TDMS Study 56111-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRANS-CINNAMALDEHYDE DATE: 06/18/01
EXPERIMENT: 56111 TEST: 03 TIME: 13:34:00
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: 06/18/01
EXPERIMENT: 56111 TEST: 03 TIME: 13:34:00
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
Skin Fibroma
===============================================================
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/44.44 0/41.64 | 0/45.04 1/45.91 |
|POLY-3 PERCENT (g) | 11.3% 0.0% | 0.0% 2.2% |
|TERMINAL (d) | 5/29 (17%) 0/31 (0%) | 0/34 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 731 (T) --- | --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.027N* | P=0.511 |
|POLY 3 | P=0.037N* | P=0.500 |
|POLY 1.5 | P=0.035N* | P=0.500 |
|POLY 6 | P=0.040N* | P=0.500 |
|LOGISTIC REGRESSION| (e) | P=0.511 |
|COCH-ARM / FISHERS | P=0.028N* | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) | 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 5/44.44 0/41.64 | 1/45.04 3/46.09 |
|POLY-3 PERCENT (g) | 11.3% 0.0% | 2.2% 6.5% |
|TERMINAL (d) | 5/29 (17%) 0/31 (0%) | 1/34 (3%) 2/36 (6%) |
|FIRST INCIDENCE | 731 (T) --- | 735 (T) 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.027N* | P=0.324 |
|POLY 3 | P=0.037N* | P=0.311 |
|POLY 1.5 | P=0.035N* | P=0.310 |
|POLY 6 | P=0.040N* | P=0.313 |
|LOGISTIC REGRESSION| (e) | P=0.313 |
|COCH-ARM / FISHERS | P=0.028N* | P=0.309 |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) | 4/49 (8%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.58 5/42.15 | 4/44.09 0/45.91 |
|POLY-3 PERCENT (g) | 4.5% 11.9% | 9.1% 0.0% |
|TERMINAL (d) | 1/29 (3%) 4/31 (13%) | 3/33 (9%) 0/36 (0%) |
|FIRST INCIDENCE | 696 577 | 723 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.226 | P=0.056N |
|POLY 3 | P=0.196 | P=0.054N |
|POLY 1.5 | P=0.204 | P=0.055N |
|POLY 6 | P=0.189 | P=0.053N |
|LOGISTIC REGRESSION| P=0.193 | P=0.054N |
|COCH-ARM / FISHERS | P=0.218 | P=0.056N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) | 3/49 (6%) 6/50 (12%) |
|POLY-3 RATE (b) | 3/44.44 1/41.64 | 3/44.55 6/46.28 |
|POLY-3 PERCENT (g) | 6.8% 2.4% | 6.7% 13.0% |
|TERMINAL (d) | 3/29 (10%) 1/31 (3%) | 1/33 (3%) 4/36 (11%) |
|FIRST INCIDENCE | 731 (T) 731 (T) | 597 683 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.280N | P=0.280 |
|POLY 3 | P=0.335N | P=0.259 |
|POLY 1.5 | P=0.323N | P=0.258 |
|POLY 6 | P=0.346N | P=0.261 |
|LOGISTIC REGRESSION| P=0.280N | P=0.253 |
|COCH-ARM / FISHERS | P=0.309N | P=0.254 |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 6/50 (12%) | 7/49 (14%) 6/50 (12%) |
|POLY-3 RATE (b) | 5/44.58 6/42.15 | 7/44.60 6/46.28 |
|POLY-3 PERCENT (g) | 11.2% 14.2% | 15.7% 13.0% |
|TERMINAL (d) | 4/29 (14%) 5/31 (16%) | 4/33 (12%) 4/36 (11%) |
|FIRST INCIDENCE | 696 577 | 597 683 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.525 | P=0.452N |
|POLY 3 | P=0.464 | P=0.469N |
|POLY 1.5 | P=0.478 | P=0.471N |
|POLY 6 | P=0.452 | P=0.466N |
|LOGISTIC REGRESSION| P=0.441 | P=0.472N |
|COCH-ARM / FISHERS | P=0.500 | P=0.484N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Heart |
| Schwannoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.44 2/41.64 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 0.0% 4.8% | 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 2/31 (7%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 731 (T) | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.253 | (e) |
