYLCARBODIIMIDE DATE: 07/19/04
EXPERIMENT: 93020 TEST: 08 TIME: 09:14:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-05451 ROUTE: SKIN APPLICATION NTP C#: 93020D
PATHOLOGIST: FARNELL, DANIEL CAS: 693-13-0
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1 MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst DIISOPROPYLCARBODIIMIDE DATE: 07/19/04
EXPERIMENT: 93020 TEST: 08 TIME: 09:14:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05451 ROUTE: SKIN APPLICATION NTP C#: 93020D
PATHOLOGIST: FARNELL, DANIEL CAS: 693-13-0
Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Bone Marrow
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pancreas
Pituitary Gland
Prostate
Spleen
Testes
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst DIISOPROPYLCARBODIIMIDE DATE: 07/19/04
EXPERIMENT: 93020 TEST: 08 TIME: 09:14:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05451 ROUTE: SKIN APPLICATION NTP C#: 93020D
PATHOLOGIST: FARNELL, DANIEL CAS: 693-13-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF DIISOPROPYLCARBODIIMIDE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Liver Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Harderian Gland Adenoma
Carcinoma or Adenoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Carcinoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Uterus Leiomyosarcoma
Polyp Stromal
Sarcoma Stromal or Polyp Stromal
All Organs Hemangiosarcoma
Hemangiosarcoma or Hemangioma
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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) | 5/50 (10%) 3/50 (6%) 6/50 (12%) 5/49 (10%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/47.01 3/46.01 6/44.90 5/43.04 |0/42.68 0/43.63 0/43.22 1/45.13 |
|POLY-3 PERCENT (g) | 10.6% 6.5% 13.4% 11.6% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 4/39 (10%) 3/40 (8%) 5/38 (13%) 4/36 (11%) |0/33 (0%) 0/33 (0%) 0/38 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 682 729 (T) 713 642 |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.388 P=0.347N P=0.479 P=0.576 |P=0.225 (e) (e) P=0.538 |
|POLY 3 | P=0.391 P=0.368N P=0.468 P=0.574 |P=0.206 (e) (e) P=0.511 |
|POLY 1.5 | P=0.399 P=0.368N P=0.470 P=0.580 |P=0.203 (e) (e) P=0.508 |
|POLY 6 | P=0.386 P=0.368N P=0.466 P=0.569 |P=0.210 (e) (e) P=0.515 |
|LOGISTIC REGRESSION| P=0.383 P=0.364N P=0.468 P=0.575 |(e) (e) (e) P=0.538 |
|COCH-ARM / FISHERS | P=0.437 P=0.357N P=0.500 P=0.617 |P=0.199 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.435 (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 |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/46.28 0/46.01 1/44.84 2/43.80 |1/42.52 0/43.63 0/44.22 0/44.17 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 4.6% |2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 1/38 (3%) 1/36 (3%) |0/33 (0%) 0/33 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 642 |683 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.063 (e) P=0.495 P=0.226 |P=0.295N P=0.500N P=0.485N P=0.485N |
|POLY 3 | P=0.064 (e) P=0.494 P=0.225 |P=0.309N P=0.495N P=0.492N P=0.492N |
|POLY 1.5 | P=0.065 (e) P=0.495 P=0.228 |P=0.309N P=0.494N P=0.494N P=0.494N |
|POLY 6 | P=0.063 (e) P=0.493 P=0.222 |P=0.307N P=0.499N P=0.490N P=0.490N |
|LOGISTIC REGRESSION| P=0.068 (e) P=0.495 P=0.243 |P=0.305N P=0.496N P=0.496N P=0.500N |
|COCH-ARM / FISHERS | P=0.071 (e) P=0.505 P=0.253 |P=0.305N P=0.495N P=0.495N P=0.500N |
|ORDER RESTRICTED | P=0.067 (e) (e) (e) |P=0.113N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 9/50 (18%) 10/50 (20%) 8/50 (16%) |9/50 (18%) 5/50 (10%) 5/50 (10%) 3/50 (6%) |
|POLY-3 RATE (b) | 9/46.92 9/46.27 10/45.36 8/44.20 |9/43.07 5/43.63 5/44.22 3/46.01 |
|POLY-3 PERCENT (g) | 19.2% 19.5% 22.1% 18.1% |20.9% 11.5% 11.3% 6.5% |
|TERMINAL (d) | 8/39 (21%) 8/40 (20%) 8/38 (21%) 7/36 (19%) |8/33 (24%) 5/33 (15%) 5/39 (13%) 1/40 (3%) |
|FIRST INCIDENCE | 706 660 625 474 |619 729 (T) 729 (T) 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.540N P=0.583N P=0.473 P=0.571N |P=0.026N* P=0.188N P=0.117N P=0.037N* |
|POLY 3 | P=0.511N P=0.590 P=0.467 P=0.554N |P=0.042N* P=0.183N P=0.176N P=0.045N* |
|POLY 1.5 | P=0.502N P=0.587 P=0.465 P=0.546N |P=0.046N* P=0.183N P=0.185N P=0.050N |
|POLY 6 | P=0.522N P=0.596 P=0.473 P=0.563N |P=0.036N* P=0.192N P=0.168N P=0.040N* |
|LOGISTIC REGRESSION| P=0.518N P=0.591 P=0.458 P=0.557N |P=0.044N* P=0.192N P=0.159N P=0.056N |
|COCH-ARM / FISHERS | P=0.450N P=0.602N P=0.500 P=0.500N |P=0.054N P=0.194N P=0.194N P=0.061N |
|ORDER RESTRICTED | P=0.622N (e) (e) (e) |P=0.026N* (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 |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 4/50 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.84 1/46.01 0/44.84 3/43.48 |1/43.11 0/43.63 4/44.63 1/45.13 |
|POLY-3 PERCENT (g) | 4.3% 2.2% 0.0% 6.9% |2.3% 0.0% 9.0% 2.2% |
|TERMINAL (d) | 1/39 (3%) 1/40 (3%) 0/38 (0%) 3/36 (8%) |0/33 (0%) 0/33 (0%) 3/39 (8%) 1/40 (3%) |
|FIRST INCIDENCE | 725 729 (T) --- 729 (T) |603 --- 614 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.304 P=0.494N P=0.248N P=0.461 |P=0.501 P=0.500N P=0.216 P=0.737N |
|POLY 3 | P=0.322 P=0.506N P=0.247N P=0.466 |P=0.470 P=0.498N P=0.189 P=0.750N |
|POLY 1.5 | P=0.325 P=0.507N P=0.247N P=0.472 |P=0.461 P=0.497N P=0.184 P=0.753N |
|POLY 6 | P=0.319 P=0.505N P=0.247N P=0.460 |P=0.483 P=0.502N P=0.195 P=0.748N |
|LOGISTIC REGRESSION| P=0.298 P=0.504N P=0.248N P=0.451 |P=0.448 P=0.509N P=0.180 P=0.758 |
|COCH-ARM / FISHERS | P=0.337 P=0.500N P=0.247N P=0.500 |P=0.444 P=0.500N P=0.181 P=0.753N |
|ORDER RESTRICTED | P=0.164 (e) (e) (e) |P=0.194 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 10/50 (20%) 10/50 (20%) 11/50 (22%) |10/50 (20%) 5/50 (10%) 8/50 (16%) 4/50 (8%) |
