TDMS Study 56111-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRANS-CINNAMALDEHYDE DATE: 12/10/02
EXPERIMENT: 56111 TEST: 03 TIME: 10:51:06
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: 56111B
PATHOLOGIST: TOFT, JOHN CAS: 14371-10-9
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
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Prostate
Salivary Glands
Testes
Thymus
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRANS-CINNAMALDEHYDE DATE: 12/10/02
EXPERIMENT: 56111 TEST: 03 TIME: 10:51:06
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: 56111B
PATHOLOGIST: TOFT, JOHN CAS: 14371-10-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TRANS-CINNAMALDEHYDE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland Carcinoma or Adenoma
Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthom
a, Trichoepitheliom
Fibrosarcoma
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Islets, Pancreatic Carcinoma
===============================================================
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 4/50 (8%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/44.44 4/45.17 4/40.08 0/47.85 |0/45.04 2/44.73 0/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 11.3% 8.9% 10.0% 0.0% |0.0% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 5/29 (17%) 4/36 (11%) 2/27 (7%) 0/41 (0%) |0/34 (0%) 2/33 (6%) 0/35 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 731 (T) 731 (T) 676 --- |--- 735 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.015N* P=0.364N P=0.566N P=0.012N* |P=0.408N P=0.232 (e) (e) |
|POLY 3 | P=0.022N* P=0.490N P=0.565N P=0.025N* |P=0.411N P=0.236 (e) (e) |
|POLY 1.5 | P=0.025N* P=0.500N P=0.546N P=0.027N* |P=0.409N P=0.236 (e) (e) |
|POLY 6 | P=0.019N* P=0.473N P=0.584N P=0.021N* |P=0.413N P=0.234 (e) (e) |
|LOGISTIC REGRESSION| P=0.022N* P=0.364N P=0.610N (e) |(e) P=0.232 (e) (e) |
|COCH-ARM / FISHERS | P=0.029N* P=0.500N P=0.500N P=0.028N* |P=0.405N P=0.247 (e) (e) |
|ORDER RESTRICTED | P=0.022N* (e) (e) (e) |P=0.250N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 4/50 (8%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/44.44 4/45.17 4/40.08 0/47.85 |1/45.04 2/44.73 1/43.67 0/44.16 |
|POLY-3 PERCENT (g) | 11.3% 8.9% 10.0% 0.0% |2.2% 4.5% 2.3% 0.0% |
|TERMINAL (d) | 5/29 (17%) 4/36 (11%) 2/27 (7%) 0/41 (0%) |1/34 (3%) 2/33 (6%) 0/35 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 731 (T) 731 (T) 676 --- |735 (T) 735 (T) 498 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.015N* P=0.364N P=0.566N P=0.012N* |P=0.251N P=0.490 P=0.757 P=0.506N |
|POLY 3 | P=0.022N* P=0.490N P=0.565N P=0.025N* |P=0.254N P=0.498 P=0.754 P=0.504N |
|POLY 1.5 | P=0.025N* P=0.500N P=0.546N P=0.027N* |P=0.252N P=0.498 P=0.754 P=0.502N |
|POLY 6 | P=0.019N* P=0.473N P=0.584N P=0.021N* |P=0.255N P=0.495 P=0.756 P=0.506N |
|LOGISTIC REGRESSION| P=0.022N* P=0.364N P=0.610N (e) |P=0.245N P=0.490 P=0.751N (e) |
|COCH-ARM / FISHERS | P=0.029N* P=0.500N P=0.500N P=0.028N* |P=0.248N P=0.500 P=0.747 P=0.500N |
|ORDER RESTRICTED | P=0.022N* (e) (e) (e) |P=0.228N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 2/50 (4%) 0/50 (0%) |4/49 (8%) 4/50 (8%) 1/49 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/44.58 1/44.33 2/39.95 0/47.85 |4/44.09 4/44.88 1/42.98 2/44.16 |
|POLY-3 PERCENT (g) | 4.5% 2.3% 5.0% 0.0% |9.1% 8.9% 2.3% 4.5% |
|TERMINAL (d) | 1/29 (3%) 1/36 (3%) 1/27 (4%) 0/41 (0%) |3/33 (9%) 3/33 (9%) 1/35 (3%) 2/33 (6%) |
|FIRST INCIDENCE | 696 731 (T) 655 --- |723 697 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.164N P=0.450N P=0.630 P=0.187N |P=0.185N P=0.636 P=0.167N P=0.340N |
|POLY 3 | P=0.184N P=0.502N P=0.654 P=0.222N |P=0.188N P=0.634N P=0.186N P=0.336N |
|POLY 1.5 | P=0.190N P=0.507N P=0.666 P=0.229N |P=0.186N P=0.634N P=0.185N P=0.333N |
|POLY 6 | P=0.176N P=0.493N P=0.640 P=0.212N |P=0.189N P=0.636N P=0.185N P=0.339N |
|LOGISTIC REGRESSION| P=0.191N P=0.490N P=0.657 P=0.224N |P=0.185N P=0.645N P=0.170N P=0.334N |
|COCH-ARM / FISHERS | P=0.199N P=0.508N P=0.691N P=0.247N |P=0.182N P=0.631N P=0.181N P=0.329N |
|ORDER RESTRICTED | P=0.144N (e) (e) (e) |P=0.215N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/49 (4%) 3/50 (6%) 1/50 (2%) |3/49 (6%) 1/50 (2%) 2/49 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/44.44 2/45.38 3/40.55 1/47.85 |3/44.55 1/44.88 2/42.98 2/44.56 |
|POLY-3 PERCENT (g) | 6.8% 4.4% 7.4% 2.1% |6.7% 2.2% 4.7% 4.5% |
|TERMINAL (d) | 3/29 (10%) 0/36 (0%) 1/27 (4%) 1/41 (2%) |1/33 (3%) 0/33 (0%) 2/35 (6%) 0/33 (0%) |
|FIRST INCIDENCE | 731 (T) 404 577 731 (T) |597 697 735 (T) 634 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.210N P=0.439N P=0.619 P=0.191N |P=0.505N P=0.314N P=0.490N P=0.511N |
|POLY 3 | P=0.241N P=0.490N P=0.620 P=0.279N |P=0.500N P=0.302N P=0.516N P=0.500N |
|POLY 1.5 | P=0.250N P=0.502N P=0.631 P=0.291N |P=0.498N P=0.301N P=0.511N P=0.497N |
|POLY 6 | P=0.228N P=0.473N P=0.608 P=0.263N |P=0.501N P=0.306N P=0.518N P=0.503N |
|LOGISTIC REGRESSION| P=0.273N P=0.474N P=0.647 P=0.191N |P=0.495N P=0.296N P=0.505N P=0.486N |
|COCH-ARM / FISHERS | P=0.261N P=0.510N P=0.661N P=0.309N |P=0.494N P=0.301N P=0.500N P=0.490N |