|POLY 3 | P=0.230 | (e) |
|POLY 1.5 | P=0.233 | (e) |
|POLY 6 | P=0.228 | (e) |
|LOGISTIC REGRESSION| P=0.253 | (e) |
|COCH-ARM / FISHERS | P=0.247 | (e) |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.44 0/41.64 | 2/45.34 0/45.91 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 4.4% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/31 (0%) | 1/34 (3%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- | 652 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.231N |
|POLY 3 | (e) | P=0.233N |
|POLY 1.5 | (e) | P=0.233N |
|POLY 6 | (e) | P=0.233N |
|LOGISTIC REGRESSION| (e) | P=0.242N |
|COCH-ARM / FISHERS | (e) | P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.44 1/41.67 | 2/45.34 0/45.91 |
|POLY-3 PERCENT (g) | 2.3% 2.4% | 4.4% 0.0% |
|TERMINAL (d) | 1/29 (3%) 0/31 (0%) | 1/34 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 731 (T) 724 | 652 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.746N | P=0.231N |
|POLY 3 | P=0.754 | P=0.233N |
|POLY 1.5 | P=0.756 | P=0.233N |
|POLY 6 | P=0.752 | P=0.233N |
|LOGISTIC REGRESSION| P=0.751 | P=0.242N |
|COCH-ARM / FISHERS | P=0.753N | P=0.247N |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) | 2/50 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 2/44.65 2/41.64 | 2/45.04 4/45.91 |
|POLY-3 PERCENT (g) | 4.5% 4.8% | 4.4% 8.7% |
|TERMINAL (d) | 1/29 (3%) 2/31 (7%) | 2/34 (6%) 4/36 (11%) |
|FIRST INCIDENCE | 676 731 (T) | 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.693N | P=0.363 |
|POLY 3 | P=0.676 | P=0.345 |
|POLY 1.5 | P=0.683 | P=0.343 |
|POLY 6 | P=0.669 | P=0.346 |
|LOGISTIC REGRESSION| P=0.664 | P=0.363 |
|COCH-ARM / FISHERS | P=0.691N | P=0.339 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) | 3/50 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 2/44.65 3/41.92 | 3/45.04 4/45.91 |
|POLY-3 PERCENT (g) | 4.5% 7.2% | 6.7% 8.7% |
|TERMINAL (d) | 1/29 (3%) 2/31 (7%) | 3/34 (9%) 4/36 (11%) |
|FIRST INCIDENCE | 676 655 | 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.482 | P=0.532 |
|POLY 3 | P=0.477 | P=0.509 |
|POLY 1.5 | P=0.486 | P=0.507 |
|POLY 6 | P=0.470 | P=0.511 |
|LOGISTIC REGRESSION| P=0.473 | P=0.532 |
|COCH-ARM / FISHERS | P=0.500 | P=0.500 |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 25/50 (50%) 30/50 (60%) |
|POLY-3 RATE (b) | 2/44.52 1/42.07 | 25/46.40 30/47.49 |
|POLY-3 PERCENT (g) | 4.5% 2.4% | 53.9% 63.2% |
|TERMINAL (d) | 1/29 (3%) 0/31 (0%) | 18/34 (53%) 22/36 (61%) |
|FIRST INCIDENCE | 710 606 | 649 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.507N | P=0.322 |
|POLY 3 | P=0.527N | P=0.237 |
|POLY 1.5 | P=0.517N | P=0.232 |
|POLY 6 | P=0.536N | P=0.244 |
|LOGISTIC REGRESSION| P=0.491N | P=0.235 |
|COCH-ARM / FISHERS | P=0.500N | P=0.211 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 25/50 (50%) 30/50 (60%) |
|POLY-3 RATE (b) | 2/44.52 1/42.07 | 25/46.40 30/47.49 |
|POLY-3 PERCENT (g) | 4.5% 2.4% | 53.9% 63.2% |
|TERMINAL (d) | 1/29 (3%) 0/31 (0%) | 18/34 (53%) 22/36 (61%) |
|FIRST INCIDENCE | 710 606 | 649 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.507N | P=0.322 |
|POLY 3 | P=0.527N | P=0.237 |
|POLY 1.5 | P=0.517N | P=0.232 |
|POLY 6 | P=0.536N | P=0.244 |
|LOGISTIC REGRESSION| P=0.491N | P=0.235 |
|COCH-ARM / FISHERS | P=0.500N | P=0.211 |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 26/50 (52%) 30/50 (60%) |
