TDMS Study 88007-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus SODIUM NITRITE DATE: 05/13/99
EXPERIMENT: 88007 TEST: 06 TIME: 09:40:55
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-55384 ROUTE: DOSED WATER NTP C#: C88007
PATHOLOGIST: TOFT, JOHN CAS: 7632-00-0
------------------------------------------------------------------------------------------------------------------------------------
2 YEAR CHRONIC MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus SODIUM NITRITE DATE: 05/13/99
EXPERIMENT: 88007 TEST: 06 TIME: 09:40:55
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55384 ROUTE: DOSED WATER NTP C#: C88007
PATHOLOGIST: TOFT, JOHN CAS: 7632-00-0
Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Medulla
Bone Marrow
Brain
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pituitary Gland
Spleen
Testes
Thymus
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus SODIUM NITRITE DATE: 05/13/99
EXPERIMENT: 88007 TEST: 06 TIME: 09:40:55
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55384 ROUTE: DOSED WATER NTP C#: C88007
PATHOLOGIST: TOFT, JOHN CAS: 7632-00-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF SODIUM NITRITE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Intestine Small: Jejunum Carcinoma
Intestine Small: Site Unspecified Carcinoma
Liver Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
All Organs Malignant Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Skin Fibrosarcoma
Schwannoma Malignant
Stomach, Forestomach Squamous Cell Carcinoma
Squamous Cell Carcinoma or Papilloma Squamous
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.3% 0.0% 0.0% 0.0% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 1/39 (3%) 0/45 (0%) 0/41 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 661 --- --- --- |--- 605 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.117N P=0.222N P=0.232N P=0.245N |P=0.568N P=0.517 (e) (e) |
|POLY 3 | P=0.114N P=0.234N P=0.239N P=0.245N |P=0.564N P=0.502 (e) (e) |
|POLY 1.5 | P=0.114N P=0.236N P=0.240N P=0.242N |P=0.565N P=0.501 (e) (e) |
|POLY 6 | P=0.114N P=0.231N P=0.239N P=0.248N |P=0.564N P=0.499 (e) (e) |
|LOGISTIC REGRESSION| P=0.111N P=0.242N P=0.254N P=0.230N |P=0.523N P=0.441 (e) (e) |
|COCH-ARM / FISHERS | P=0.116N P=0.247N P=0.253N P=0.247N |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 4/50 (8%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 8.5% 6.2% 8.4% 2.2% |0.0% 2.2% 0.0% 4.3% |
|TERMINAL (d) | 2/39 (5%) 2/45 (4%) 4/42 (10%) 1/39 (3%) |0/40 (0%) 1/34 (3%) 0/37 (0%) 2/41 (5%) |
|FIRST INCIDENCE | 661 612 727 (T) 727 (T) |--- 728 (T) --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.171N P=0.446N P=0.606N P=0.188N |P=0.157 P=0.468 (e) P=0.244 |
|POLY 3 | P=0.173N P=0.488N P=0.637N P=0.190N |P=0.142 P=0.500 (e) P=0.241 |
|POLY 1.5 | P=0.167N P=0.494N P=0.639N P=0.186N |P=0.141 P=0.500 (e) P=0.239 |
|POLY 6 | P=0.181N P=0.478N P=0.637N P=0.195N |P=0.145 P=0.496 (e) P=0.244 |
|LOGISTIC REGRESSION| P=0.159N P=0.510N P=0.635N P=0.185N |(e) P=0.468 (e) P=0.244 |
|COCH-ARM / FISHERS | P=0.157N P=0.500N P=0.643N P=0.181N |P=0.140 P=0.500 (e) P=0.247 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.2% 0.0% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 2/42 (5%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 1/37 (3%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- 727 (T) --- |--- --- 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.588 (e) P=0.255 (e) |P=0.698 (e) P=0.484 (e) |
|POLY 3 | P=0.574 (e) P=0.241 (e) |P=0.700 (e) P=0.504 (e) |
|POLY 1.5 | P=0.582 (e) P=0.240 (e) |P=0.696 (e) P=0.503 (e) |
|POLY 6 | P=0.564 (e) P=0.242 (e) |P=0.708 (e) P=0.506 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.255 (e) |(e) (e) P=0.484 (e) |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 5/50 (10%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 8.5% 6.2% 10.5% 2.2% |0.0% 2.2% 2.1% 4.3% |
|TERMINAL (d) | 2/39 (5%) 2/45 (4%) 5/42 (12%) 1/39 (3%) |0/40 (0%) 1/34 (3%) 1/37 (3%) 2/41 (5%) |
|FIRST INCIDENCE | 661 612 727 (T) 727 (T) |--- 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.194N P=0.446N P=0.540 P=0.188N |P=0.173 P=0.468 P=0.484 P=0.244 |