|ORDER RESTRICTED | P=0.239N (e) (e) (e) |P=0.398N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/49 (6%) 5/50 (10%) 1/50 (2%) |7/49 (14%) 5/50 (10%) 3/49 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 5/44.58 3/45.38 5/40.83 1/47.85 |7/44.60 5/45.03 3/42.98 4/44.56 |
|POLY-3 PERCENT (g) | 11.2% 6.6% 12.3% 2.1% |15.7% 11.1% 7.0% 9.0% |
|TERMINAL (d) | 4/29 (14%) 1/36 (3%) 2/27 (7%) 1/41 (2%) |4/33 (12%) 3/33 (9%) 3/35 (9%) 2/33 (6%) |
|FIRST INCIDENCE | 696 404 577 731 (T) |597 697 735 (T) 634 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.078N P=0.287N P=0.550 P=0.048N* |P=0.202N P=0.392N P=0.150N P=0.276N |
|POLY 3 | P=0.093N P=0.346N P=0.575 P=0.086N |P=0.198N P=0.372N P=0.172N P=0.261N |
|POLY 1.5 | P=0.100N P=0.359N P=0.589 P=0.093N |P=0.195N P=0.370N P=0.168N P=0.257N |
|POLY 6 | P=0.084N P=0.327N P=0.560 P=0.077N |P=0.199N P=0.377N P=0.173N P=0.265N |
|LOGISTIC REGRESSION| P=0.114N P=0.354N P=0.589 P=0.066N |P=0.197N P=0.368N P=0.166N P=0.255N |
|COCH-ARM / FISHERS | P=0.110N P=0.369N P=0.630N P=0.102N |P=0.190N P=0.365N P=0.159N P=0.251N |
|ORDER RESTRICTED | P=0.072N (e) (e) (e) |P=0.186N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/44.44 0/45.17 1/39.85 0/47.85 |0/45.04 1/44.73 0/42.98 2/44.31 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 2.5% 0.0% |0.0% 2.2% 0.0% 4.5% |
|TERMINAL (d) | 1/29 (3%) 0/36 (0%) 0/27 (0%) 0/41 (0%) |0/34 (0%) 1/33 (3%) 0/35 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 731 (T) --- 682 --- |--- 735 (T) --- 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.370N P=0.457N P=0.723 P=0.431N |P=0.138 P=0.494 (e) P=0.236 |
|POLY 3 | P=0.397N P=0.497N P=0.736 P=0.485N |P=0.137 P=0.499 (e) P=0.233 |
|POLY 1.5 | P=0.400N P=0.500N P=0.744 P=0.492N |P=0.138 P=0.499 (e) P=0.235 |
|POLY 6 | P=0.393N P=0.491N P=0.728 P=0.476N |P=0.136 P=0.497 (e) P=0.232 |
|LOGISTIC REGRESSION| P=0.399N (e) P=0.736 (e) |P=0.136 P=0.494 (e) P=0.234 |
|COCH-ARM / FISHERS | P=0.405N P=0.500N P=0.753N P=0.500N |P=0.140 P=0.500 (e) P=0.247 |
|ORDER RESTRICTED | P=0.237N (e) (e) (e) |P=0.073 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.44 0/45.17 0/39.67 1/47.85 |2/45.34 0/44.73 0/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.1% |4.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/36 (0%) 0/27 (0%) 1/41 (2%) |1/34 (3%) 0/33 (0%) 0/35 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- 731 (T) |652 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.239 (e) (e) P=0.569 |P=0.120N P=0.243N P=0.244N P=0.251N |
|POLY 3 | P=0.209 (e) (e) P=0.515 |P=0.114N P=0.240N P=0.249N P=0.243N |
|POLY 1.5 | P=0.205 (e) (e) P=0.508 |P=0.114N P=0.239N P=0.247N P=0.241N |
|POLY 6 | P=0.214 (e) (e) P=0.524 |P=0.112N P=0.243N P=0.250N P=0.246N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.569 |P=0.115N P=0.237N P=0.241N P=0.236N |
|COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.500 |P=0.116N P=0.247N P=0.253N P=0.247N |
|ORDER RESTRICTED | P=0.134 (e) (e) (e) |P=0.031N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/44.44 0/45.17 1/39.85 1/47.85 |2/45.34 1/44.73 0/42.98 2/44.31 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 2.5% 2.1% |4.4% 2.2% 0.0% 4.5% |
|TERMINAL (d) | 1/29 (3%) 0/36 (0%) 0/27 (0%) 1/41 (2%) |1/34 (3%) 1/33 (3%) 0/35 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 731 (T) --- 682 731 (T) |652 735 (T) --- 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.594 P=0.457N P=0.723 P=0.683N |P=0.582 P=0.507N P=0.244N P=0.681 |
|POLY 3 | P=0.561 P=0.497N P=0.736 P=0.744N |P=0.584 P=0.505N P=0.249N P=0.686 |
|POLY 1.5 | P=0.552 P=0.500N P=0.744 P=0.751N |P=0.586 P=0.503N P=0.247N P=0.689 |
|POLY 6 | P=0.571 P=0.491N P=0.728 P=0.733N |P=0.584 P=0.509N P=0.250N P=0.682 |
|LOGISTIC REGRESSION| P=0.557 (e) P=0.736 P=0.683N |P=0.586 P=0.501N P=0.241N P=0.693 |
|COCH-ARM / FISHERS | P=0.539 P=0.500N P=0.753N P=0.753N |P=0.590 P=0.500N P=0.253N P=0.691N |
|ORDER RESTRICTED | P=0.520 (e) (e) (e) |P=0.409 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 6/50 (12%) 1/50 (2%) |2/50 (4%) 2/50 (4%) 2/49 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/44.65 6/45.17 6/40.04 1/47.85 |2/45.04 2/44.73 2/42.98 2/44.31 |
|POLY-3 PERCENT (g) | 4.5% 13.3% 15.0% 2.1% |4.4% 4.5% 4.7% 4.5% |
|TERMINAL (d) | 1/29 (3%) 6/36 (17%) 5/27 (19%) 1/41 (2%) |2/34 (6%) 2/33 (6%) 2/35 (6%) 1/33 (3%) |
|FIRST INCIDENCE | 676 731 (T) 624 731 (T) |735 (T) 735 (T) 735 (T) 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.171N P=0.205 P=0.106 P=0.407N |P=0.591 P=0.685 P=0.685N P=0.686 |
|POLY 3 | P=0.229N P=0.136 P=0.099 P=0.476N |P=0.587 P=0.692 P=0.677 P=0.688 |
|POLY 1.5 | P=0.249N P=0.132 P=0.110 P=0.487N |P=0.590 P=0.692 P=0.679 P=0.690 |
|POLY 6 | P=0.202N P=0.143 P=0.089 P=0.461N |P=0.586 P=0.690 P=0.678 P=0.687 |
|LOGISTIC REGRESSION| P=0.231N P=0.157 P=0.091 P=0.487N |P=0.586 P=0.685 P=0.685N P=0.685 |
|COCH-ARM / FISHERS | P=0.277N P=0.134 P=0.134 P=0.500N |P=0.595 P=0.691N P=0.684 P=0.691N |
|ORDER RESTRICTED | P=0.092N (e) (e) (e) |P=0.734 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.44 0/45.17 2/39.67 1/47.85 |1/45.04 0/44.73 0/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 5.0% 2.1% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/36 (0%) 2/27 (7%) 1/41 (2%) |1/34 (3%) 0/33 (0%) 0/35 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- 731 (T) 731 (T) |735 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.315 (e) P=0.222 P=0.569 |P=0.307N P=0.506N P=0.494N P=0.506N |