|POLY-3 RATE (b) | 10/46.94 10/46.27 10/45.36 11/44.20 |10/43.50 5/43.63 8/44.63 4/46.01 |
|POLY-3 PERCENT (g) | 21.3% 21.6% 22.1% 24.9% |23.0% 11.5% 17.9% 8.7% |
|TERMINAL (d) | 8/39 (21%) 9/40 (23%) 8/38 (21%) 10/36 (28%) |8/33 (24%) 5/33 (15%) 7/39 (18%) 2/40 (5%) |
|FIRST INCIDENCE | 706 660 625 474 |603 729 (T) 614 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347 P=0.578N P=0.568 P=0.419 |P=0.050N P=0.129N P=0.279N P=0.045N* |
|POLY 3 | P=0.378 P=0.585 P=0.566 P=0.438 |P=0.076N P=0.125N P=0.373N P=0.056N |
|POLY 1.5 | P=0.387 P=0.582 P=0.563 P=0.447 |P=0.084N P=0.123N P=0.386N P=0.061N |
|POLY 6 | P=0.366 P=0.591 P=0.572 P=0.427 |P=0.065N P=0.136N P=0.361N P=0.051N |
|LOGISTIC REGRESSION| P=0.364 P=0.587 P=0.557 P=0.426 |P=0.084N P=0.122N P=0.371N P=0.069N |
|COCH-ARM / FISHERS | P=0.441 P=0.598N P=0.598N P=0.500 |P=0.098N P=0.131N P=0.398N P=0.074N |
|ORDER RESTRICTED | P=0.536 (e) (e) (e) |P=0.040N* (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 |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.83 0/46.01 3/45.12 1/43.48 |0/42.68 0/43.63 1/44.22 1/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.7% 2.3% |0.0% 0.0% 2.3% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 2/38 (5%) 1/36 (3%) |0/33 (0%) 0/33 (0%) 1/39 (3%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- 653 729 (T) |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.226 (e) P=0.119 P=0.484 |P=0.274 (e) P=0.533 P=0.538 |
|POLY 3 | P=0.215 (e) P=0.112 P=0.485 |P=0.250 (e) P=0.507 P=0.511 |
|POLY 1.5 | P=0.221 (e) P=0.112 P=0.488 |P=0.246 (e) P=0.503 P=0.508 |
|POLY 6 | P=0.208 (e) P=0.113 P=0.483 |P=0.258 (e) P=0.511 P=0.515 |
|LOGISTIC REGRESSION| P=0.234 (e) P=0.116 P=0.484 |(e) (e) P=0.533 P=0.538 |
|COCH-ARM / FISHERS | P=0.247 (e) P=0.121 P=0.500 |P=0.236 (e) P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.108 (e) (e) (e) |P=0.258 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 4/50 (8%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.83 1/46.45 4/45.12 1/43.48 |1/42.68 1/43.63 1/44.22 1/45.13 |
|POLY-3 PERCENT (g) | 2.1% 2.2% 8.9% 2.3% |2.3% 2.3% 2.3% 2.2% |
|TERMINAL (d) | 1/39 (3%) 0/40 (0%) 3/38 (8%) 1/36 (3%) |1/33 (3%) 1/33 (3%) 1/39 (3%) 1/40 (3%) |
|FIRST INCIDENCE | 729 (T) 603 653 729 (T) |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491 P=0.755N P=0.174 P=0.744 |P=0.570N P=0.762 P=0.724N P=0.718N |
|POLY 3 | P=0.478 P=0.759 P=0.168 P=0.744 |P=0.621N P=0.756N P=0.753N P=0.748N |
|POLY 1.5 | P=0.488 P=0.757 P=0.168 P=0.747 |P=0.625N P=0.756N P=0.757N P=0.752N |
|POLY 6 | P=0.467 P=0.760N P=0.169 P=0.741 |P=0.614N P=0.759N P=0.749N P=0.744N |
|LOGISTIC REGRESSION| P=0.516 P=0.747N P=0.168 P=0.744 |P=0.570N P=0.762 P=0.724N P=0.718N |
|COCH-ARM / FISHERS | P=0.526 P=0.753N P=0.181 P=0.753N |P=0.634 P=0.753N P=0.753N P=0.753N |
|ORDER RESTRICTED | P=0.307 (e) (e) (e) |P=0.730N (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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 0/49 (0%) 1/50 (2%) |0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.28 1/46.01 0/44.29 1/43.48 |0/42.68 2/43.17 0/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 2.2% 2.2% 0.0% 2.3% |0.0% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 1/39 (3%) 1/40 (3%) 0/38 (0%) 1/36 (3%) |0/33 (0%) 1/33 (3%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |--- 625 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.640N P=0.756N P=0.505N P=0.744 |P=0.382N P=0.242 (e) (e) |
|POLY 3 | P=0.619N P=0.759 P=0.509N P=0.747 |P=0.388N P=0.240 (e) (e) |
|POLY 1.5 | P=0.618N P=0.760 P=0.508N P=0.750 |P=0.392N P=0.238 (e) (e) |
|POLY 6 | P=0.620N P=0.759 P=0.509N P=0.742 |P=0.384N P=0.238 (e) (e) |
|LOGISTIC REGRESSION| P=0.640N P=0.756N (e) P=0.744 |P=0.405N P=0.233 (e) (e) |
|COCH-ARM / FISHERS | P=0.612N P=0.747N P=0.500N P=0.747N |P=0.404N P=0.242 (e) (e) |
|ORDER RESTRICTED | P=0.554N (e) (e) (e) |P=0.239N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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) | 1/49 (2%) 1/50 (2%) 1/49 (2%) 1/50 (2%) |0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.28 1/46.01 1/44.66 1/43.48 |0/42.68 2/43.17 0/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 2.2% 2.2% 2.2% 2.3% |0.0% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 1/39 (3%) 1/40 (3%) 0/38 (0%) 1/36 (3%) |0/33 (0%) 1/33 (3%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 625 729 (T) |--- 625 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.610 P=0.756N P=0.755 P=0.744 |P=0.382N P=0.242 (e) (e) |
|POLY 3 | P=0.609 P=0.759 P=0.753 P=0.747 |P=0.388N P=0.240 (e) (e) |
|POLY 1.5 | P=0.614 P=0.760 P=0.752 P=0.750 |P=0.392N P=0.238 (e) (e) |
|POLY 6 | P=0.602 P=0.759 P=0.754 P=0.742 |P=0.384N P=0.238 (e) (e) |
|LOGISTIC REGRESSION| P=0.629 P=0.756N P=0.755N P=0.744 |P=0.405N P=0.233 (e) (e) |
|COCH-ARM / FISHERS | P=0.630N P=0.747N P=0.753N P=0.747N |P=0.404N P=0.242 (e) (e) |
|ORDER RESTRICTED | P=0.728 (e) (e) (e) |P=0.239N (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 |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/49 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.83 2/46.01 1/44.84 1/42.92 |1/42.68 1/43.76 0/44.22 1/45.13 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 2.2% 2.3% |2.3% 2.3% 0.0% 2.2% |
|TERMINAL (d) | 0/39 (0%) 2/40 (5%) 1/38 (3%) 0/36 (0%) |1/33 (3%) 0/33 (0%) 0/39 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 674 |729 (T) 695 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.472 P=0.244 P=0.495 P=0.481 |P=0.568N P=0.754 P=0.467N P=0.718N |
|POLY 3 | P=0.463 P=0.233 P=0.491 P=0.483 |P=0.610N P=0.755N P=0.493N P=0.748N |
|POLY 1.5 | P=0.467 P=0.233 P=0.492 P=0.484 |P=0.613N P=0.756N P=0.497N P=0.752N |