|POLY 3 | P=0.198N P=0.488N P=0.506 P=0.190N |P=0.158 P=0.500 P=0.504 P=0.241 |
|POLY 1.5 | P=0.190N P=0.494N P=0.504 P=0.186N |P=0.156 P=0.500 P=0.503 P=0.239 |
|POLY 6 | P=0.207N P=0.478N P=0.507 P=0.195N |P=0.162 P=0.496 P=0.506 P=0.244 |
|LOGISTIC REGRESSION| P=0.183N P=0.510N P=0.512 P=0.185N |(e) P=0.468 P=0.484 P=0.244 |
|COCH-ARM / FISHERS | P=0.178N P=0.500N P=0.500 P=0.181N |P=0.153 P=0.500 P=0.500 P=0.247 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Duodenum |
| Polyp Adenomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.3% 8.4% 6.3% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/39 (5%) 4/45 (9%) 3/42 (7%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.141N P=0.405 P=0.534 P=0.238N |(e) (e) (e) (e) |
|POLY 3 | P=0.146N P=0.347 P=0.508 P=0.244N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.142N P=0.342 P=0.505 P=0.241N |(e) (e) (e) (e) |
|POLY 6 | P=0.150N P=0.355 P=0.511 P=0.246N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.141N P=0.405 P=0.534 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.137N P=0.339 P=0.500 P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 10.6% 2.1% 2.1% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/39 (10%) 1/45 (2%) 1/42 (2%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 643 727 (T) 727 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.016N* P=0.081N P=0.092N P=0.036N* |(e) (e) (e) (e) |
|POLY 3 | P=0.016N* P=0.098N P=0.099N P=0.034N* |(e) (e) (e) (e) |
|POLY 1.5 | P=0.015N* P=0.100N P=0.100N P=0.033N* |(e) (e) (e) (e) |
|POLY 6 | P=0.016N* P=0.095N P=0.098N P=0.035N* |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.016N* P=0.102N P=0.101N P=0.035N* |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.016N* P=0.102N P=0.102N P=0.028N* |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 10.6% 4.2% 2.1% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/39 (10%) 2/45 (4%) 1/42 (2%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 643 727 (T) 727 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.014N* P=0.173N P=0.092N P=0.036N* |(e) (e) (e) (e) |
|POLY 3 | P=0.014N* P=0.211N P=0.099N P=0.034N* |(e) (e) (e) (e) |
|POLY 1.5 | P=0.014N* P=0.214N P=0.100N P=0.033N* |(e) (e) (e) (e) |
|POLY 6 | P=0.015N* P=0.206N P=0.098N P=0.035N* |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.015N* P=0.211N P=0.101N P=0.035N* |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.014N* P=0.218N P=0.102N P=0.028N* |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Polyp Adenomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.3% 8.4% 6.3% 2.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/39 (5%) 4/45 (9%) 3/42 (7%) 1/39 (3%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) 727 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.305N P=0.405 P=0.534 P=0.500N |(e) (e) (e) (e) |
|POLY 3 | P=0.307N P=0.347 P=0.508 P=0.510N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.301N P=0.342 P=0.505 P=0.506N |(e) (e) (e) (e) |
|POLY 6 | P=0.313N P=0.355 P=0.511 P=0.514N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.305N P=0.405 P=0.534 P=0.500N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.292N P=0.339 P=0.500 P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.4% 4.2% 4.2% 0.0% |0.0% 0.0% 6.4% 0.0% |
|TERMINAL (d) | 1/39 (3%) 2/45 (4%) 2/42 (5%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 2/37 (5%) 0/41 (0%) |
|FIRST INCIDENCE | 652 727 (T) 727 (T) --- |--- --- 716 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.092N P=0.457N P=0.480N P=0.131N |P=0.555 (e) P=0.114 (e) |
|POLY 3 | P=0.093N P=0.495N P=0.497N P=0.126N |P=0.550 (e) P=0.123 (e) |
|POLY 1.5 | P=0.090N P=0.497N P=0.497N P=0.123N |P=0.543 (e) P=0.121 (e) |
|POLY 6 | P=0.096N P=0.490N P=0.497N P=0.129N |P=0.562 (e) P=0.125 (e) |
|LOGISTIC REGRESSION| P=0.086N P=0.505N P=0.511N P=0.111N |P=0.556 (e) P=0.125 (e) |
|COCH-ARM / FISHERS | P=0.086N P=0.500N P=0.500N P=0.121N |P=0.539 (e) P=0.121 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.4% 6.3% 4.2% 0.0% |0.0% 2.2% 6.4% 0.0% |
|TERMINAL (d) | 1/39 (3%) 3/45 (7%) 2/42 (5%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 2/37 (5%) 0/41 (0%) |