|POLY 3 | P=0.276 (e) P=0.213 P=0.515 |P=0.306N P=0.501N P=0.509N P=0.504N |
|POLY 1.5 | P=0.264 (e) P=0.220 P=0.508 |P=0.306N P=0.501N P=0.508N P=0.502N |
|POLY 6 | P=0.293 (e) P=0.204 P=0.524 |P=0.304N P=0.503N P=0.509N P=0.506N |
|LOGISTIC REGRESSION| (e) (e) P=0.222 P=0.569 |P=0.307N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.246 (e) P=0.247 P=0.500 |P=0.306N P=0.500N P=0.505N P=0.500N |
|ORDER RESTRICTED | P=0.149 (e) (e) (e) |P=0.124N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 8/50 (16%) 2/50 (4%) |3/50 (6%) 2/50 (4%) 2/49 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/44.65 6/45.17 8/40.04 2/47.85 |3/45.04 2/44.73 2/42.98 2/44.31 |
|POLY-3 PERCENT (g) | 4.5% 13.3% 20.0% 4.2% |6.7% 4.5% 4.7% 4.5% |
|TERMINAL (d) | 1/29 (3%) 6/36 (17%) 7/27 (26%) 2/41 (5%) |3/34 (9%) 2/33 (6%) 2/35 (6%) 1/33 (3%) |
|FIRST INCIDENCE | 676 731 (T) 624 731 (T) |735 (T) 735 (T) 735 (T) 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.304N P=0.205 P=0.034 * P=0.586N |P=0.438N P=0.514N P=0.487N P=0.511N |
|POLY 3 | P=0.402N P=0.136 P=0.028 * P=0.669N |P=0.440N P=0.503N P=0.521N P=0.507N |
|POLY 1.5 | P=0.430N P=0.132 P=0.033 * P=0.680N |P=0.437N P=0.502N P=0.518N P=0.505N |
|POLY 6 | P=0.363N P=0.143 P=0.024 * P=0.652N |P=0.440N P=0.506N P=0.520N P=0.510N |
|LOGISTIC REGRESSION| P=0.389N P=0.157 P=0.025 * P=0.669N |P=0.442N P=0.514N P=0.487N P=0.514N |
|COCH-ARM / FISHERS | P=0.467N P=0.134 P=0.046 * P=0.691N |P=0.433N P=0.500N P=0.510N P=0.500N |
|ORDER RESTRICTED | P=0.139N (e) (e) (e) |P=0.507N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 3/49 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.44 0/45.17 0/39.67 0/47.85 |1/45.04 0/44.73 3/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 0.0% 7.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/36 (0%) 0/27 (0%) 0/41 (0%) |1/34 (3%) 0/33 (0%) 3/35 (9%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |735 (T) --- 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.505N P=0.506N P=0.315 P=0.506N |
|POLY 3 | (e) (e) (e) (e) |P=0.508N P=0.501N P=0.288 P=0.504N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.505N P=0.501N P=0.291 P=0.502N |
|POLY 6 | (e) (e) (e) (e) |P=0.511N P=0.503N P=0.289 P=0.506N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.505N (e) P=0.315 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.501N P=0.500N P=0.301 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.265N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 3/49 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.44 0/45.17 0/39.67 0/47.85 |1/45.04 0/44.73 3/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 0.0% 7.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/36 (0%) 0/27 (0%) 0/41 (0%) |1/34 (3%) 0/33 (0%) 3/35 (9%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |735 (T) --- 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.505N P=0.506N P=0.315 P=0.506N |
|POLY 3 | (e) (e) (e) (e) |P=0.508N P=0.501N P=0.288 P=0.504N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.505N P=0.501N P=0.291 P=0.502N |
|POLY 6 | (e) (e) (e) (e) |P=0.511N P=0.503N P=0.289 P=0.506N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.505N (e) P=0.315 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.501N P=0.500N P=0.301 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.265N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |25/50 (50%) 27/50 (54%) 21/49 (43%) 21/50 (42%) |
|POLY-3 RATE (b) | 2/44.52 2/45.17 2/39.67 1/47.85 |25/46.40 27/45.60 21/44.76 21/45.66 |
|POLY-3 PERCENT (g) | 4.5% 4.4% 5.0% 2.1% |53.9% 59.2% 46.9% 46.0% |
|TERMINAL (d) | 1/29 (3%) 2/36 (6%) 2/27 (7%) 1/41 (2%) |18/34 (53%) 22/33 (67%) 15/35 (43%) 16/33 (49%) |
|FIRST INCIDENCE | 710 731 (T) 731 (T) 731 (T) |649 675 470 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.283N P=0.624N P=0.657 P=0.396N |P=0.199N P=0.368 P=0.279N P=0.339N |
|POLY 3 | P=0.351N P=0.689N P=0.652 P=0.475N |P=0.162N P=0.378 P=0.323N P=0.289N |
|POLY 1.5 | P=0.361N P=0.694 P=0.665 P=0.486N |P=0.160N P=0.395 P=0.320N P=0.282N |
|POLY 6 | P=0.336N P=0.680N P=0.636 P=0.459N |P=0.164N P=0.344 P=0.316N P=0.303N |
|LOGISTIC REGRESSION| P=0.311N P=0.664N P=0.628 P=0.444N |P=0.183N P=0.388 P=0.343N P=0.302N |
|COCH-ARM / FISHERS | P=0.373N P=0.691N P=0.691N P=0.500N |P=0.160N P=0.421 P=0.305N P=0.274N |
|ORDER RESTRICTED | P=0.415N (e) (e) (e) |P=0.239N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |25/50 (50%) 27/50 (54%) 21/49 (43%) 21/50 (42%) |
|POLY-3 RATE (b) | 2/44.52 2/45.17 2/39.67 1/47.85 |25/46.40 27/45.60 21/44.76 21/45.66 |
|POLY-3 PERCENT (g) | 4.5% 4.4% 5.0% 2.1% |53.9% 59.2% 46.9% 46.0% |
|TERMINAL (d) | 1/29 (3%) 2/36 (6%) 2/27 (7%) 1/41 (2%) |18/34 (53%) 22/33 (67%) 15/35 (43%) 16/33 (49%) |
|FIRST INCIDENCE | 710 731 (T) 731 (T) 731 (T) |649 675 470 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.283N P=0.624N P=0.657 P=0.396N |P=0.199N P=0.368 P=0.279N P=0.339N |