|POLY 6 | P=0.460 P=0.234 P=0.491 P=0.481 |P=0.607N P=0.758N P=0.489N P=0.744N |
|LOGISTIC REGRESSION| P=0.474 P=0.244 P=0.495 P=0.507 |P=0.597N P=0.760N (e) P=0.718N |
|COCH-ARM / FISHERS | P=0.494 P=0.247 P=0.500 P=0.495 |P=0.616N P=0.753N P=0.500N P=0.753N |
|ORDER RESTRICTED | P=0.271 (e) (e) (e) |P=0.520N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 22/50 (44%) 19/50 (38%) 19/49 (39%) |21/50 (42%) 27/50 (54%) 21/50 (42%) 18/50 (36%) |
|POLY-3 RATE (b) | 18/46.83 22/46.67 19/45.74 19/43.91 |21/43.39 27/44.95 21/44.66 18/45.56 |
|POLY-3 PERCENT (g) | 38.4% 47.1% 41.5% 43.3% |48.4% 60.1% 47.0% 39.5% |
|TERMINAL (d) | 18/39 (46%) 20/40 (50%) 16/38 (42%) 17/36 (47%) |19/33 (58%) 22/33 (67%) 20/39 (51%) 16/40 (40%) |
|FIRST INCIDENCE | 729 (T) 603 493 498 |603 579 603 619 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.400 P=0.295 P=0.457 P=0.373 |P=0.025N* P=0.146 P=0.311N P=0.122N |
|POLY 3 | P=0.442 P=0.260 P=0.463 P=0.399 |P=0.100N P=0.181 P=0.534N P=0.262N |
|POLY 1.5 | P=0.446 P=0.251 P=0.454 P=0.401 |P=0.118N P=0.179 P=0.560N P=0.285N |
|POLY 6 | P=0.441 P=0.275 P=0.477 P=0.402 |P=0.081N P=0.169 P=0.510N P=0.239N |
|LOGISTIC REGRESSION| P=0.401 P=0.246 P=0.432 P=0.354 |P=0.078N P=0.151 P=0.487N P=0.230N |
|COCH-ARM / FISHERS | P=0.524 P=0.270 P=0.500 P=0.469 |P=0.161N P=0.158 P=0.580N P=0.341N |
|ORDER RESTRICTED | P=0.467 (e) (e) (e) |P=0.117N (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 Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 15/50 (30%) 11/50 (22%) 11/49 (22%) |10/50 (20%) 2/50 (4%) 8/50 (16%) 3/50 (6%) |
|POLY-3 RATE (b) | 20/49.51 15/48.49 11/46.88 11/44.48 |10/43.35 2/43.63 8/45.04 3/45.17 |
|POLY-3 PERCENT (g) | 40.4% 30.9% 23.5% 24.7% |23.1% 4.6% 17.8% 6.6% |
|TERMINAL (d) | 12/39 (31%) 8/40 (20%) 4/38 (11%) 6/36 (17%) |6/33 (18%) 2/33 (6%) 7/39 (18%) 2/40 (5%) |
|FIRST INCIDENCE | 515 435 496 474 |619 729 (T) 417 718 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.079N P=0.226N P=0.080N P=0.099N |P=0.044N* P=0.019N* P=0.286N P=0.021N* |
|POLY 3 | P=0.057N P=0.222N P=0.058N P=0.081N |P=0.067N P=0.012N* P=0.362N P=0.028N* |
|POLY 1.5 | P=0.051N P=0.223N P=0.056N P=0.072N |P=0.072N P=0.012N* P=0.377N P=0.030N* |
|POLY 6 | P=0.064N P=0.220N P=0.058N P=0.091N |P=0.060N P=0.014N* P=0.351N P=0.026N* |
|LOGISTIC REGRESSION| P=0.027N* P=0.165N P=0.031N* P=0.038N* |P=0.071N P=0.014N* P=0.382N P=0.028N* |
|COCH-ARM / FISHERS | P=0.034N* P=0.201N P=0.041N* P=0.047N* |P=0.083N P=0.014N* P=0.398N P=0.036N* |
|ORDER RESTRICTED | P=0.063N (e) (e) (e) |P=0.012N* (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 16/50 (32%) 11/50 (22%) 11/49 (22%) |10/50 (20%) 2/50 (4%) 8/50 (16%) 3/50 (6%) |
|POLY-3 RATE (b) | 20/49.51 16/48.49 11/46.88 11/44.48 |10/43.35 2/43.63 8/45.04 3/45.17 |
|POLY-3 PERCENT (g) | 40.4% 33.0% 23.5% 24.7% |23.1% 4.6% 17.8% 6.6% |
|TERMINAL (d) | 12/39 (31%) 9/40 (23%) 4/38 (11%) 6/36 (17%) |6/33 (18%) 2/33 (6%) 7/39 (18%) 2/40 (5%) |
|FIRST INCIDENCE | 515 435 496 474 |619 729 (T) 417 718 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.071N P=0.285N P=0.080N P=0.099N |P=0.044N* P=0.019N* P=0.286N P=0.021N* |
|POLY 3 | P=0.050N P=0.292N P=0.058N P=0.081N |P=0.067N P=0.012N* P=0.362N P=0.028N* |
|POLY 1.5 | P=0.044N* P=0.292N P=0.056N P=0.072N |P=0.072N P=0.012N* P=0.377N P=0.030N* |
|POLY 6 | P=0.056N P=0.289N P=0.058N P=0.091N |P=0.060N P=0.014N* P=0.351N P=0.026N* |
|LOGISTIC REGRESSION| P=0.023N* P=0.226N P=0.031N* P=0.038N* |P=0.071N P=0.014N* P=0.382N P=0.028N* |
|COCH-ARM / FISHERS | P=0.029N* P=0.266N P=0.041N* P=0.047N* |P=0.083N P=0.014N* P=0.398N P=0.036N* |
|ORDER RESTRICTED | P=0.064N (e) (e) (e) |P=0.012N* (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 Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 35/50 (70%) 33/50 (66%) 29/50 (58%) 29/49 (59%) |29/50 (58%) 29/50 (58%) 26/50 (52%) 20/50 (40%) |
|POLY-3 RATE (b) | 35/49.51 33/48.92 29/47.63 29/45.68 |29/44.06 29/44.95 26/45.47 20/45.56 |
|POLY-3 PERCENT (g) | 70.7% 67.5% 60.9% 63.5% |65.8% 64.5% 57.2% 43.9% |
|TERMINAL (d) | 27/39 (69%) 25/40 (63%) 20/38 (53%) 22/36 (61%) |23/33 (70%) 24/33 (73%) 24/39 (62%) 18/40 (45%) |
|FIRST INCIDENCE | 515 435 493 474 |603 579 417 619 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.308N P=0.395N P=0.253N P=0.340N |P<0.001N** P=0.575 P=0.109N P=0.008N** |
|POLY 3 | P=0.236N P=0.449N P=0.210N P=0.297N |P=0.011N* P=0.538N P=0.262N P=0.026N* |
|POLY 1.5 | P=0.219N P=0.459N P=0.213N P=0.280N |P=0.015N* P=0.537N P=0.295N P=0.032N* |
|POLY 6 | P=0.259N P=0.428N P=0.202N P=0.319N |P=0.008N** P=0.579N P=0.244N P=0.023N* |
|LOGISTIC REGRESSION| P=0.175N P=0.415N P=0.172N P=0.228N |P=0.008N** P=0.554N P=0.262N P=0.020N* |
|COCH-ARM / FISHERS | P=0.135N P=0.415N P=0.149N P=0.180N |P=0.028N* P=0.580N P=0.344N P=0.055N |
|ORDER RESTRICTED | P=0.303N (e) (e) (e) |P=0.020N* (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 35/50 (70%) 33/50 (66%) 29/50 (58%) 29/49 (59%) |29/50 (58%) 29/50 (58%) 26/50 (52%) 20/50 (40%) |
|POLY-3 RATE (b) | 35/49.51 33/48.92 29/47.63 29/45.68 |29/44.06 29/44.95 26/45.47 20/45.56 |
|POLY-3 PERCENT (g) | 70.7% 67.5% 60.9% 63.5% |65.8% 64.5% 57.2% 43.9% |
|TERMINAL (d) | 27/39 (69%) 25/40 (63%) 20/38 (53%) 22/36 (61%) |23/33 (70%) 24/33 (73%) 24/39 (62%) 18/40 (45%) |
|FIRST INCIDENCE | 515 435 493 474 |603 579 417 619 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.308N P=0.395N P=0.253N P=0.340N |P<0.001N** P=0.575 P=0.109N P=0.008N** |
|POLY 3 | P=0.236N P=0.449N P=0.210N P=0.297N |P=0.011N* P=0.538N P=0.262N P=0.026N* |
|POLY 1.5 | P=0.219N P=0.459N P=0.213N P=0.280N |P=0.015N* P=0.537N P=0.295N P=0.032N* |
|POLY 6 | P=0.259N P=0.428N P=0.202N P=0.319N |P=0.008N** P=0.579N P=0.244N P=0.023N* |