|FIRST INCIDENCE | 652 727 (T) 727 (T) --- |--- 664 716 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.077N P=0.613N P=0.480N P=0.131N |P=0.609N P=0.500 P=0.114 (e) |
|POLY 3 | P=0.078N P=0.657N P=0.497N P=0.126N |P=0.627N P=0.501 P=0.123 (e) |
|POLY 1.5 | P=0.075N P=0.659N P=0.497N P=0.123N |P=0.631N P=0.501 P=0.121 (e) |
|POLY 6 | P=0.081N P=0.652N P=0.497N P=0.129N |P=0.618N P=0.498 P=0.125 (e) |
|LOGISTIC REGRESSION| P=0.073N P=0.661 P=0.511N P=0.111N |P=0.632N P=0.483 P=0.125 (e) |
|COCH-ARM / FISHERS | P=0.072N P=0.661N P=0.500N P=0.121N |P=0.634 P=0.500 P=0.121 (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.3% 4.2% 2.1% 4.3% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 1/39 (3%) 2/45 (4%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 1/37 (3%) 0/41 (0%) |
|FIRST INCIDENCE | 705 727 (T) 664 549 |--- --- 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.595N P=0.646N P=0.481N P=0.683 |P=0.698 (e) P=0.484 (e) |
|POLY 3 | P=0.582N P=0.687N P=0.493N P=0.688 |P=0.700 (e) P=0.504 (e) |
|POLY 1.5 | P=0.580N P=0.690N P=0.496N P=0.690 |P=0.696 (e) P=0.503 (e) |
|POLY 6 | P=0.583N P=0.681N P=0.490N P=0.687 |P=0.708 (e) P=0.506 (e) |
|LOGISTIC REGRESSION| P=0.538N P=0.681N P=0.516N P=0.657N |(e) (e) P=0.484 (e) |
|COCH-ARM / FISHERS | P=0.577N P=0.691N P=0.500N P=0.691N |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 10.6% 2.1% 4.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/39 (8%) 1/45 (2%) 2/42 (5%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 617 727 (T) 727 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.027N* P=0.085N P=0.199N P=0.039N* |(e) (e) (e) (e) |
|POLY 3 | P=0.027N* P=0.099N P=0.214N P=0.034N* |(e) (e) (e) (e) |
|POLY 1.5 | P=0.026N* P=0.101N P=0.215N P=0.033N* |(e) (e) (e) (e) |
|POLY 6 | P=0.028N* P=0.097N P=0.214N P=0.036N* |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.025N* P=0.105N P=0.220N P=0.032N* |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.025N* P=0.102N P=0.218N P=0.028N* |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 17/50 (34%) 13/50 (26%) 18/50 (36%) |9/50 (18%) 7/50 (14%) 3/50 (6%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 40.1% 35.4% 27.3% 38.5% |19.5% 15.2% 6.4% 12.9% |
|TERMINAL (d) | 16/39 (41%) 16/45 (36%) 13/42 (31%) 14/39 (36%) |8/40 (20%) 5/34 (15%) 3/37 (8%) 6/41 (15%) |
|FIRST INCIDENCE | 643 637 727 (T) 472 |586 667 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.514N P=0.247N P=0.095N P=0.513N |P=0.171N P=0.506N P=0.079N P=0.271N |
|POLY 3 | P=0.473N P=0.395N P=0.134N P=0.521N |P=0.197N P=0.394N P=0.057N P=0.283N |
|POLY 1.5 | P=0.463N P=0.406N P=0.136N P=0.513N |P=0.201N P=0.392N P=0.058N P=0.287N |
|POLY 6 | P=0.486N P=0.377N P=0.135N P=0.528N |P=0.190N P=0.406N P=0.055N P=0.276N |
|LOGISTIC REGRESSION| P=0.504N P=0.374N P=0.118N P=0.534N |P=0.184N P=0.394N P=0.056N P=0.270N |
|COCH-ARM / FISHERS | P=0.450N P=0.418N P=0.142N P=0.500N |P=0.203N P=0.393N P=0.061N P=0.288N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 10/50 (20%) 6/50 (12%) 9/50 (18%) |2/50 (4%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 19.1% 20.6% 12.5% 19.3% |4.4% 4.4% 8.5% 2.2% |
|TERMINAL (d) | 8/39 (21%) 8/45 (18%) 5/42 (12%) 5/39 (13%) |2/40 (5%) 1/34 (3%) 3/37 (8%) 1/41 (2%) |
|FIRST INCIDENCE | 617 601 596 583 |728 (T) 673 691 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.519N P=0.585N P=0.245N P=0.588 |P=0.399N P=0.645 P=0.312 P=0.491N |
|POLY 3 | P=0.490N P=0.527 P=0.275N P=0.591 |P=0.422N P=0.693N P=0.349 P=0.494N |
|POLY 1.5 | P=0.485N P=0.514 P=0.280N P=0.594 |P=0.428N P=0.692N P=0.344 P=0.498N |
|POLY 6 | P=0.493N P=0.548 P=0.269N P=0.594 |P=0.411N P=0.690 P=0.354 P=0.489N |
|LOGISTIC REGRESSION| P=0.458N P=0.499 P=0.287N P=0.602N |P=0.417N P=0.692 P=0.351 P=0.491N |
|COCH-ARM / FISHERS | P=0.475N P=0.500 P=0.288N P=0.602N |P=0.431N P=0.691N P=0.339 P=0.500N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 11/50 (22%) 7/50 (14%) 9/50 (18%) |2/50 (4%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 25.4% 22.7% 14.6% 19.3% |4.4% 4.4% 8.5% 2.2% |