|POLY 3 | P=0.351N P=0.689N P=0.652 P=0.475N |P=0.162N P=0.378 P=0.323N P=0.289N |
|POLY 1.5 | P=0.361N P=0.694 P=0.665 P=0.486N |P=0.160N P=0.395 P=0.320N P=0.282N |
|POLY 6 | P=0.336N P=0.680N P=0.636 P=0.459N |P=0.164N P=0.344 P=0.316N P=0.303N |
|LOGISTIC REGRESSION| P=0.311N P=0.664N P=0.628 P=0.444N |P=0.183N P=0.388 P=0.343N P=0.302N |
|COCH-ARM / FISHERS | P=0.373N P=0.691N P=0.691N P=0.500N |P=0.160N P=0.421 P=0.305N P=0.274N |
|ORDER RESTRICTED | P=0.415N (e) (e) (e) |P=0.239N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |26/50 (52%) 27/50 (54%) 23/49 (47%) 21/50 (42%) |
|POLY-3 RATE (b) | 2/44.52 2/45.17 2/39.67 1/47.85 |26/46.40 27/45.60 23/44.76 21/45.66 |
|POLY-3 PERCENT (g) | 4.5% 4.4% 5.0% 2.1% |56.0% 59.2% 51.4% 46.0% |
|TERMINAL (d) | 1/29 (3%) 2/36 (6%) 2/27 (7%) 1/41 (2%) |19/34 (56%) 22/33 (67%) 17/35 (49%) 16/33 (49%) |
|FIRST INCIDENCE | 710 731 (T) 731 (T) 731 (T) |649 675 470 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.283N P=0.624N P=0.657 P=0.396N |P=0.169N P=0.439 P=0.340N P=0.275N |
|POLY 3 | P=0.351N P=0.689N P=0.652 P=0.475N |P=0.133N P=0.461 P=0.406N P=0.222N |
|POLY 1.5 | P=0.361N P=0.694 P=0.665 P=0.486N |P=0.132N P=0.476 P=0.401N P=0.217N |
|POLY 6 | P=0.336N P=0.680N P=0.636 P=0.459N |P=0.133N P=0.427 P=0.400N P=0.232N |
|LOGISTIC REGRESSION| P=0.311N P=0.664N P=0.628 P=0.444N |P=0.154N P=0.470 P=0.430N P=0.236N |
|COCH-ARM / FISHERS | P=0.373N P=0.691N P=0.691N P=0.500N |P=0.133N P=0.500 P=0.381N P=0.212N |
|ORDER RESTRICTED | P=0.415N (e) (e) (e) |P=0.198N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.52 0/45.17 2/40.46 0/47.85 |0/45.04 1/44.73 1/43.34 0/44.16 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 4.9% 0.0% |0.0% 2.2% 2.3% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/36 (0%) 0/27 (0%) 0/41 (0%) |0/34 (0%) 1/33 (3%) 0/35 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 710 --- 535 --- |--- 735 (T) 632 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.438N P=0.478N P=0.443 P=0.458N |P=0.598N P=0.494 P=0.486 (e) |
|POLY 3 | P=0.439N P=0.497N P=0.467 P=0.486N |P=0.600N P=0.499 P=0.492 (e) |
|POLY 1.5 | P=0.448N P=0.500N P=0.476 P=0.492N |P=0.598N P=0.499 P=0.493 (e) |
|POLY 6 | P=0.429N P=0.492N P=0.456 P=0.476N |P=0.602N P=0.497 P=0.494 (e) |
|LOGISTIC REGRESSION| P=0.476N P=0.498N P=0.553 P=0.498N |P=0.593N P=0.494 P=0.510 (e) |
|COCH-ARM / FISHERS | P=0.461N P=0.500N P=0.500 P=0.500N |P=0.595N P=0.500 P=0.495 (e) |
|ORDER RESTRICTED | P=0.301N (e) (e) (e) |P=0.396 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 2/48 (4%) 0/46 (0%) 0/42 (0%) |0/47 (0%) 0/48 (0%) 0/46 (0%) 0/46 (0%) |
|POLY-3 RATE (b) | 0/41.75 2/43.75 0/36.37 0/40.10 |0/42.43 0/43.29 0/40.57 0/41.76 |
|POLY-3 PERCENT (g) | 0.0% 4.6% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 1/35 (3%) 0/24 (0%) 0/34 (0%) |0/32 (0%) 0/32 (0%) 0/33 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- 682 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.387N P=0.270 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.421N P=0.248 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.427N P=0.243 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.410N P=0.255 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.423N P=0.243 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.428N P=0.253 (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.264N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 10/50 (20%) 10/50 (20%) 8/50 (16%) |19/50 (38%) 18/50 (36%) 15/49 (31%) 17/50 (34%) |
|POLY-3 RATE (b) | 13/45.01 10/45.75 10/42.45 8/48.01 |19/46.79 18/45.62 15/43.94 17/46.59 |
|POLY-3 PERCENT (g) | 28.9% 21.9% 23.6% 16.7% |40.6% 39.5% 34.1% 36.5% |
|TERMINAL (d) | 10/29 (35%) 7/36 (19%) 3/27 (11%) 7/41 (17%) |14/34 (41%) 14/33 (42%) 11/35 (31%) 10/33 (30%) |
|FIRST INCIDENCE | 631 591 488 691 |557 626 610 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.064N P=0.169N P=0.440N P=0.037N* |P=0.393N P=0.538N P=0.265N P=0.467N |
|POLY 3 | P=0.115N P=0.299N P=0.373N P=0.122N |P=0.354N P=0.540N P=0.337N P=0.422N |
|POLY 1.5 | P=0.130N P=0.315N P=0.363N P=0.139N |P=0.357N P=0.525N P=0.322N P=0.422N |
|POLY 6 | P=0.097N P=0.273N P=0.379N P=0.100N |P=0.343N P=0.564N P=0.342N P=0.417N |
|LOGISTIC REGRESSION| P=0.138N P=0.283N P=0.354N P=0.090N |P=0.372N P=0.508N P=0.310N P=0.420N |
|COCH-ARM / FISHERS | P=0.150N P=0.318N P=0.318N P=0.163N |P=0.356N P=0.500N P=0.287N P=0.418N |
|ORDER RESTRICTED | P=0.116N (e) (e) (e) |P=0.469N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or |
| Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.44 3/45.47 0/39.67 0/47.85 |0/45.04 0/44.73 0/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 0.0% 6.6% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 2/36 (6%) 0/27 (0%) 0/41 (0%) |0/34 (0%) 0/33 (0%) 0/35 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 648 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.270N P=0.152 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.294N P=0.123 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.303N P=0.120 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.277N P=0.129 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.306N P=0.121 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.311N P=0.121 (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.154N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.93 4/45.47 0/39.67 0/47.85 |0/45.04 1/44.73 0/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 2.2% 8.8% 0.0% 0.0% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 3/36 (8%) 0/27 (0%) 0/41 (0%) |0/34 (0%) 1/33 (3%) 0/35 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 586 648 --- --- |--- 735 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.104N P=0.228 P=0.527N P=0.492N |P=0.570N P=0.494 (e) (e) |