|POLY-3 RATE (b) | 2/44.52 1/42.07 | 26/46.40 30/47.49 |
|POLY-3 PERCENT (g) | 4.5% 2.4% | 56.0% 63.2% |
|TERMINAL (d) | 1/29 (3%) 0/31 (0%) | 19/34 (56%) 22/36 (61%) |
|FIRST INCIDENCE | 710 606 | 649 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.507N | P=0.389 |
|POLY 3 | P=0.527N | P=0.307 |
|POLY 1.5 | P=0.517N | P=0.301 |
|POLY 6 | P=0.536N | P=0.318 |
|LOGISTIC REGRESSION| P=0.491N | P=0.304 |
|COCH-ARM / FISHERS | P=0.500N | P=0.273 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 8/50 (16%) | 19/50 (38%) 16/50 (32%) |
|POLY-3 RATE (b) | 13/45.01 8/42.81 | 19/46.79 16/46.45 |
|POLY-3 PERCENT (g) | 28.9% 18.7% | 40.6% 34.5% |
|TERMINAL (d) | 10/29 (35%) 4/31 (13%) | 14/34 (41%) 14/36 (39%) |
|FIRST INCIDENCE | 631 606 | 557 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.161N | P=0.281N |
|POLY 3 | P=0.193N | P=0.344N |
|POLY 1.5 | P=0.182N | P=0.335N |
|POLY 6 | P=0.200N | P=0.358N |
|LOGISTIC REGRESSION| P=0.207N | P=0.316N |
|COCH-ARM / FISHERS | P=0.163N | P=0.338N |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Prostate |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) | |
|POLY-3 RATE (b) | 0/44.44 4/41.67 | |
|POLY-3 PERCENT (g) | 0.0% 9.6% | |
|TERMINAL (d) | 0/29 (0%) 3/31 (10%) | |
|FIRST INCIDENCE | --- 724 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.073 | |
|POLY 3 | P=0.054 | |
|POLY 1.5 | P=0.057 | |
|POLY 6 | P=0.052 | |
|LOGISTIC REGRESSION| P=0.057 | |
|COCH-ARM / FISHERS | P=0.059 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or |
| Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.44 2/41.64 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 0.0% 4.8% | 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 2/31 (7%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 731 (T) | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.253 | (e) |
|POLY 3 | P=0.230 | (e) |
|POLY 1.5 | P=0.233 | (e) |
|POLY 6 | P=0.228 | (e) |
|LOGISTIC REGRESSION| P=0.253 | (e) |
|COCH-ARM / FISHERS | P=0.247 | (e) |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.93 2/41.64 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 2.2% 4.8% | 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 2/31 (7%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 586 731 (T) | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.502 | (e) |
|POLY 3 | P=0.483 | (e) |
|POLY 1.5 | P=0.490 | (e) |
|POLY 6 | P=0.477 | (e) |
|LOGISTIC REGRESSION| P=0.509 | (e) |
|COCH-ARM / FISHERS | P=0.500 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | 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%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/45.06 4/42.10 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 8.9% 9.5% | 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 2/31 (7%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 586 606 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.640N | (e) |
|POLY 3 | P=0.611 | (e) |
|POLY 1.5 | P=0.623 | (e) |
|POLY 6 | P=0.599 | (e) |
|LOGISTIC REGRESSION| P=0.638 | (e) |
|COCH-ARM / FISHERS | P=0.643N | (e) |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/44.52 6/42.61 | 0/45.04 1/45.91 |
|POLY-3 PERCENT (g) | 2.3% 14.1% | 0.0% 2.2% |
|TERMINAL (d) | 0/29 (0%) 3/31 (10%) | 0/34 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 711 577 | --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.067 | P=0.511 |