|TERMINAL (d) | 10/39 (26%) 9/45 (20%) 6/42 (14%) 5/39 (13%) |2/40 (5%) 1/34 (3%) 3/37 (8%) 1/41 (2%) |
|FIRST INCIDENCE | 617 601 596 583 |728 (T) 673 691 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.267N P=0.374N P=0.124N P=0.332N |P=0.399N P=0.645 P=0.312 P=0.491N |
|POLY 3 | P=0.239N P=0.472N P=0.143N P=0.325N |P=0.422N P=0.693N P=0.349 P=0.494N |
|POLY 1.5 | P=0.235N P=0.486N P=0.147N P=0.321N |P=0.428N P=0.692N P=0.344 P=0.498N |
|POLY 6 | P=0.243N P=0.451N P=0.139N P=0.324N |P=0.411N P=0.690 P=0.354 P=0.489N |
|LOGISTIC REGRESSION| P=0.219N P=0.497N P=0.150N P=0.316N |P=0.417N P=0.692 P=0.351 P=0.491N |
|COCH-ARM / FISHERS | P=0.225N P=0.500N P=0.154N P=0.312N |P=0.431N P=0.691N P=0.339 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 24/50 (48%) 16/50 (32%) 25/50 (50%) |10/50 (20%) 8/50 (16%) 7/50 (14%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 50.2% 49.2% 33.3% 52.4% |21.6% 17.3% 14.9% 15.1% |
|TERMINAL (d) | 20/39 (51%) 21/45 (47%) 15/42 (36%) 18/39 (46%) |9/40 (23%) 6/34 (18%) 6/37 (16%) 7/41 (17%) |
|FIRST INCIDENCE | 617 601 596 472 |586 667 691 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.447 P=0.354N P=0.048N* P=0.482 |P=0.212N P=0.523N P=0.349N P=0.278N |
|POLY 3 | P=0.516 P=0.539N P=0.068N P=0.499 |P=0.250N P=0.399N P=0.285N P=0.292N |
|POLY 1.5 | P=0.521 P=0.558N P=0.070N P=0.498 |P=0.256N P=0.396N P=0.290N P=0.296N |
|POLY 6 | P=0.513 P=0.508N P=0.067N P=0.508 |P=0.239N P=0.412N P=0.280N P=0.284N |
|LOGISTIC REGRESSION| P=0.506 P=0.560N P=0.066N P=0.479 |P=0.229N P=0.402N P=0.277N P=0.276N |
|COCH-ARM / FISHERS | P=0.529 P=0.579N P=0.076N P=0.500 |P=0.257N P=0.398N P=0.298N P=0.298N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 25/50 (50%) 17/50 (34%) 25/50 (50%) |10/50 (20%) 8/50 (16%) 7/50 (14%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 54.3% 51.2% 35.4% 52.4% |21.6% 17.3% 14.9% 15.1% |
|TERMINAL (d) | 21/39 (54%) 22/45 (49%) 16/42 (38%) 18/39 (46%) |9/40 (23%) 6/34 (18%) 6/37 (16%) 7/41 (17%) |
|FIRST INCIDENCE | 617 601 596 472 |586 667 691 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.484N P=0.279N P=0.033N* P=0.520N |P=0.212N P=0.523N P=0.349N P=0.278N |
|POLY 3 | P=0.410N P=0.460N P=0.046N* P=0.506N |P=0.250N P=0.399N P=0.285N P=0.292N |
|POLY 1.5 | P=0.404N P=0.479N P=0.048N* P=0.505N |P=0.256N P=0.396N P=0.290N P=0.296N |
|POLY 6 | P=0.415N P=0.430N P=0.046N* P=0.501N |P=0.239N P=0.412N P=0.280N P=0.284N |
|LOGISTIC REGRESSION| P=0.422N P=0.478N P=0.044N* P=0.524N |P=0.229N P=0.402N P=0.277N P=0.276N |
|COCH-ARM / FISHERS | P=0.396N P=0.500N P=0.053N P=0.500N |P=0.257N P=0.398N P=0.298N P=0.298N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 5/50 (10%) 9/50 (18%) 10/50 (20%) |1/50 (2%) 4/50 (8%) 3/50 (6%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 21.2% 10.4% 18.9% 22.0% |2.2% 8.7% 6.4% 10.8% |
|TERMINAL (d) | 9/39 (23%) 4/45 (9%) 8/42 (19%) 10/39 (26%) |1/40 (3%) 2/34 (6%) 3/37 (8%) 5/41 (12%) |
|FIRST INCIDENCE | 617 644 707 727 (T) |728 (T) 659 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.333 P=0.087N P=0.433N P=0.596 |P=0.142 P=0.154 P=0.278 P=0.109 |
|POLY 3 | P=0.335 P=0.121N P=0.490N P=0.562 |P=0.118 P=0.181 P=0.313 P=0.105 |
|POLY 1.5 | P=0.352 P=0.126N P=0.494N P=0.576 |P=0.115 P=0.181 P=0.310 P=0.103 |
|POLY 6 | P=0.315 P=0.114N P=0.487N P=0.546 |P=0.123 P=0.178 P=0.316 P=0.108 |
|LOGISTIC REGRESSION| P=0.327 P=0.127N P=0.477N P=0.558 |P=0.122 P=0.179 P=0.278 P=0.109 |
|COCH-ARM / FISHERS | P=0.375 P=0.131N P=0.500N P=0.598N |P=0.113 P=0.181 P=0.309 P=0.102 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 3/50 (6%) 7/50 (14%) |0/50 (0%) 3/50 (6%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 8.4% 2.1% 6.3% 15.1% |0.0% 6.6% 4.3% 2.2% |
|TERMINAL (d) | 3/39 (8%) 1/45 (2%) 3/42 (7%) 5/39 (13%) |0/40 (0%) 3/34 (9%) 2/37 (5%) 1/41 (2%) |
|FIRST INCIDENCE | 526 727 (T) 727 (T) 502 |--- 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.070 P=0.149N P=0.464N P=0.262 |P=0.580 P=0.094 P=0.221 P=0.505 |
|POLY 3 | P=0.074 P=0.177N P=0.498N P=0.249 |P=0.566 P=0.118 P=0.242 P=0.503 |
|POLY 1.5 | P=0.076 P=0.178N P=0.499N P=0.254 |P=0.560 P=0.119 P=0.240 P=0.501 |