|LOGISTIC REGRESSION| P=0.175N P=0.415N P=0.172N P=0.228N |P=0.008N** P=0.554N P=0.262N P=0.020N* |
|COCH-ARM / FISHERS | P=0.135N P=0.415N P=0.149N P=0.180N |P=0.028N* P=0.580N P=0.344N P=0.055N |
|ORDER RESTRICTED | P=0.303N (e) (e) (e) |P=0.020N* (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 |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 6/50 (12%) 7/50 (14%) 8/50 (16%) |4/50 (8%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 6/47.28 6/46.01 7/45.05 8/43.48 |4/43.24 2/43.91 3/44.22 1/45.13 |
|POLY-3 PERCENT (g) | 12.7% 13.0% 15.5% 18.4% |9.3% 4.6% 6.8% 2.2% |
|TERMINAL (d) | 5/39 (13%) 6/40 (15%) 5/38 (13%) 8/36 (22%) |2/33 (6%) 1/33 (3%) 3/39 (8%) 1/40 (3%) |
|FIRST INCIDENCE | 598 729 (T) 690 729 (T) |603 653 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.232 P=0.604N P=0.477 P=0.325 |P=0.121N P=0.347N P=0.432N P=0.144N |
|POLY 3 | P=0.242 P=0.601 P=0.463 P=0.323 |P=0.151N P=0.330N P=0.488N P=0.166N |
|POLY 1.5 | P=0.254 P=0.603 P=0.466 P=0.337 |P=0.155N P=0.329N P=0.494N P=0.169N |
|POLY 6 | P=0.229 P=0.600 P=0.461 P=0.309 |P=0.145N P=0.337N P=0.482N P=0.162N |
|LOGISTIC REGRESSION| P=0.235 P=0.609 P=0.470 P=0.323 |P=0.151N P=0.332N P=0.487N P=0.171N |
|COCH-ARM / FISHERS | P=0.300 P=0.620N P=0.500 P=0.387 |P=0.162N P=0.339N P=0.500N P=0.181N |
|ORDER RESTRICTED | P=0.356 (e) (e) (e) |P=0.117N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 4/50 (8%) 2/50 (4%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 2/46.83 3/46.01 4/44.84 2/43.71 |0/42.68 2/43.91 2/44.81 5/45.13 |
|POLY-3 PERCENT (g) | 4.3% 6.5% 8.9% 4.6% |0.0% 4.6% 4.5% 11.1% |
|TERMINAL (d) | 2/39 (5%) 3/40 (8%) 4/38 (11%) 1/36 (3%) |0/33 (0%) 1/33 (3%) 0/39 (0%) 5/40 (13%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 667 |--- 653 603 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.558 P=0.512 P=0.324 P=0.663 |P=0.028 * P=0.240 P=0.248 P=0.052 |
|POLY 3 | P=0.559 P=0.492 P=0.317 P=0.669 |P=0.019 * P=0.243 P=0.248 P=0.035 * |
|POLY 1.5 | P=0.566 P=0.491 P=0.318 P=0.673 |P=0.018 * P=0.243 P=0.243 P=0.034 * |
|POLY 6 | P=0.552 P=0.493 P=0.317 P=0.666 |P=0.020 * P=0.241 P=0.255 P=0.037 * |
|LOGISTIC REGRESSION| P=0.558 P=0.512 P=0.324 P=0.672 |P=0.018 * P=0.240 P=0.237 P=0.052 |
|COCH-ARM / FISHERS | P=0.562N P=0.500 P=0.339 P=0.691N |P=0.016 * P=0.247 P=0.247 P=0.028 * |
|ORDER RESTRICTED | P=0.489 (e) (e) (e) |P=0.012 * (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 |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 9/50 (18%) 11/50 (22%) 10/50 (20%) |4/50 (8%) 4/50 (8%) 5/50 (10%) 6/50 (12%) |
|POLY-3 RATE (b) | 8/47.28 9/46.01 11/45.05 10/43.71 |4/43.24 4/44.19 5/44.81 6/45.13 |
|POLY-3 PERCENT (g) | 16.9% 19.6% 24.4% 22.9% |9.3% 9.1% 11.2% 13.3% |
|TERMINAL (d) | 7/39 (18%) 9/40 (23%) 9/38 (24%) 9/36 (25%) |2/33 (6%) 2/33 (6%) 3/39 (8%) 6/40 (15%) |
|FIRST INCIDENCE | 598 729 (T) 690 667 |603 653 603 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.249 P=0.522 P=0.283 P=0.326 |P=0.375 P=0.634 P=0.565 P=0.478 |
|POLY 3 | P=0.260 P=0.476 P=0.264 P=0.327 |P=0.294 P=0.632N P=0.522 P=0.396 |
|POLY 1.5 | P=0.275 P=0.478 P=0.268 P=0.341 |P=0.287 P=0.632N P=0.511 P=0.390 |
|POLY 6 | P=0.247 P=0.473 P=0.261 P=0.314 |P=0.303 P=0.639N P=0.534 P=0.403 |
|LOGISTIC REGRESSION| P=0.251 P=0.486 P=0.268 P=0.326 |P=0.289 P=0.639N P=0.506 P=0.404 |
|COCH-ARM / FISHERS | P=0.335 P=0.500 P=0.306 P=0.398 |P=0.270 P=0.643N P=0.500 P=0.370 |
|ORDER RESTRICTED | P=0.342 (e) (e) (e) |P=0.421 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.86 0/46.01 0/44.84 0/43.48 |1/42.80 0/43.63 2/44.51 0/45.13 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 0.0% |2.3% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 0/33 (0%) 1/39 (3%) 0/40 (0%) |
|FIRST INCIDENCE | 721 --- --- --- |698 --- 653 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.322N P=0.505N P=0.515N P=0.526N |P=0.427N P=0.511N P=0.531 P=0.474N |
|POLY 3 | P=0.299N P=0.504N P=0.509N P=0.515N |P=0.447N P=0.496N P=0.514 P=0.489N |
|POLY 1.5 | P=0.300N P=0.504N P=0.508N P=0.512N |P=0.452N P=0.496N P=0.507 P=0.493N |
|POLY 6 | P=0.298N P=0.503N P=0.509N P=0.518N |P=0.438N P=0.499N P=0.521 P=0.486N |
|LOGISTIC REGRESSION| P=0.315N P=0.503N P=0.509N P=0.517N |P=0.457N P=0.497N P=0.503 P=0.495N |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.461N P=0.500N P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.134N (e) (e) (e) |P=0.315N (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 |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |1/49 (2%) 2/50 (4%) 2/49 (4%) 2/49 (4%) |
|POLY-3 RATE (b) | |1/41.68 2/43.63 2/43.71 2/44.17 |
|POLY-3 PERCENT (g) | |2.4% 4.6% 4.6% 4.5% |
|TERMINAL (d) | |1/32 (3%) 2/33 (6%) 2/39 (5%) 2/40 (5%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.518 P=0.511 P=0.569 P=0.578 |
|POLY 3 | |P=0.448 P=0.516 P=0.517 P=0.520 |
|POLY 1.5 | |P=0.438 P=0.515 P=0.508 P=0.514 |
|POLY 6 | |P=0.460 P=0.512 P=0.526 P=0.528 |
|LOGISTIC REGRESSION| |P=0.518 P=0.511 P=0.569 P=0.578 |
|COCH-ARM / FISHERS | |P=0.420 P=0.508 P=0.500 P=0.500 |
|ORDER RESTRICTED | |P=0.486 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/47 (0%) 0/50 (0%) 0/49 (0%) |4/48 (8%) 12/50 (24%) 3/50 (6%) 10/46 (22%) |
|POLY-3 RATE (b) | 0/44.84 0/43.75 0/44.84 0/42.71 |4/41.44 12/44.68 3/44.22 10/42.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |9.7% 26.9% 6.8% 23.7% |
|TERMINAL (d) | 0/38 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |3/32 (9%) 9/33 (27%) 3/39 (8%) 10/38 (26%) |
|FIRST INCIDENCE | --- --- --- --- |521 540 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.313 P=0.036 * P=0.405N P=0.130 |
|POLY 3 | (e) (e) (e) (e) |P=0.187 P=0.035 * P=0.465N P=0.074 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.177 P=0.035 * P=0.472N P=0.070 |