|POLY 3 | P=0.049 * | P=0.500 |
|POLY 1.5 | P=0.052 | P=0.500 |
|POLY 6 | P=0.047 * | P=0.500 |
|LOGISTIC REGRESSION| P=0.058 | P=0.511 |
|COCH-ARM / FISHERS | P=0.056 | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibroma or Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 7/50 (14%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/45.39 7/42.61 | 0/45.04 1/45.91 |
|POLY-3 PERCENT (g) | 11.0% 16.4% | 0.0% 2.2% |
|TERMINAL (d) | 1/29 (3%) 4/31 (13%) | 0/34 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 603 577 | --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.371 | P=0.511 |
|POLY 3 | P=0.338 | P=0.500 |
|POLY 1.5 | P=0.355 | P=0.500 |
|POLY 6 | P=0.322 | P=0.500 |
|LOGISTIC REGRESSION| P=0.388 | P=0.511 |
|COCH-ARM / FISHERS | P=0.380 | P=0.500 |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 7/50 (14%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/45.39 7/42.61 | 0/45.04 1/45.91 |
|POLY-3 PERCENT (g) | 11.0% 16.4% | 0.0% 2.2% |
|TERMINAL (d) | 1/29 (3%) 4/31 (13%) | 0/34 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 603 577 | --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.371 | P=0.511 |
|POLY 3 | P=0.338 | P=0.500 |
|POLY 1.5 | P=0.355 | P=0.500 |
|POLY 6 | P=0.322 | P=0.500 |
|LOGISTIC REGRESSION| P=0.388 | P=0.511 |
|COCH-ARM / FISHERS | P=0.380 | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/45.31 2/41.67 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 8.8% 4.8% | 0.0% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/31 (3%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 603 724 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.364N | (e) |
|POLY 3 | P=0.384N | (e) |
|POLY 1.5 | P=0.364N | (e) |
|POLY 6 | P=0.406N | (e) |
|LOGISTIC REGRESSION| P=0.337N | (e) |
|COCH-ARM / FISHERS | P=0.339N | (e) |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/45.31 2/41.67 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 8.8% 4.8% | 0.0% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/31 (3%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 603 724 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.364N | (e) |
|POLY 3 | P=0.384N | (e) |
|POLY 1.5 | P=0.364N | (e) |
|POLY 6 | P=0.406N | (e) |
|LOGISTIC REGRESSION| P=0.337N | (e) |
|COCH-ARM / FISHERS | P=0.339N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/44.58 2/42.10 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 6.7% 4.8% | 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 0/31 (0%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 696 606 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.501N | (e) |
|POLY 3 | P=0.532N | (e) |
|POLY 1.5 | P=0.520N | (e) |
|POLY 6 | P=0.542N | (e) |
|LOGISTIC REGRESSION| P=0.516N | (e) |
|COCH-ARM / FISHERS | P=0.500N | (e) |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/44.58 2/42.10 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 6.7% 4.8% | 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 0/31 (0%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 696 606 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.501N | (e) |
|POLY 3 | P=0.532N | (e) |
|POLY 1.5 | P=0.520N | (e) |
|POLY 6 | P=0.542N | (e) |
|LOGISTIC REGRESSION| P=0.516N | (e) |
|COCH-ARM / FISHERS | P=0.500N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 46/50 (92%) | |
|POLY-3 RATE (b) | 45/49.43 46/48.92 | |