|POLY 6 | P=0.071 P=0.173N P=0.497N P=0.246 |P=0.575 P=0.115 P=0.244 P=0.506 |
|LOGISTIC REGRESSION| P=0.098 P=0.185N P=0.525N P=0.304 |(e) P=0.094 P=0.221 P=0.505 |
|COCH-ARM / FISHERS | P=0.080 P=0.181N P=0.500N P=0.262 |P=0.556 P=0.121 P=0.247 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 6/50 (12%) 12/50 (24%) 17/50 (34%) |1/50 (2%) 6/50 (12%) 5/50 (10%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 27.2% 12.5% 25.2% 36.6% |2.2% 13.0% 10.7% 12.9% |
|TERMINAL (d) | 11/39 (28%) 5/45 (11%) 11/42 (26%) 15/39 (39%) |1/40 (3%) 4/34 (12%) 5/37 (14%) 6/41 (15%) |
|FIRST INCIDENCE | 526 644 707 502 |728 (T) 659 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.056 P=0.037N* P=0.422N P=0.253 |P=0.136 P=0.044 * P=0.086 P=0.062 |
|POLY 3 | P=0.057 P=0.059N P=0.503N P=0.223 |P=0.110 P=0.057 P=0.106 P=0.059 |
|POLY 1.5 | P=0.063 P=0.061N P=0.501N P=0.236 |P=0.107 P=0.057 P=0.105 P=0.057 |
|POLY 6 | P=0.051 P=0.055N P=0.506N P=0.211 |P=0.116 P=0.055 P=0.108 P=0.061 |
|LOGISTIC REGRESSION| P=0.066 P=0.065N P=0.490N P=0.248 |P=0.120 P=0.058 P=0.086 P=0.062 |
|COCH-ARM / FISHERS | P=0.073 P=0.062N P=0.500N P=0.257 |P=0.105 P=0.056 P=0.102 P=0.056 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |0/47 (0%) 2/49 (4%) 1/50 (2%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| |0.0% 4.5% 2.1% 6.6% |
|TERMINAL (d) | |0/37 (0%) 2/33 (6%) 1/37 (3%) 3/40 (8%) |
|FIRST INCIDENCE | |--- 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.130 P=0.213 P=0.500 P=0.135 |
|POLY 3 | |P=0.113 P=0.247 P=0.518 P=0.130 |
|POLY 1.5 | |P=0.111 P=0.248 P=0.516 P=0.128 |
|POLY 6 | |P=0.117 P=0.243 P=0.520 P=0.133 |
|LOGISTIC REGRESSION| |(e) P=0.213 P=0.500 P=0.135 |
|COCH-ARM / FISHERS | |P=0.108 P=0.258 P=0.515 P=0.129 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |0/47 (0%) 2/49 (4%) 1/50 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| |0.0% 4.5% 2.1% 2.2% |
|TERMINAL (d) | |0/37 (0%) 2/33 (6%) 1/37 (3%) 1/40 (3%) |
|FIRST INCIDENCE | |--- 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.535 P=0.213 P=0.500 P=0.516 |
|POLY 3 | |P=0.520 P=0.247 P=0.518 P=0.512 |
|POLY 1.5 | |P=0.515 P=0.248 P=0.516 P=0.510 |
|POLY 6 | |P=0.528 P=0.243 P=0.520 P=0.516 |
|LOGISTIC REGRESSION| |(e) P=0.213 P=0.500 P=0.516 |
|COCH-ARM / FISHERS | |P=0.511 P=0.258 P=0.515 P=0.510 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/47 (0%) 0/47 (0%) |1/48 (2%) 3/47 (6%) 0/43 (0%) 1/48 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.3% 6.9% 0.0% 2.2% |
|TERMINAL (d) | 0/38 (0%) 0/44 (0%) 0/40 (0%) 0/37 (0%) |1/38 (3%) 2/32 (6%) 0/33 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- |728 (T) 643 --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.384N P=0.273 P=0.528N P=0.750N |
|POLY 3 | (e) (e) (e) (e) |P=0.401N P=0.305 P=0.515N P=0.754N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.406N P=0.303 P=0.518N P=0.757N |
|POLY 6 | (e) (e) (e) (e) |P=0.396N P=0.301 P=0.513N P=0.749N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.408N P=0.299 (e) P=0.750N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.412N P=0.301 P=0.527N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 5/50 (10%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.2% 10.7% 2.1% 6.4% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 1/34 (3%) 0/37 (0%) 2/41 (5%) |
|FIRST INCIDENCE | --- --- --- --- |586 651 477 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.491 P=0.103 P=0.753N P=0.317 |
|POLY 3 | (e) (e) (e) (e) |P=0.462 P=0.103 P=0.755N P=0.308 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.459 P=0.103 P=0.757N P=0.306 |
|POLY 6 | (e) (e) (e) (e) |P=0.468 P=0.101 P=0.753N P=0.312 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.474 P=0.081 P=0.741 P=0.303 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.456 P=0.102 P=0.753N P=0.309 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 5/50 (10%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 10.7% 2.1% 4.3% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 1/34 (3%) 0/37 (0%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- --- --- |--- 651 477 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.534 P=0.032 * P=0.504 P=0.248 |