|POLY 6 | (e) (e) (e) (e) |P=0.200 P=0.034 * P=0.458N P=0.080 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.199 P=0.037 * P=0.468N P=0.081 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.164 P=0.033 * P=0.477N P=0.062 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.061 (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) | 0/48 (0%) 0/47 (0%) 0/50 (0%) 0/49 (0%) |5/48 (10%) 12/50 (24%) 3/50 (6%) 10/46 (22%) |
|POLY-3 RATE (b) | 0/44.84 0/43.75 0/44.84 0/42.71 |5/41.56 12/44.68 3/44.22 10/42.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |12.0% 26.9% 6.8% 23.7% |
|TERMINAL (d) | 0/38 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |3/32 (9%) 9/33 (27%) 3/39 (8%) 10/38 (26%) |
|FIRST INCIDENCE | --- --- --- --- |521 540 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.408 P=0.068 P=0.273N P=0.217 |
|POLY 3 | (e) (e) (e) (e) |P=0.261 P=0.070 P=0.322N P=0.132 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.250 P=0.070 P=0.329N P=0.125 |
|POLY 6 | (e) (e) (e) (e) |P=0.275 P=0.066 P=0.317N P=0.140 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.276 P=0.070 P=0.324N P=0.140 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.233 P=0.065 P=0.335N P=0.112 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.120 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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) | 0/48 (0%) 0/47 (0%) 1/50 (2%) 0/49 (0%) |0/48 (0%) 2/50 (4%) 1/50 (2%) 1/46 (2%) |
|POLY-3 RATE (b) | 0/44.84 0/43.75 1/44.84 0/42.71 |0/40.81 2/43.63 1/44.22 1/42.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 0.0% |0.0% 4.6% 2.3% 2.4% |
|TERMINAL (d) | 0/38 (0%) 0/40 (0%) 1/38 (3%) 0/36 (0%) |0/32 (0%) 2/33 (6%) 1/39 (3%) 1/38 (3%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.687 (e) P=0.500 (e) |P=0.556 P=0.245 P=0.539 P=0.534 |
|POLY 3 | P=0.671 (e) P=0.500 (e) |P=0.518 P=0.252 P=0.516 P=0.506 |
|POLY 1.5 | P=0.676 (e) P=0.500 (e) |P=0.507 P=0.252 P=0.512 P=0.501 |
|POLY 6 | P=0.666 (e) P=0.500 (e) |P=0.532 P=0.249 P=0.520 P=0.512 |
|LOGISTIC REGRESSION| (e) (e) P=0.500 (e) |(e) P=0.245 P=0.539 P=0.534 |
|COCH-ARM / FISHERS | P=0.699 (e) P=0.510 (e) |P=0.484 P=0.258 P=0.510 P=0.489 |
|ORDER RESTRICTED | P=0.381 (e) (e) (e) |P=0.288 (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 Cell Adenoma or Basosquamous Tumor Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.83 0/46.01 0/44.84 0/43.48 |0/42.68 0/43.63 2/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 0/33 (0%) 2/39 (5%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.637 (e) P=0.276 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.622 (e) P=0.245 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.613 (e) P=0.241 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.634 (e) P=0.249 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.276 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.595 (e) P=0.247 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.254 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or |
| Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.83 0/46.01 0/44.84 0/43.48 |0/42.68 0/43.63 2/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 0/33 (0%) 2/39 (5%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.637 (e) P=0.276 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.622 (e) P=0.245 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.613 (e) P=0.241 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.634 (e) P=0.249 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.276 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.595 (e) P=0.247 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.254 (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 Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.83 0/46.01 0/44.84 0/43.48 |0/42.68 0/43.63 2/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 0/33 (0%) 2/39 (5%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.637 (e) P=0.276 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.622 (e) P=0.245 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.613 (e) P=0.241 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.634 (e) P=0.249 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.276 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.595 (e) P=0.247 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.254 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.83 0/46.01 0/44.84 0/43.48 |0/42.68 0/43.63 3/44.22 1/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 6.8% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 0/33 (0%) 3/39 (8%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.303 (e) P=0.152 P=0.538 |
|POLY 3 | (e) (e) (e) (e) |P=0.269 (e) P=0.125 P=0.511 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.261 (e) P=0.122 P=0.508 |
|POLY 6 | (e) (e) (e) (e) |P=0.281 (e) P=0.128 P=0.515 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.152 P=0.538 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.247 (e) P=0.121 P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.121 (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) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.83 1/46.24 0/44.84 0/43.48 |1/42.96 2/43.63 0/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 2.1% 2.2% 0.0% 0.0% |2.3% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 1/39 (3%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 2/33 (6%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 670 --- --- |653 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.252N P=0.760N P=0.505N P=0.516N |P=0.165N P=0.500 P=0.495N P=0.495N |
|POLY 3 | P=0.242N P=0.758 P=0.509N P=0.515N |P=0.181N P=0.505 P=0.494N P=0.490N |
|POLY 1.5 | P=0.241N P=0.757 P=0.508N P=0.512N |P=0.183N P=0.506 P=0.497N P=0.493N |