|POLY 3 | P=0.115N P=0.182 P=0.525N P=0.487N |P=0.570N P=0.499 (e) (e) |
|POLY 1.5 | P=0.120N P=0.178 P=0.517N P=0.493N |P=0.569N P=0.499 (e) (e) |
|POLY 6 | P=0.108N P=0.190 P=0.534N P=0.479N |P=0.571N P=0.497 (e) (e) |
|LOGISTIC REGRESSION| P=0.125N P=0.182 P=0.420N P=0.620N |(e) P=0.494 (e) (e) |
|COCH-ARM / FISHERS | P=0.125N P=0.181 P=0.500N P=0.500N |P=0.567N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.071N (e) (e) (e) |P=0.383N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|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%) 6/50 (12%) 4/50 (8%) 0/50 (0%) |0/50 (0%) 3/50 (6%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/45.06 6/45.47 4/39.81 0/47.85 |0/45.04 3/45.20 0/42.98 1/44.16 |
|POLY-3 PERCENT (g) | 8.9% 13.2% 10.1% 0.0% |0.0% 6.6% 0.0% 2.3% |
|TERMINAL (d) | 2/29 (7%) 5/36 (14%) 3/27 (11%) 0/41 (0%) |0/34 (0%) 2/33 (6%) 0/35 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 586 648 695 --- |--- 597 --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.022N* P=0.472 P=0.567 P=0.041N* |P=0.626 P=0.121 (e) P=0.494 |
|POLY 3 | P=0.029N* P=0.375 P=0.574 P=0.053N |P=0.626 P=0.119 (e) P=0.496 |
|POLY 1.5 | P=0.032N* P=0.368 P=0.596 P=0.056N |P=0.628 P=0.119 (e) P=0.498 |
|POLY 6 | P=0.025N* P=0.389 P=0.546 P=0.049N* |P=0.623 P=0.119 (e) P=0.494 |
|LOGISTIC REGRESSION| P=0.034N* P=0.370 P=0.582 P=0.079N |P=0.632 P=0.121 (e) P=0.494 |
|COCH-ARM / FISHERS | P=0.037N* P=0.370 P=0.643N P=0.059N |P=0.633 P=0.121 (e) P=0.500 |
|ORDER RESTRICTED | P=0.028N* (e) (e) (e) |P=0.263 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.52 1/45.17 2/39.87 4/48.20 |0/45.04 0/44.73 0/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 2.3% 2.2% 5.0% 8.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/36 (3%) 1/27 (4%) 2/41 (5%) |0/34 (0%) 0/33 (0%) 0/35 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 711 731 (T) 676 672 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123 P=0.720N P=0.451 P=0.268 |(e) (e) (e) (e) |
|POLY 3 | P=0.083 P=0.757N P=0.462 P=0.204 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.078 P=0.760 P=0.473 P=0.193 |(e) (e) (e) (e) |
|POLY 6 | P=0.091 P=0.752N P=0.448 P=0.222 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.083 P=0.751N P=0.457 P=0.174 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.072 P=0.753N P=0.500 P=0.181 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.115 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 3/50 (6%) 7/50 (14%) |0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/45.39 3/45.36 3/39.95 7/48.89 |0/45.04 0/44.73 1/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 11.0% 6.6% 7.5% 14.3% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 1/29 (3%) 2/36 (6%) 1/27 (4%) 4/41 (10%) |0/34 (0%) 0/33 (0%) 1/35 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 603 682 676 499 |--- --- 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.349 P=0.303N P=0.447N P=0.538 |P=0.693 (e) P=0.506 (e) |
|POLY 3 | P=0.254 P=0.357N P=0.428N P=0.432 |P=0.687 (e) P=0.491 (e) |
|POLY 1.5 | P=0.242 P=0.361N P=0.404N P=0.410 |P=0.690 (e) P=0.492 (e) |
|POLY 6 | P=0.272 P=0.348N P=0.458N P=0.463 |P=0.684 (e) P=0.491 (e) |
|LOGISTIC REGRESSION| P=0.224 P=0.354N P=0.381N P=0.239 |(e) (e) P=0.506 (e) |
|COCH-ARM / FISHERS | P=0.226 P=0.357N P=0.357N P=0.380 |P=0.694 (e) P=0.495 (e) |
|ORDER RESTRICTED | P=0.261 (e) (e) (e) |P=0.372 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/45.31 1/45.17 0/39.67 1/47.85 |0/45.04 0/44.73 1/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 8.8% 2.2% 0.0% 2.1% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/36 (3%) 0/27 (0%) 1/41 (2%) |0/34 (0%) 0/33 (0%) 1/35 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 603 731 (T) --- 731 (T) |--- --- 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.085N P=0.157N P=0.094N P=0.127N |P=0.693 (e) P=0.506 (e) |
|POLY 3 | P=0.103N P=0.179N P=0.079N P=0.163N |P=0.687 (e) P=0.491 (e) |
|POLY 1.5 | P=0.103N P=0.182N P=0.072N P=0.170N |P=0.690 (e) P=0.492 (e) |
|POLY 6 | P=0.102N P=0.175N P=0.088N P=0.153N |P=0.684 (e) P=0.491 (e) |
|LOGISTIC REGRESSION| P=0.103N P=0.174N P=0.054N P=0.232N |(e) (e) P=0.506 (e) |
|COCH-ARM / FISHERS | P=0.104N P=0.181N P=0.059N P=0.181N |P=0.694 (e) P=0.495 (e) |
|ORDER RESTRICTED | P=0.023N* (e) (e) (e) |P=0.372 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/45.31 3/45.36 1/39.74 3/48.53 |0/45.04 0/44.73 1/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 8.8% 6.6% 2.5% 6.2% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 1/29 (3%) 2/36 (6%) 0/27 (0%) 2/41 (5%) |0/34 (0%) 0/33 (0%) 1/35 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 603 682 713 499 |--- --- 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.315N P=0.444N P=0.238N P=0.395N |P=0.693 (e) P=0.506 (e) |