|POLY 3 | (e) (e) (e) (e) |P=0.514 P=0.032 * P=0.507 P=0.241 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.507 P=0.032 * P=0.505 P=0.239 |
|POLY 6 | (e) (e) (e) (e) |P=0.524 P=0.032 * P=0.510 P=0.245 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.517 P=0.029 * P=0.405 P=0.241 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.500 P=0.028 * P=0.500 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 5/50 (10%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.2% 10.7% 2.1% 4.3% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 1/34 (3%) 0/37 (0%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- --- --- |586 651 477 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.491N P=0.103 P=0.753N P=0.508 |
|POLY 3 | (e) (e) (e) (e) |P=0.517N P=0.103 P=0.755N P=0.503 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.520N P=0.103 P=0.757N P=0.501 |
|POLY 6 | (e) (e) (e) (e) |P=0.512N P=0.101 P=0.753N P=0.506 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.498N P=0.081 P=0.741 P=0.501 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.523N P=0.102 P=0.753N P=0.500 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Schwannoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.2% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 520 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.051 (e) (e) P=0.240 |
|POLY 3 | (e) (e) (e) (e) |P=0.047 * (e) (e) P=0.244 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.241 |
|POLY 6 | (e) (e) (e) (e) |P=0.048 * (e) (e) P=0.249 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.060 (e) (e) P=0.249 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/49 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.4% 0.0% 4.2% 0.0% |0.0% 2.2% 4.3% 0.0% |
|TERMINAL (d) | 2/39 (5%) 0/45 (0%) 1/42 (2%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 2/37 (5%) 0/41 (0%) |
|FIRST INCIDENCE | 661 --- 707 --- |--- 605 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.131N P=0.105N P=0.472N P=0.126N |P=0.602N P=0.517 P=0.221 (e) |
|POLY 3 | P=0.131N P=0.116N P=0.494N P=0.125N |P=0.610N P=0.503 P=0.244 (e) |
|POLY 1.5 | P=0.128N P=0.118N P=0.496N P=0.123N |P=0.612N P=0.504 P=0.243 (e) |
|POLY 6 | P=0.135N P=0.114N P=0.492N P=0.128N |P=0.605N P=0.500 P=0.245 (e) |
|LOGISTIC REGRESSION| P=0.125N P=0.122N P=0.501N P=0.121N |P=0.607N P=0.459 P=0.221 (e) |
|COCH-ARM / FISHERS | P=0.125N P=0.121N P=0.500N P=0.121N |P=0.612N P=0.505 P=0.253 (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.3% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 2/41 (5%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.055 (e) (e) P=0.244 |
|POLY 3 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.241 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.239 |
|POLY 6 | (e) (e) (e) (e) |P=0.047 * (e) (e) P=0.244 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.244 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 2.1% 2.1% 0.0% 2.2% |2.2% 0.0% 2.1% 10.7% |
|TERMINAL (d) | 1/39 (3%) 1/45 (2%) 0/42 (0%) 1/39 (3%) |1/40 (3%) 0/34 (0%) 1/37 (3%) 4/41 (10%) |
|FIRST INCIDENCE | 727 (T) 727 (T) --- 727 (T) |728 (T) --- 728 (T) 708 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.629N P=0.730N P=0.485N P=0.762 |P=0.016 * P=0.532N P=0.744 P=0.111 |
|POLY 3 | P=0.616N P=0.756N P=0.497N P=0.754 |P=0.011 * P=0.500N P=0.756N P=0.106 |
|POLY 1.5 | P=0.616N P=0.758N P=0.498N P=0.756 |P=0.011 * P=0.500N P=0.758N P=0.104 |
|POLY 6 | P=0.617N P=0.752N P=0.495N P=0.752 |P=0.012 * P=0.504N P=0.754N P=0.109 |
|LOGISTIC REGRESSION| P=0.629N P=0.730N (e) P=0.762 |P=0.014 * (e) P=0.744 P=0.112 |
|COCH-ARM / FISHERS | P=0.616N P=0.753N P=0.500N P=0.753N |P=0.011 * P=0.500N P=0.753N P=0.102 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 16
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.1% 2.1% 0.0% 2.2% |2.2% 0.0% 2.1% 6.4% |
|TERMINAL (d) | 1/39 (3%) 1/45 (2%) 0/42 (0%) 1/39 (3%) |1/40 (3%) 0/34 (0%) 1/37 (3%) 2/41 (5%) |
|FIRST INCIDENCE | 727 (T) 727 (T) --- 727 (T) |728 (T) --- 728 (T) 708 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.629N P=0.730N P=0.485N P=0.762 |P=0.114 P=0.532N P=0.744 P=0.316 |