|POLY 6 | P=0.242N P=0.759 P=0.509N P=0.517N |P=0.180N P=0.499 P=0.491N P=0.487N |
|LOGISTIC REGRESSION| P=0.238N P=0.762N (e) (e) |P=0.182N P=0.506 P=0.501N P=0.508N |
|COCH-ARM / FISHERS | P=0.236N P=0.753N P=0.500N P=0.500N |P=0.188N P=0.500 P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.264N (e) (e) (e) |P=0.161N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.83 0/46.01 0/44.84 0/43.48 |2/43.11 1/43.63 0/44.22 1/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.6% 2.3% 0.0% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |1/33 (3%) 1/33 (3%) 0/39 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- |603 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.322N P=0.500N P=0.221N P=0.453N |
|POLY 3 | (e) (e) (e) (e) |P=0.363N P=0.496N P=0.231N P=0.484N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.365N P=0.495N P=0.235N P=0.489N |
|POLY 6 | (e) (e) (e) (e) |P=0.359N P=0.503N P=0.228N P=0.480N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.360N P=0.497N P=0.238N P=0.498N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.366N P=0.500N P=0.247N P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.211N (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 |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.83 0/46.01 0/44.84 1/43.48 |2/43.04 1/43.91 0/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.3% |4.7% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 1/36 (3%) |0/33 (0%) 0/33 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |681 653 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.187 (e) (e) P=0.484 |P=0.096N P=0.503N P=0.226N P=0.226N |
|POLY 3 | P=0.190 (e) (e) P=0.485 |P=0.099N P=0.493N P=0.231N P=0.227N |
|POLY 1.5 | P=0.192 (e) (e) P=0.488 |P=0.100N P=0.493N P=0.234N P=0.230N |
|POLY 6 | P=0.188 (e) (e) P=0.483 |P=0.098N P=0.498N P=0.228N P=0.224N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.484 |P=0.101N P=0.502N P=0.237N P=0.237N |
|COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.500 |P=0.101N P=0.500N P=0.247N P=0.247N |
|ORDER RESTRICTED | P=0.108 (e) (e) (e) |P=0.067N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 16
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 2/47 (4%) |1/49 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.28 0/46.01 1/44.84 2/41.10 |1/42.14 1/43.04 0/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 4.9% |2.4% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 1/38 (3%) 1/35 (3%) |0/33 (0%) 0/33 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 642 |683 695 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.061 (e) P=0.495 P=0.223 |P=0.221N P=0.754 P=0.485N P=0.485N |
|POLY 3 | P=0.057 (e) P=0.494 P=0.211 |P=0.230N P=0.756N P=0.490N P=0.486N |
|POLY 1.5 | P=0.058 (e) P=0.495 P=0.214 |P=0.231N P=0.756N P=0.493N P=0.489N |
|POLY 6 | P=0.056 (e) P=0.493 P=0.209 |P=0.229N P=0.759N P=0.488N P=0.484N |
|LOGISTIC REGRESSION| P=0.061 (e) P=0.495 P=0.228 |P=0.230N P=0.761N P=0.495N P=0.496N |
|COCH-ARM / FISHERS | P=0.064 (e) P=0.505 P=0.237 |P=0.232N P=0.753N P=0.495N P=0.495N |
|ORDER RESTRICTED | P=0.059 (e) (e) (e) |P=0.238N (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 |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/46.94 1/46.01 1/44.84 2/43.48 |1/42.68 1/44.02 2/44.22 2/45.13 |
|POLY-3 PERCENT (g) | 2.1% 2.2% 2.2% 4.6% |2.3% 2.3% 4.5% 4.4% |
|TERMINAL (d) | 0/39 (0%) 1/40 (3%) 1/38 (3%) 2/36 (6%) |1/33 (3%) 0/33 (0%) 2/39 (5%) 2/40 (5%) |
|FIRST INCIDENCE | 702 729 (T) 729 (T) 729 (T) |729 (T) 617 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.320 P=0.758 P=0.749 P=0.467 |P=0.403 P=0.755N P=0.558 P=0.567 |
|POLY 3 | P=0.328 P=0.756 P=0.750 P=0.473 |P=0.358 P=0.754N P=0.512 P=0.519 |
|POLY 1.5 | P=0.332 P=0.756 P=0.751 P=0.478 |P=0.351 P=0.755N P=0.506 P=0.513 |
|POLY 6 | P=0.322 P=0.756 P=0.750 P=0.468 |P=0.368 P=0.756N P=0.519 P=0.526 |
|LOGISTIC REGRESSION| P=0.320 P=0.759 P=0.754 P=0.471 |P=0.354 P=0.762 P=0.558 P=0.567 |
|COCH-ARM / FISHERS | P=0.351 P=0.753N P=0.753N P=0.500 |P=0.337 P=0.753N P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.380 (e) (e) (e) |P=0.457 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 17
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/46.94 1/46.01 1/44.84 1/43.48 |1/42.68 1/44.02 1/44.22 2/45.13 |
|POLY-3 PERCENT (g) | 2.1% 2.2% 2.2% 2.3% |2.3% 2.3% 2.3% 4.4% |
|TERMINAL (d) | 0/39 (0%) 1/40 (3%) 1/38 (3%) 1/36 (3%) |1/33 (3%) 0/33 (0%) 1/39 (3%) 2/40 (5%) |
|FIRST INCIDENCE | 702 729 (T) 729 (T) 729 (T) |729 (T) 617 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.606 P=0.758 P=0.749 P=0.738 |P=0.409 P=0.755N P=0.724N P=0.567 |
|POLY 3 | P=0.606 P=0.756 P=0.750 P=0.743 |P=0.368 P=0.754N P=0.753N P=0.519 |
|POLY 1.5 | P=0.612 P=0.756 P=0.751 P=0.747 |P=0.362 P=0.755N P=0.757N P=0.513 |
|POLY 6 | P=0.601 P=0.756 P=0.750 P=0.740 |P=0.376 P=0.756N P=0.749N P=0.526 |
|LOGISTIC REGRESSION| P=0.609 P=0.759 P=0.754 P=0.747 |P=0.363 P=0.762 P=0.724N P=0.567 |
|COCH-ARM / FISHERS | P=0.634 P=0.753N P=0.753N P=0.753N |P=0.351 P=0.753N P=0.753N P=0.500 |
|ORDER RESTRICTED | P=0.723 (e) (e) (e) |P=0.435 (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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/46.28 1/46.01 0/44.84 1/43.55 |3/42.68 0/43.63 0/44.22 2/45.13 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 2.3% |7.0% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 0/39 (0%) 1/40 (3%) 0/38 (0%) 0/36 (0%) |3/33 (9%) 0/33 (0%) 0/39 (0%) 2/40 (5%) |
|FIRST INCIDENCE | --- 729 (T) --- 712 |729 (T) --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.385 P=0.505 (e) P=0.480 |P=0.458N P=0.120N P=0.093N P=0.412N |
|POLY 3 | P=0.386 P=0.499 (e) P=0.488 |P=0.532N P=0.114N P=0.112N P=0.475N |