|POLY 3 | P=0.382N P=0.499N P=0.221N P=0.463N |P=0.687 (e) P=0.491 (e) |
|POLY 1.5 | P=0.390N P=0.504N P=0.206N P=0.478N |P=0.690 (e) P=0.492 (e) |
|POLY 6 | P=0.372N P=0.491N P=0.240N P=0.442N |P=0.684 (e) P=0.491 (e) |
|LOGISTIC REGRESSION| P=0.405N P=0.497N P=0.176N P=0.649 |(e) (e) P=0.506 (e) |
|COCH-ARM / FISHERS | P=0.397N P=0.500N P=0.181N P=0.500N |P=0.694 (e) P=0.495 (e) |
|ORDER RESTRICTED | P=0.299N (e) (e) (e) |P=0.372 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.44 2/45.36 1/39.74 1/47.85 |0/45.04 0/44.73 0/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 2.5% 2.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/36 (3%) 0/27 (0%) 1/41 (2%) |0/34 (0%) 0/33 (0%) 0/35 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 682 713 731 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.570 P=0.269 P=0.486 P=0.569 |(e) (e) (e) (e) |
|POLY 3 | P=0.533 P=0.242 P=0.478 P=0.515 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.518 P=0.238 P=0.485 P=0.508 |(e) (e) (e) (e) |
|POLY 6 | P=0.556 P=0.249 P=0.470 P=0.524 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.522 P=0.238 P=0.470 P=0.569 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.500 P=0.247 P=0.500 P=0.500 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.256 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/44.58 3/45.17 3/39.81 0/47.85 |0/45.04 2/45.20 0/42.98 1/44.16 |
|POLY-3 PERCENT (g) | 6.7% 6.6% 7.5% 0.0% |0.0% 4.4% 0.0% 2.3% |
|TERMINAL (d) | 2/29 (7%) 3/36 (8%) 2/27 (7%) 0/41 (0%) |0/34 (0%) 1/33 (3%) 0/35 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 696 731 (T) 695 --- |--- 597 --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.061N P=0.577N P=0.594 P=0.078N |P=0.531 P=0.239 (e) P=0.494 |
|POLY 3 | P=0.079N P=0.656N P=0.609 P=0.107N |P=0.531 P=0.238 (e) P=0.496 |
|POLY 1.5 | P=0.085N P=0.662 P=0.626 P=0.112N |P=0.534 P=0.237 (e) P=0.498 |
|POLY 6 | P=0.071N P=0.646N P=0.590 P=0.099N |P=0.529 P=0.238 (e) P=0.494 |
|LOGISTIC REGRESSION| P=0.076N P=0.626N P=0.581 P=0.100N |P=0.540 P=0.242 (e) P=0.494 |
|COCH-ARM / FISHERS | P=0.092N P=0.661N P=0.661N P=0.121N |P=0.539 P=0.247 (e) P=0.500 |
|ORDER RESTRICTED | P=0.092N (e) (e) (e) |P=0.321 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/44.58 3/45.17 4/39.81 0/47.85 |0/45.04 2/45.20 0/42.98 1/44.16 |
|POLY-3 PERCENT (g) | 6.7% 6.6% 10.1% 0.0% |0.0% 4.4% 0.0% 2.3% |
|TERMINAL (d) | 2/29 (7%) 3/36 (8%) 3/27 (11%) 0/41 (0%) |0/34 (0%) 1/33 (3%) 0/35 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 696 731 (T) 695 --- |--- 597 --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.073N P=0.577N P=0.428 P=0.078N |P=0.531 P=0.239 (e) P=0.494 |
|POLY 3 | P=0.094N P=0.656N P=0.438 P=0.107N |P=0.531 P=0.238 (e) P=0.496 |
|POLY 1.5 | P=0.102N P=0.662 P=0.458 P=0.112N |P=0.534 P=0.237 (e) P=0.498 |
|POLY 6 | P=0.084N P=0.646N P=0.416 P=0.099N |P=0.529 P=0.238 (e) P=0.494 |
|LOGISTIC REGRESSION| P=0.091N P=0.626N P=0.401 P=0.100N |P=0.540 P=0.242 (e) P=0.494 |
|COCH-ARM / FISHERS | P=0.114N P=0.661N P=0.500 P=0.121N |P=0.539 P=0.247 (e) P=0.500 |
|ORDER RESTRICTED | P=0.074N (e) (e) (e) |P=0.321 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.44 3/45.47 0/39.67 0/47.85 |0/45.04 0/44.73 0/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 0.0% 6.6% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 2/36 (6%) 0/27 (0%) 0/41 (0%) |0/34 (0%) 0/33 (0%) 0/35 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 648 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.270N P=0.152 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.294N P=0.123 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.303N P=0.120 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.277N P=0.129 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.306N P=0.121 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.311N P=0.121 (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.154N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 47/49 (96%) 42/50 (84%) 50/50 (100%)| |
|POLY-3 RATE (b) | 45/49.43 47/47.18 42/45.94 50/50.00 | |
|POLY-3 PERCENT (g) | 91.0% 99.6% 91.4% 100.0% | |
|TERMINAL (d) | 27/29 (93%) 36/36 (100%) 26/27 (96%) 41/41 (100%)| |
|FIRST INCIDENCE | 508 591 506 499 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.114N P=0.203N P=0.457 P=0.080N | |
|POLY 3 | P=0.054 P=0.053 P=0.625 P=0.037 * | |
|POLY 1.5 | P=0.059 P=0.071 P=0.567N P=0.033 * | |
|POLY 6 | P=0.053 P=0.054 P=0.537 P=0.045 * | |
|LOGISTIC REGRESSION| P=0.107 P=0.127 P=0.582N P=0.036 * | |
|COCH-ARM / FISHERS | P=0.093 P=0.226 P=0.277N P=0.028 * | |
|ORDER RESTRICTED | P=0.009 ** (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 10/50 (20%) 3/50 (6%) 10/50 (20%) |5/50 (10%) 3/49 (6%) 4/49 (8%) 5/50 (10%) |
|POLY-3 RATE (b) | 4/44.44 10/45.74 3/40.17 10/48.06 |5/45.15 3/44.88 4/42.98 5/44.16 |
|POLY-3 PERCENT (g) | 9.0% 21.9% 7.5% 20.8% |11.1% 6.7% 9.3% 11.3% |
|TERMINAL (d) | 4/29 (14%) 6/36 (17%) 2/27 (7%) 9/41 (22%) |4/34 (12%) 1/33 (3%) 4/35 (11%) 5/33 (15%) |