|POLY 3 | P=0.616N P=0.756N P=0.497N P=0.754 |P=0.099 P=0.500N P=0.756N P=0.312 |
|POLY 1.5 | P=0.616N P=0.758N P=0.498N P=0.756 |P=0.097 P=0.500N P=0.758N P=0.308 |
|POLY 6 | P=0.617N P=0.752N P=0.495N P=0.752 |P=0.103 P=0.504N P=0.754N P=0.318 |
|LOGISTIC REGRESSION| P=0.629N P=0.730N (e) P=0.762 |P=0.108 (e) P=0.744 P=0.317 |
|COCH-ARM / FISHERS | P=0.616N P=0.753N P=0.500N P=0.753N |P=0.097 P=0.500N P=0.753N P=0.309 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 0.0% 4.2% 0.0% 0.0% | |
|TERMINAL (d) | 0/39 (0%) 2/45 (4%) 0/42 (0%) 0/39 (0%) | |
|FIRST INCIDENCE | --- 727 (T) --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.412N P=0.270 (e) (e) | |
|POLY 3 | P=0.405N P=0.242 (e) (e) | |
|POLY 1.5 | P=0.405N P=0.240 (e) (e) | |
|POLY 6 | P=0.404N P=0.246 (e) (e) | |
|LOGISTIC REGRESSION| (e) P=0.270 (e) (e) | |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) | |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 17
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Odontoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.2% 2.1% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 2/45 (4%) 1/42 (2%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 727 (T) 727 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.471N P=0.270 P=0.515 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.469N P=0.242 P=0.503 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.466N P=0.240 P=0.502 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.471N P=0.246 P=0.505 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.270 P=0.515 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.461N P=0.247 P=0.500 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| |0.0% 6.5% 0.0% 2.1% |
|TERMINAL (d) | |0/40 (0%) 1/34 (3%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | |--- 664 --- 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.607N P=0.107 (e) P=0.518 |
|POLY 3 | |P=0.627N P=0.120 (e) P=0.504 |
|POLY 1.5 | |P=0.631N P=0.120 (e) P=0.502 |
|POLY 6 | |P=0.624N P=0.117 (e) P=0.508 |
|LOGISTIC REGRESSION| |P=0.633N P=0.120 (e) P=0.504 |
|COCH-ARM / FISHERS | |P=0.634 P=0.121 (e) P=0.500 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 18
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.4% 2.1% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 2/34 (6%) 1/37 (3%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- --- --- |--- 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.521 P=0.203 P=0.484 P=0.505 |
|POLY 3 | (e) (e) (e) (e) |P=0.508 P=0.237 P=0.504 P=0.503 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.503 P=0.238 P=0.503 P=0.501 |
|POLY 6 | (e) (e) (e) (e) |P=0.515 P=0.233 P=0.506 P=0.506 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.203 P=0.484 P=0.505 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.500 P=0.247 P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 14.9% 4.2% 6.3% 4.3% |2.2% 2.2% 6.4% 0.0% |
|TERMINAL (d) | 5/39 (13%) 2/45 (4%) 1/42 (2%) 0/39 (0%) |1/40 (3%) 0/34 (0%) 3/37 (8%) 0/41 (0%) |
|FIRST INCIDENCE | 661 727 (T) 664 549 |728 (T) 605 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091N P=0.059N P=0.142N P=0.092N |P=0.393N P=0.752 P=0.278 P=0.495N |
|POLY 3 | P=0.083N P=0.076N P=0.151N P=0.084N |P=0.402N P=0.759N P=0.313 P=0.497N |
|POLY 1.5 | P=0.082N P=0.078N P=0.154N P=0.083N |P=0.407N P=0.759N P=0.310 P=0.499N |
|POLY 6 | P=0.085N P=0.073N P=0.148N P=0.086N |P=0.393N P=0.760 P=0.316 P=0.494N |
|LOGISTIC REGRESSION| P=0.073N P=0.076N P=0.159N P=0.073N |P=0.410N P=0.748 P=0.278 (e) |
|COCH-ARM / FISHERS | P=0.080N P=0.080N P=0.159N P=0.080N |P=0.409N P=0.753N P=0.309 P=0.500N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 19
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |1/50 (2%) 3/50 (6%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 14.9% 4.2% 6.3% 4.3% |2.2% 6.5% 8.6% 2.2% |
|TERMINAL (d) | 5/39 (13%) 2/45 (4%) 1/42 (2%) 0/39 (0%) |1/40 (3%) 2/34 (6%) 4/37 (11%) 1/41 (2%) |
|FIRST INCIDENCE | 661 727 (T) 664 549 |728 (T) 605 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091N P=0.059N P=0.142N P=0.092N |P=0.494N P=0.272 P=0.156 P=0.756N |