|POLY-3 PERCENT (g) | 91.0% 94.0% | |
|TERMINAL (d) | 27/29 (93%) 31/31 (100%) | |
|FIRST INCIDENCE | 508 429 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.526 | |
|POLY 3 | P=0.424 | |
|POLY 1.5 | P=0.460 | |
|POLY 6 | P=0.368 | |
|LOGISTIC REGRESSION| P=0.477 | |
|COCH-ARM / FISHERS | P=0.500 | |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 8/50 (16%) | 5/50 (10%) 6/50 (12%) |
|POLY-3 RATE (b) | 4/44.44 8/41.64 | 5/45.15 6/46.16 |
|POLY-3 PERCENT (g) | 9.0% 19.2% | 11.1% 13.0% |
|TERMINAL (d) | 4/29 (14%) 8/31 (26%) | 4/34 (12%) 5/36 (14%) |
|FIRST INCIDENCE | 731 (T) 731 (T) | 708 670 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.203 | P=0.537 |
|POLY 3 | P=0.147 | P=0.514 |
|POLY 1.5 | P=0.159 | P=0.511 |
|POLY 6 | P=0.136 | P=0.518 |
|LOGISTIC REGRESSION| P=0.203 | P=0.519 |
|COCH-ARM / FISHERS | P=0.178 | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) | 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.53 2/42.07 | 3/45.09 0/45.91 |
|POLY-3 PERCENT (g) | 2.3% 4.8% | 6.7% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/31 (3%) | 2/34 (6%) 0/36 (0%) |
|FIRST INCIDENCE | 709 606 | 723 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.486 | P=0.115N |
|POLY 3 | P=0.487 | P=0.114N |
|POLY 1.5 | P=0.492 | P=0.115N |
|POLY 6 | P=0.483 | P=0.113N |
|LOGISTIC REGRESSION| P=0.510 | P=0.113N |
|COCH-ARM / FISHERS | P=0.500 | P=0.121N |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 10/50 (20%) | 8/50 (16%) 6/50 (12%) |
|POLY-3 RATE (b) | 5/44.53 10/42.07 | 8/45.20 6/46.16 |
|POLY-3 PERCENT (g) | 11.2% 23.8% | 17.7% 13.0% |
|TERMINAL (d) | 4/29 (14%) 9/31 (29%) | 6/34 (18%) 5/36 (14%) |
|FIRST INCIDENCE | 709 606 | 708 670 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.149 | P=0.349N |
|POLY 3 | P=0.104 | P=0.369N |
|POLY 1.5 | P=0.114 | P=0.373N |
|POLY 6 | P=0.095 | P=0.364N |
|LOGISTIC REGRESSION| P=0.089 | P=0.363N |
|COCH-ARM / FISHERS | P=0.131 | P=0.387N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.53 2/41.73 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 2.3% 4.8% | 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/31 (3%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 709 707 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.484 | (e) |
|POLY 3 | P=0.485 | (e) |
|POLY 1.5 | P=0.491 | (e) |
|POLY 6 | P=0.480 | (e) |
|LOGISTIC REGRESSION| P=0.470 | (e) |
|COCH-ARM / FISHERS | P=0.500 | (e) |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/44.89 2/41.73 | 0/45.04 1/46.09 |
|POLY-3 PERCENT (g) | 4.5% 4.8% | 0.0% 2.2% |
|TERMINAL (d) | 0/29 (0%) 1/31 (3%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 631 707 | --- 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.666 | P=0.505 |
|POLY 3 | P=0.675 | P=0.500 |
|POLY 1.5 | P=0.682 | P=0.500 |
|POLY 6 | P=0.668 | P=0.500 |
|LOGISTIC REGRESSION| P=0.688 | P=0.492 |
|COCH-ARM / FISHERS | P=0.691N | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | | 7/50 (14%) 7/50 (14%) |
|POLY-3 RATE (b) | | 7/45.35 7/46.79 |
|POLY-3 PERCENT (g) | | 15.4% 15.0% |
|TERMINAL (d) | | 6/34 (18%) 3/36 (8%) |
|FIRST INCIDENCE | | 649 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.575N |
|POLY 3 | | P=0.587N |
|POLY 1.5 | | P=0.595N |
|POLY 6 | | P=0.576N |
|LOGISTIC REGRESSION| | P=0.606N |
|COCH-ARM / FISHERS | | P=0.613N |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 18/50 (36%) | 9/50 (18%) 12/50 (24%) |