|FIRST INCIDENCE | 731 (T) 648 577 675 |708 626 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.300 P=0.146 P=0.542N P=0.212 |P=0.472 P=0.375N P=0.484N P=0.612 |
|POLY 3 | P=0.164 P=0.079 P=0.555N P=0.097 |P=0.466 P=0.360N P=0.531N P=0.617 |
|POLY 1.5 | P=0.150 P=0.074 P=0.539N P=0.086 |P=0.474 P=0.364N P=0.526N P=0.622 |
|POLY 6 | P=0.189 P=0.091 P=0.573N P=0.116 |P=0.457 P=0.355N P=0.531N P=0.610 |
|LOGISTIC REGRESSION| P=0.190 P=0.087 P=0.574N P=0.144 |P=0.466 P=0.367N P=0.506N P=0.615 |
|COCH-ARM / FISHERS | P=0.139 P=0.074 P=0.500N P=0.074 |P=0.486 P=0.369N P=0.513N P=0.630N |
|ORDER RESTRICTED | P=0.078 (e) (e) (e) |P=0.546 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |3/50 (6%) 0/49 (0%) 3/49 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.53 1/45.17 1/39.67 1/48.10 |3/45.09 0/44.29 3/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 2.3% 2.2% 2.5% 2.1% |6.7% 0.0% 7.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/36 (3%) 1/27 (4%) 0/41 (0%) |2/34 (6%) 0/33 (0%) 3/35 (9%) 0/33 (0%) |
|FIRST INCIDENCE | 709 731 (T) 731 (T) 666 |723 --- 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.567N P=0.730N P=0.724 P=0.723N |P=0.166N P=0.132N P=0.651N P=0.128N |
|POLY 3 | P=0.619N P=0.758N P=0.734 P=0.743N |P=0.167N P=0.122N P=0.640 P=0.122N |
|POLY 1.5 | P=0.626N P=0.760 P=0.743 P=0.751N |P=0.165N P=0.122N P=0.643 P=0.121N |
|POLY 6 | P=0.609N P=0.752N P=0.724 P=0.731N |P=0.169N P=0.122N P=0.641 P=0.124N |
|LOGISTIC REGRESSION| P=0.618N P=0.753N P=0.723 P=0.734 |P=0.165N P=0.125N P=0.665N P=0.125N |
|COCH-ARM / FISHERS | P=0.634 P=0.753N P=0.753N P=0.753N |P=0.163N P=0.125N P=0.651 P=0.121N |
|ORDER RESTRICTED | P=0.711N (e) (e) (e) |P=0.057N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 11/50 (22%) 4/50 (8%) 11/50 (22%) |8/50 (16%) 3/49 (6%) 7/49 (14%) 5/50 (10%) |
|POLY-3 RATE (b) | 5/44.53 11/45.74 4/40.17 11/48.31 |8/45.20 3/44.88 7/42.98 5/44.16 |
|POLY-3 PERCENT (g) | 11.2% 24.1% 10.0% 22.8% |17.7% 6.7% 16.3% 11.3% |
|TERMINAL (d) | 4/29 (14%) 7/36 (19%) 3/27 (11%) 9/41 (22%) |6/34 (18%) 1/33 (3%) 7/35 (20%) 5/33 (15%) |
|FIRST INCIDENCE | 709 648 577 666 |708 626 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.333 P=0.170 P=0.560N P=0.244 |P=0.380N P=0.118N P=0.479N P=0.296N |
|POLY 3 | P=0.185 P=0.092 P=0.564N P=0.115 |P=0.388N P=0.100N P=0.542N P=0.290N |
|POLY 1.5 | P=0.168 P=0.086 P=0.545N P=0.101 |P=0.378N P=0.103N P=0.535N P=0.285N |
|POLY 6 | P=0.216 P=0.104 P=0.587N P=0.139 |P=0.398N P=0.097N P=0.544N P=0.297N |
|LOGISTIC REGRESSION| P=0.206 P=0.101 P=0.591N P=0.135 |P=0.388N P=0.106N P=0.506N P=0.290N |
|COCH-ARM / FISHERS | P=0.153 P=0.086 P=0.500N P=0.086 |P=0.365N P=0.106N P=0.517N P=0.277N |
|ORDER RESTRICTED | P=0.100 (e) (e) (e) |P=0.292N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.89 1/45.17 0/39.67 0/47.85 |0/45.04 0/44.29 0/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 4.5% 2.2% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/36 (3%) 0/27 (0%) 0/41 (0%) |0/34 (0%) 0/33 (0%) 0/35 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 631 731 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.092N P=0.464N P=0.295N P=0.207N |(e) (e) (e) (e) |
|POLY 3 | P=0.101N P=0.498N P=0.266N P=0.223N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.102N P=0.502N P=0.256N P=0.229N |(e) (e) (e) (e) |
|POLY 6 | P=0.101N P=0.491N P=0.278N P=0.215N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.100N P=0.498N P=0.224N P=0.290N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.066N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |7/50 (14%) 8/50 (16%) 8/49 (16%) 12/50 (24%) |
|POLY-3 RATE (b) | |7/45.35 8/45.44 8/43.68 12/44.96 |
|POLY-3 PERCENT (g) | |15.4% 17.6% 18.3% 26.7% |
|TERMINAL (d) | |6/34 (18%) 6/33 (18%) 6/35 (17%) 10/33 (30%) |
|FIRST INCIDENCE | |649 597 543 564 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.101 P=0.481 P=0.511 P=0.136 |
|POLY 3 | |P=0.101 P=0.502 P=0.468 P=0.145 |
|POLY 1.5 | |P=0.104 P=0.500 P=0.471 P=0.148 |
|POLY 6 | |P=0.099 P=0.501 P=0.473 P=0.141 |
|LOGISTIC REGRESSION| |P=0.101 P=0.495 P=0.465 P=0.141 |
|COCH-ARM / FISHERS | |P=0.109 P=0.500 P=0.483 P=0.154 |
|ORDER RESTRICTED | |P=0.135 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 15/50 (30%) 21/50 (42%) 9/50 (18%) |9/50 (18%) 8/50 (16%) 7/49 (14%) 9/50 (18%) |
|POLY-3 RATE (b) | 22/47.65 15/47.08 21/45.35 9/48.49 |9/47.27 8/46.60 7/44.76 9/46.19 |
|POLY-3 PERCENT (g) | 46.2% 31.9% 46.3% 18.6% |19.0% 17.2% 15.6% 19.5% |
|TERMINAL (d) | 10/29 (35%) 8/36 (22%) 7/27 (26%) 6/41 (15%) |2/34 (6%) 2/33 (6%) 2/35 (6%) 3/33 (9%) |
|FIRST INCIDENCE | 524 593 506 633 |203 561 459 564 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006N** P=0.068N P=0.453 P<0.001N** |P=0.509 P=0.521N P=0.422N P=0.568 |
|POLY 3 | P=0.006N** P=0.110N P=0.578 P=0.003N** |P=0.516 P=0.513N P=0.439N P=0.582 |
|POLY 1.5 | P=0.006N** P=0.114N P=0.576N P=0.003N** |P=0.520 P=0.513N P=0.434N P=0.585 |
|POLY 6 | P=0.005N** P=0.100N P=0.580 P=0.002N** |P=0.515 P=0.515N P=0.437N P=0.580 |
|LOGISTIC REGRESSION| P=0.011N* P=0.105N P=0.440N P=0.010N* |P=0.544N P=0.484N P=0.350N P=0.574N |
|COCH-ARM / FISHERS | P=0.009N** P=0.107N P=0.500N P=0.004N** |P=0.536 P=0.500N P=0.410N P=0.602N |