|POLY 1.5 | P=0.391 P=0.499 (e) P=0.491 |P=0.533N P=0.115N P=0.116N P=0.483N |
|POLY 6 | P=0.382 P=0.498 (e) P=0.485 |P=0.526N P=0.116N P=0.109N P=0.466N |
|LOGISTIC REGRESSION| P=0.389 P=0.505 (e) P=0.491 |P=0.458N (e) (e) P=0.412N |
|COCH-ARM / FISHERS | P=0.408 P=0.505 (e) P=0.505 |P=0.531N P=0.121N P=0.121N P=0.500N |
|ORDER RESTRICTED | P=0.240 (e) (e) (e) |P=0.089N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 18
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| Leiomyosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | |0/42.68 0/43.63 0/44.22 2/45.13 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 0.0% 4.4% |
|TERMINAL (d) | |0/33 (0%) 0/33 (0%) 0/39 (0%) 2/40 (5%) |
|FIRST INCIDENCE | |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.060 (e) (e) P=0.282 |
|POLY 3 | |P=0.047 * (e) (e) P=0.250 |
|POLY 1.5 | |P=0.047 * (e) (e) P=0.246 |
|POLY 6 | |P=0.049 * (e) (e) P=0.254 |
|LOGISTIC REGRESSION| |(e) (e) (e) P=0.282 |
|COCH-ARM / FISHERS | |P=0.046 * (e) (e) P=0.247 |
|ORDER RESTRICTED | |P=0.034 * (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 |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |4/50 (8%) 2/50 (4%) 5/50 (10%) 0/50 (0%) |
|POLY-3 RATE (b) | |4/42.96 2/43.63 5/44.66 0/45.13 |
|POLY-3 PERCENT (g) | |9.3% 4.6% 11.2% 0.0% |
|TERMINAL (d) | |3/33 (9%) 2/33 (6%) 4/39 (10%) 0/40 (0%) |
|FIRST INCIDENCE | |654 729 (T) 603 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.063N P=0.341N P=0.582 P=0.047N* |
|POLY 3 | |P=0.081N P=0.330N P=0.524 P=0.054N |
|POLY 1.5 | |P=0.086N P=0.329N P=0.512 P=0.056N |
|POLY 6 | |P=0.076N P=0.338N P=0.537 P=0.052N |
|LOGISTIC REGRESSION| |P=0.085N P=0.332N P=0.515 P=0.056N |
|COCH-ARM / FISHERS | |P=0.095N P=0.339N P=0.500 P=0.059N |
|ORDER RESTRICTED | |P=0.049N* (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 19
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |4/50 (8%) 2/50 (4%) 5/50 (10%) 0/50 (0%) |
|POLY-3 RATE (b) | |4/42.96 2/43.63 5/44.66 0/45.13 |
|POLY-3 PERCENT (g) | |9.3% 4.6% 11.2% 0.0% |
|TERMINAL (d) | |3/33 (9%) 2/33 (6%) 4/39 (10%) 0/40 (0%) |
|FIRST INCIDENCE | |654 729 (T) 603 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.063N P=0.341N P=0.582 P=0.047N* |
|POLY 3 | |P=0.081N P=0.330N P=0.524 P=0.054N |
|POLY 1.5 | |P=0.086N P=0.329N P=0.512 P=0.056N |
|POLY 6 | |P=0.076N P=0.338N P=0.537 P=0.052N |
|LOGISTIC REGRESSION| |P=0.085N P=0.332N P=0.515 P=0.056N |
|COCH-ARM / FISHERS | |P=0.095N P=0.339N P=0.500 P=0.059N |
|ORDER RESTRICTED | |P=0.049N* (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 |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.83 0/46.01 1/44.84 0/43.48 |2/43.11 2/43.63 0/44.22 1/45.13 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 2.2% 0.0% |4.6% 4.6% 0.0% 2.2% |
|TERMINAL (d) | 1/39 (3%) 0/40 (0%) 1/38 (3%) 0/36 (0%) |1/33 (3%) 2/33 (6%) 0/39 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |603 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.423N P=0.495N P=0.756 P=0.516N |P=0.249N P=0.694 P=0.221N P=0.453N |
|POLY 3 | P=0.415N P=0.504N P=0.751 P=0.515N |P=0.289N P=0.690N P=0.231N P=0.484N |
|POLY 1.5 | P=0.413N P=0.504N P=0.751 P=0.512N |P=0.292N P=0.688N P=0.235N P=0.489N |
|POLY 6 | P=0.418N P=0.503N P=0.751 P=0.517N |P=0.285N P=0.692 P=0.228N P=0.480N |
|LOGISTIC REGRESSION| P=0.423N (e) P=0.756 (e) |P=0.286N P=0.690N P=0.238N P=0.498N |
|COCH-ARM / FISHERS | P=0.405N P=0.500N P=0.753N P=0.500N |P=0.296N P=0.691N P=0.247N P=0.500N |
|ORDER RESTRICTED | P=0.266N (e) (e) (e) |P=0.254N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 20
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 4/50 (8%) 3/50 (6%) |4/50 (8%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.83 2/46.01 4/44.84 3/44.01 |4/43.04 2/44.04 0/44.22 1/45.13 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 8.9% 6.8% |9.3% 4.5% 0.0% 2.2% |
|TERMINAL (d) | 0/39 (0%) 2/40 (5%) 4/38 (11%) 1/36 (3%) |2/33 (6%) 0/33 (0%) 0/39 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 642 |681 653 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.094 P=0.244 P=0.060 P=0.111 |P=0.071N P=0.347N P=0.052N P=0.144N |
|POLY 3 | P=0.094 P=0.233 P=0.055 P=0.108 |P=0.082N P=0.326N P=0.057N P=0.164N |
|POLY 1.5 | P=0.096 P=0.233 P=0.055 P=0.109 |P=0.084N P=0.327N P=0.059N P=0.168N |
|POLY 6 | P=0.092 P=0.234 P=0.055 P=0.107 |P=0.080N P=0.332N P=0.055N P=0.161N |
|LOGISTIC REGRESSION| P=0.098 P=0.244 P=0.060 P=0.121 |P=0.082N P=0.331N P=0.060N P=0.164N |
|COCH-ARM / FISHERS | P=0.113 P=0.247 P=0.059 P=0.121 |P=0.086N P=0.339N P=0.059N P=0.181N |
|ORDER RESTRICTED | P=0.061 (e) (e) (e) |P=0.033N* (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 |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 5/50 (10%) 3/50 (6%) |6/50 (12%) 4/50 (8%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/46.83 2/46.01 5/44.84 3/44.01 |6/43.48 4/44.04 0/44.22 2/45.13 |
|POLY-3 PERCENT (g) | 2.1% 4.4% 11.2% 6.8% |13.8% 9.1% 0.0% 4.4% |
|TERMINAL (d) | 1/39 (3%) 2/40 (5%) 5/38 (13%) 1/36 (3%) |3/33 (9%) 2/33 (6%) 0/39 (0%) 2/40 (5%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 642 |603 653 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.183 P=0.509 P=0.097 P=0.282 |P=0.038N* P=0.379N P=0.014N* P=0.100N |
|POLY 3 | P=0.185 P=0.494 P=0.092 P=0.283 |P=0.049N* P=0.361N P=0.014N* P=0.121N |
|POLY 1.5 | P=0.189 P=0.493 P=0.092 P=0.286 |P=0.050N P=0.359N P=0.015N* P=0.124N |
|POLY 6 | P=0.182 P=0.495 P=0.091 P=0.282 |P=0.047N* P=0.372N P=0.014N* P=0.118N |
|LOGISTIC REGRESSION| P=0.189 P=0.509 P=0.097 P=0.300 |P=0.050N P=0.360N P=0.017N* P=0.124N |
|COCH-ARM / FISHERS | P=0.216 P=0.500 P=0.102 P=0.309 |P=0.054N P=0.370N P=0.013N* P=0.134N |