|POLY-3 RATE (b) | 22/47.65 18/46.02 | 9/47.27 12/48.23 |
|POLY-3 PERCENT (g) | 46.2% 39.1% | 19.0% 24.9% |
|TERMINAL (d) | 10/29 (35%) 9/31 (29%) | 2/34 (6%) 6/36 (17%) |
|FIRST INCIDENCE | 524 429 | 203 523 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.322N | P=0.358 |
|POLY 3 | P=0.315N | P=0.329 |
|POLY 1.5 | P=0.296N | P=0.322 |
|POLY 6 | P=0.339N | P=0.337 |
|LOGISTIC REGRESSION| P=0.181N | P=0.244 |
|COCH-ARM / FISHERS | P=0.270N | P=0.312 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/44.60 2/41.64 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 6.7% 4.8% | 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 2/31 (7%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 690 731 (T) | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491N | (e) |
|POLY 3 | P=0.538N | (e) |
|POLY 1.5 | P=0.523N | (e) |
|POLY 6 | P=0.553N | (e) |
|LOGISTIC REGRESSION| P=0.541N | (e) |
|COCH-ARM / FISHERS | P=0.500N | (e) |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/44.60 2/41.64 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 6.7% 4.8% | 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 2/31 (7%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 690 731 (T) | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491N | (e) |
|POLY 3 | P=0.538N | (e) |
|POLY 1.5 | P=0.523N | (e) |
|POLY 6 | P=0.553N | (e) |
|LOGISTIC REGRESSION| P=0.541N | (e) |
|COCH-ARM / FISHERS | P=0.500N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 49/50 (98%) | 39/50 (78%) 39/50 (78%) |
|POLY-3 RATE (b) | 50/50.00 49/49.71 | 39/47.85 39/47.49 |
|POLY-3 PERCENT (g) | 100.0% 98.6% | 81.5% 82.1% |
|TERMINAL (d) | 29/29 (100%) 31/31 (100%) | 28/34 (82%) 31/36 (86%) |
|FIRST INCIDENCE | 508 429 | 557 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.484N | P=0.430N |
|POLY 3 | P=0.656N | P=0.578 |
|POLY 1.5 | P=0.573N | P=0.601N |
|POLY 6 | P=0.833N | P=0.535 |
|LOGISTIC REGRESSION| P=0.534N | P=0.538N |
|COCH-ARM / FISHERS | P=0.500N | P=0.595N |
|=================================================================================================================================|
Date: 06/18/01 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 VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 27/50 (54%) | 21/50 (42%) 18/50 (36%) |
|POLY-3 RATE (b) | 30/48.60 27/46.76 | 21/48.39 18/48.80 |
|POLY-3 PERCENT (g) | 61.7% 57.8% | 43.4% 36.9% |
|TERMINAL (d) | 14/29 (48%) 15/31 (48%) | 10/34 (29%) 10/36 (28%) |
|FIRST INCIDENCE | 524 429 | 203 523 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.403N | P=0.315N |
|POLY 3 | P=0.427N | P=0.327N |
|POLY 1.5 | P=0.390N | P=0.332N |
|POLY 6 | P=0.475N | P=0.324N |
|LOGISTIC REGRESSION| P=0.282N | P=0.381N |
|COCH-ARM / FISHERS | P=0.343N | P=0.341N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) | 45/50 (90%) 47/50 (94%) |
|POLY-3 RATE (b) | 50/50.00 50/50.00 | 45/50.00 47/50.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% | 90.0% 94.0% |
|TERMINAL (d) | 29/29 (100%) 31/31 (100%) | 29/34 (85%) 33/36 (92%) |
|FIRST INCIDENCE | 508 429 | 203 523 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.557N |
|POLY 3 | (e) | P=0.357 |
|POLY 1.5 | (e) | P=0.357 |
|POLY 6 | (e) | P=0.357 |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | (e) | P=0.357 |
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(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).