|ORDER RESTRICTED | P=0.002N** (e) (e) (e) |P=0.609 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/44.60 5/45.39 0/39.67 1/47.85 |0/45.04 0/44.73 0/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 6.7% 11.0% 0.0% 2.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 4/36 (11%) 0/27 (0%) 1/41 (2%) |0/34 (0%) 0/33 (0%) 0/35 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 690 672 --- 731 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.062N P=0.452 P=0.149N P=0.209N |(e) (e) (e) (e) |
|POLY 3 | P=0.084N P=0.366 P=0.141N P=0.281N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.088N P=0.357 P=0.134N P=0.292N |(e) (e) (e) (e) |
|POLY 6 | P=0.077N P=0.381 P=0.150N P=0.265N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.079N P=0.378 P=0.150N P=0.261N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.092N P=0.357 P=0.121N P=0.309N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.059N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/44.60 5/45.39 0/39.67 1/47.85 |0/45.04 0/44.73 0/42.98 0/44.16 |
|POLY-3 PERCENT (g) | 6.7% 11.0% 0.0% 2.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 4/36 (11%) 0/27 (0%) 1/41 (2%) |0/34 (0%) 0/33 (0%) 0/35 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 690 672 --- 731 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.062N P=0.452 P=0.149N P=0.209N |(e) (e) (e) (e) |
|POLY 3 | P=0.084N P=0.366 P=0.141N P=0.281N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.088N P=0.357 P=0.134N P=0.292N |(e) (e) (e) (e) |
|POLY 6 | P=0.077N P=0.381 P=0.150N P=0.265N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.079N P=0.378 P=0.150N P=0.261N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.092N P=0.357 P=0.121N P=0.309N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.059N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 48/50 (96%) 48/50 (96%) 50/50 (100%)|39/50 (78%) 37/50 (74%) 38/49 (78%) 38/50 (76%) |
|POLY-3 RATE (b) | 50/50.00 48/48.18 48/48.02 50/50.00 |39/47.85 37/47.12 38/46.15 38/47.77 |
|POLY-3 PERCENT (g) | 100.0% 99.6% 100.0% 100.0% |81.5% 78.5% 82.4% 79.6% |
|TERMINAL (d) | 29/29 (100%) 36/36 (100%) 27/27 (100%) 41/41 (100%)|28/34 (82%) 27/33 (82%) 29/35 (83%) 26/33 (79%) |
|FIRST INCIDENCE | 508 591 488 499 |557 597 470 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029N* P=0.059N P=0.352 (e) |P=0.505 P=0.504N P=0.475N P=0.555 |
|POLY 3 | P=1.000 P=1.000N P=1.000N (e) |P=0.502N P=0.455N P=0.566 P=0.506N |
|POLY 1.5 | P=0.842 P=0.864N P=1.000N (e) |P=0.508N P=0.440N P=0.578 P=0.507N |
|POLY 6 | P=1.000 P=1.000N P=1.000N (e) |P=0.484N P=0.488N P=0.575 P=0.503N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.530 P=0.414N P=0.534 P=0.539N |
|COCH-ARM / FISHERS | P=0.500 P=0.247N P=0.247N (e) |P=0.509N P=0.408N P=0.574N P=0.500N |
|ORDER RESTRICTED | P=0.353 (e) (e) (e) |P=0.623N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/10/02 EXPERIMENT: 56111 TEST: 03 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 27/50 (54%) 27/50 (54%) 19/50 (38%) |21/50 (42%) 14/50 (28%) 16/49 (33%) 13/50 (26%) |
|POLY-3 RATE (b) | 30/48.60 27/48.54 27/46.31 19/49.63 |21/48.39 14/47.45 16/45.45 13/46.64 |
|POLY-3 PERCENT (g) | 61.7% 55.6% 58.3% 38.3% |43.4% 29.5% 35.2% 27.9% |
|TERMINAL (d) | 14/29 (48%) 15/36 (42%) 10/27 (37%) 13/41 (32%) |10/34 (29%) 5/33 (15%) 10/35 (29%) 4/33 (12%) |
|FIRST INCIDENCE | 524 404 506 499 |203 561 459 564 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.008N** P=0.188N P=0.523 P=0.004N** |P=0.142N P=0.160N P=0.244N P=0.123N |
|POLY 3 | P=0.011N* P=0.343N P=0.448N P=0.015N* |P=0.110N P=0.114N P=0.274N P=0.084N |
|POLY 1.5 | P=0.012N* P=0.357N P=0.434N P=0.017N* |P=0.105N P=0.114N P=0.262N P=0.080N |
|POLY 6 | P=0.009N** P=0.319N P=0.450N P=0.013N* |P=0.116N P=0.116N P=0.285N P=0.090N |
|LOGISTIC REGRESSION| P=0.021N* P=0.342N P=0.316N P=0.067N |P=0.085N P=0.096N P=0.202N P=0.059N |
|COCH-ARM / FISHERS | P=0.017N* P=0.343N P=0.343N P=0.022N* |P=0.093N P=0.104N P=0.226N P=0.069N |
|ORDER RESTRICTED | P=0.011N* (e) (e) (e) |P=0.080N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 49/50 (98%) 48/50 (96%) 50/50 (100%)|45/50 (90%) 42/50 (84%) 44/49 (90%) 42/50 (84%) |
|POLY-3 RATE (b) | 50/50.00 49/49.01 48/48.02 50/50.00 |45/50.00 42/48.93 44/48.01 42/48.81 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% |90.0% 85.8% 91.6% 86.1% |
|TERMINAL (d) | 29/29 (100%) 36/36 (100%) 27/27 (100%) 41/41 (100%)|29/34 (85%) 27/33 (82%) 31/35 (89%) 27/33 (82%) |
|FIRST INCIDENCE | 508 404 488 499 |203 561 459 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.026N* P=0.087N P=0.352 (e) |P=0.453N P=0.444N P=0.487N P=0.460N |
|POLY 3 | P=1.000 P=1.000N P=1.000N (e) |P=0.401N P=0.372N P=0.527 P=0.384N |
|POLY 1.5 | P=1.000 P=1.000N P=1.000N (e) |P=0.381N P=0.365N P=0.540 P=0.365N |
|POLY 6 | P=1.000 P=1.000N P=1.000N (e) |P=0.419N P=0.378N P=0.525 P=0.402N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.320N P=0.281N P=0.631 P=0.281N |
|COCH-ARM / FISHERS | P=0.616 P=0.500N P=0.247N (e) |P=0.308N P=0.277N P=0.617N P=0.277N |
|ORDER RESTRICTED | P=0.353 (e) (e) (e) |P=0.427N (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).