|ORDER RESTRICTED | P=0.131 (e) (e) (e) |P=0.019N* (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 21
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/46.92 0/46.01 0/44.84 0/43.48 |3/43.38 1/43.91 2/45.26 2/45.95 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 0.0% |6.9% 2.3% 4.4% 4.4% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |2/33 (6%) 0/33 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 706 --- --- --- |488 653 560 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.318N P=0.505N P=0.510N P=0.520N |P=0.469N P=0.304N P=0.462N P=0.456N |
|POLY 3 | P=0.299N P=0.504N P=0.509N P=0.515N |P=0.481N P=0.301N P=0.481N P=0.474N |
|POLY 1.5 | P=0.300N P=0.504N P=0.509N P=0.512N |P=0.489N P=0.300N P=0.491N P=0.483N |
|POLY 6 | P=0.297N P=0.504N P=0.510N P=0.518N |P=0.468N P=0.305N P=0.469N P=0.462N |
|LOGISTIC REGRESSION| P=0.310N P=0.501N P=0.504N P=0.509N |P=0.524N P=0.312N P=0.500N P=0.530N |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.500N P=0.309N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.135N (e) (e) (e) |P=0.370N (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 Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |10/50 (20%) 9/50 (18%) 7/50 (14%) 7/50 (14%) |
|POLY-3 RATE (b) | 2/47.05 2/46.01 2/44.84 3/43.48 |10/44.78 9/45.50 7/44.39 7/45.17 |
|POLY-3 PERCENT (g) | 4.3% 4.4% 4.5% 6.9% |22.3% 19.8% 15.8% 15.5% |
|TERMINAL (d) | 1/39 (3%) 2/40 (5%) 2/38 (5%) 3/36 (8%) |6/33 (18%) 4/33 (12%) 6/39 (15%) 6/40 (15%) |
|FIRST INCIDENCE | 672 729 (T) 729 (T) 729 (T) |365 568 687 718 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.345 P=0.690N P=0.680 P=0.460 |P=0.141N P=0.494N P=0.213N P=0.195N |
|POLY 3 | P=0.353 P=0.686 P=0.676 P=0.464 |P=0.226N P=0.485N P=0.302N P=0.289N |
|POLY 1.5 | P=0.360 P=0.686 P=0.678 P=0.471 |P=0.227N P=0.487N P=0.305N P=0.290N |
|POLY 6 | P=0.345 P=0.686 P=0.675 P=0.456 |P=0.223N P=0.487N P=0.298N P=0.286N |
|LOGISTIC REGRESSION| P=0.346 P=0.690 P=0.682 P=0.465 |P=0.223N P=0.512N P=0.295N P=0.294N |
|COCH-ARM / FISHERS | P=0.387 P=0.691N P=0.691N P=0.500 |P=0.229N P=0.500N P=0.298N P=0.298N |
|ORDER RESTRICTED | P=0.447 (e) (e) (e) |P=0.320N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 22
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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) | 29/50 (58%) 31/50 (62%) 33/50 (66%) 31/50 (62%) |35/50 (70%) 38/50 (76%) 28/50 (56%) 31/50 (62%) |
|POLY-3 RATE (b) | 29/47.66 31/46.93 33/46.17 31/45.79 |35/44.73 38/46.31 28/45.66 31/46.05 |
|POLY-3 PERCENT (g) | 60.9% 66.1% 71.5% 67.7% |78.3% 82.1% 61.3% 67.3% |
|TERMINAL (d) | 25/39 (64%) 28/40 (70%) 28/38 (74%) 26/36 (72%) |29/33 (88%) 30/33 (91%) 26/39 (67%) 28/40 (70%) |
|FIRST INCIDENCE | 598 603 493 474 |521 540 67 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.183 P=0.470 P=0.221 P=0.247 |P=0.004N** P=0.334 P=0.010N* P=0.030N* |
|POLY 3 | P=0.269 P=0.376 P=0.188 P=0.315 |P=0.057N P=0.419 P=0.055N P=0.166N |
|POLY 1.5 | P=0.276 P=0.373 P=0.189 P=0.320 |P=0.069N P=0.399 P=0.066N P=0.187N |
|POLY 6 | P=0.254 P=0.384 P=0.187 P=0.304 |P=0.046N* P=0.399 P=0.051N P=0.151N |
|LOGISTIC REGRESSION| P=0.213 P=0.377 P=0.175 P=0.268 |P=0.052N P=0.410 P=0.073N P=0.128N |
|COCH-ARM / FISHERS | P=0.384 P=0.419 P=0.268 P=0.419 |P=0.113N P=0.326 P=0.107N P=0.263N |
|ORDER RESTRICTED | P=0.288 (e) (e) (e) |P=0.055N (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) | 27/50 (54%) 21/50 (42%) 22/50 (44%) 24/50 (48%) |26/50 (52%) 20/50 (40%) 26/50 (52%) 18/50 (36%) |
|POLY-3 RATE (b) | 27/50.00 21/48.49 22/47.25 24/48.00 |26/47.16 20/47.34 26/47.50 18/46.79 |
|POLY-3 PERCENT (g) | 54.0% 43.3% 46.6% 50.0% |55.1% 42.3% 54.7% 38.5% |
|TERMINAL (d) | 16/39 (41%) 14/40 (35%) 14/38 (37%) 12/36 (33%) |13/33 (39%) 10/33 (30%) 18/39 (46%) 13/40 (33%) |
|FIRST INCIDENCE | 515 435 496 474 |365 555 417 551 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491 P=0.195N P=0.305N P=0.511N |P=0.053N P=0.206N P=0.372N P=0.043N* |
|POLY 3 | P=0.473N P=0.196N P=0.299N P=0.424N |P=0.116N P=0.146N P=0.566N P=0.077N |
|POLY 1.5 | P=0.474N P=0.189N P=0.288N P=0.423N |P=0.112N P=0.145N P=0.581 P=0.074N |
|POLY 6 | P=0.470N P=0.204N P=0.309N P=0.424N |P=0.120N P=0.156N P=0.555N P=0.083N |
|LOGISTIC REGRESSION| P=0.391N P=0.137N P=0.206N P=0.292N |P=0.112N P=0.161N P=0.575N P=0.076N |
|COCH-ARM / FISHERS | P=0.405N P=0.158N P=0.212N P=0.345N |P=0.115N P=0.158N P=0.579N P=0.079N |
|ORDER RESTRICTED | P=0.368N (e) (e) (e) |P=0.078N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 23
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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) | 42/50 (84%) 42/50 (84%) 42/50 (84%) 41/50 (82%) |47/50 (94%) 43/50 (86%) 41/50 (82%) 41/50 (82%) |
|POLY-3 RATE (b) | 42/50.00 42/48.92 42/48.00 41/48.00 |47/48.07 43/48.20 41/48.50 41/47.28 |
|POLY-3 PERCENT (g) | 84.0% 85.9% 87.5% 85.4% |97.8% 89.2% 84.5% 86.7% |
|TERMINAL (d) | 31/39 (80%) 34/40 (85%) 32/38 (84%) 29/36 (81%) |32/33 (97%) 30/33 (91%) 32/39 (82%) 35/40 (88%) |
|FIRST INCIDENCE | 515 435 493 474 |365 540 67 551 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.326 P=0.524N P=0.476 P=0.403 |P=0.007N** P=0.289N P=0.026N* P=0.009N** |
|POLY 3 | P=0.478 P=0.510 P=0.419 P=0.534 |P=0.058N P=0.088N P=0.023N* P=0.041N* |
|POLY 1.5 | P=0.480 P=0.515 P=0.423 P=0.536 |P=0.049N* P=0.089N P=0.025N* P=0.033N* |
|POLY 6 | P=0.481 P=0.503 P=0.419 P=0.534 |P=0.072N P=0.109N P=0.025N* P=0.061N |
|LOGISTIC REGRESSION| P=0.507 P=0.576 P=0.489 P=0.594 |P=0.034N* P=0.076N P=0.053N P=0.014N* |
|COCH-ARM / FISHERS | P=0.436N P=0.607N P=0.607N P=0.500N |P=0.065N P=0.159N P=0.061N P=0.061N |
|ORDER RESTRICTED | P=0.572 (e) (e) (e) |P=0.030N* (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).