|POLY 3 | P=0.083N P=0.076N P=0.151N P=0.084N |P=0.513N P=0.308 P=0.185 P=0.757N |
|POLY 1.5 | P=0.082N P=0.078N P=0.154N P=0.083N |P=0.519N P=0.308 P=0.183 P=0.759N |
|POLY 6 | P=0.085N P=0.073N P=0.148N P=0.086N |P=0.502N P=0.304 P=0.188 P=0.754N |
|LOGISTIC REGRESSION| P=0.073N P=0.076N P=0.159N P=0.073N |P=0.514N P=0.303 P=0.156 P=0.756N |
|COCH-ARM / FISHERS | P=0.080N P=0.080N P=0.159N P=0.080N |P=0.523N P=0.309 P=0.181 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 4/50 (8%) 1/50 (2%) |7/50 (14%) 10/50 (20%) 8/50 (16%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 2.1% 2.1% 8.4% 2.2% |14.9% 21.5% 16.7% 12.8% |
|TERMINAL (d) | 1/39 (3%) 1/45 (2%) 3/42 (7%) 0/39 (0%) |4/40 (10%) 7/34 (21%) 4/37 (11%) 4/41 (10%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 664 594 |580 650 524 673 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.508 P=0.730N P=0.203 P=0.753 |P=0.295N P=0.248 P=0.471 P=0.474N |
|POLY 3 | P=0.508 P=0.756N P=0.186 P=0.756 |P=0.331N P=0.288 P=0.515 P=0.502N |
|POLY 1.5 | P=0.515 P=0.758N P=0.183 P=0.758 |P=0.335N P=0.295 P=0.510 P=0.503N |
|POLY 6 | P=0.501 P=0.752N P=0.189 P=0.755 |P=0.322N P=0.272 P=0.518 P=0.498N |
|LOGISTIC REGRESSION| P=0.542 P=0.730N P=0.182 P=0.734N |P=0.338N P=0.290 P=0.459 P=0.504N |
|COCH-ARM / FISHERS | P=0.526 P=0.753N P=0.181 P=0.753N |P=0.334N P=0.298 P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 20
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 28/50 (56%) 26/50 (52%) 29/50 (58%) |13/50 (26%) 22/50 (44%) 14/50 (28%) 20/50 (40%) |
|POLY-3 ADJUSTED (b)| 58.1% 57.4% 54.6% 62.0% |28.1% 46.6% 29.6% 42.7% |
|TERMINAL (d) | 22/39 (56%) 25/45 (56%) 25/42 (60%) 25/39 (64%) |12/40 (30%) 15/34 (44%) 12/37 (32%) 18/41 (44%) |
|FIRST INCIDENCE | 617 612 707 472 |586 643 610 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.373 P=0.328N P=0.294N P=0.480 |P=0.299 P=0.021 * P=0.421 P=0.118 |
|POLY 3 | P=0.385 P=0.555N P=0.444N P=0.427 |P=0.208 P=0.048 * P=0.526 P=0.103 |
|POLY 1.5 | P=0.423 P=0.567N P=0.430N P=0.459 |P=0.202 P=0.047 * P=0.515 P=0.100 |
|POLY 6 | P=0.333 P=0.535N P=0.475N P=0.385 |P=0.223 P=0.048 * P=0.538 P=0.111 |
|LOGISTIC REGRESSION| P=0.382 P=0.559N P=0.372N P=0.435 |P=0.229 P=0.045 * P=0.532 P=0.116 |
|COCH-ARM / FISHERS | P=0.471 P=0.580N P=0.421N P=0.500 |P=0.203 P=0.046 * P=0.500 P=0.101 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 15/50 (30%) 20/50 (40%) 20/50 (40%) |12/50 (24%) 21/50 (42%) 19/50 (38%) 17/50 (34%) |
|POLY-3 ADJUSTED (b)| 54.9% 30.9% 40.8% 41.1% |25.2% 43.5% 38.6% 35.1% |
|TERMINAL (d) | 20/39 (51%) 13/45 (29%) 15/42 (36%) 11/39 (28%) |7/40 (18%) 11/34 (32%) 11/37 (30%) 12/41 (29%) |
|FIRST INCIDENCE | 501 601 596 502 |580 605 477 401 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.316N P=0.006N** P=0.095N P=0.170N |P=0.405 P=0.042 * P=0.104 P=0.235 |
|POLY 3 | P=0.234N P=0.013N* P=0.116N P=0.121N |P=0.320 P=0.045 * P=0.113 P=0.201 |
|POLY 1.5 | P=0.234N P=0.012N* P=0.116N P=0.120N |P=0.312 P=0.044 * P=0.107 P=0.196 |
|POLY 6 | P=0.229N P=0.012N* P=0.115N P=0.117N |P=0.329 P=0.044 * P=0.118 P=0.205 |
|LOGISTIC REGRESSION| P=0.176N P=0.014N* P=0.131N P=0.078N |P=0.270 P=0.039 * P=0.069 P=0.175 |
|COCH-ARM / FISHERS | P=0.233N P=0.013N* P=0.115N P=0.115N |P=0.299 P=0.044 * P=0.097 P=0.189 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 21
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 40/50 (80%) 35/50 (70%) 36/50 (72%) 38/50 (76%) |21/50 (42%) 33/50 (66%) 31/50 (62%) 32/50 (64%) |
|POLY-3 ADJUSTED (b)| 80.5% 71.1% 73.5% 76.8% |44.0% 67.4% 63.0% 65.6% |
|TERMINAL (d) | 30/39 (77%) 31/45 (69%) 31/42 (74%) 28/39 (72%) |16/40 (40%) 20/34 (59%) 22/37 (60%) 25/41 (61%) |
|FIRST INCIDENCE | 501 601 596 472 |580 605 477 401 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.469 P=0.063N P=0.162N P=0.461N |P=0.156 P=0.012 * P=0.037 * P=0.052 |
|POLY 3 | P=0.479N P=0.196N P=0.279N P=0.423N |P=0.054 P=0.015 * P=0.045 * P=0.024 * |
|POLY 1.5 | P=0.473N P=0.192N P=0.262N P=0.417N |P=0.050 P=0.014 * P=0.041 * P=0.023 * |
|POLY 6 | P=0.487N P=0.193N P=0.304N P=0.425N |P=0.060 P=0.017 * P=0.048 * P=0.028 * |
|LOGISTIC REGRESSION| P=0.454N P=0.181N P=0.242N P=0.370N |P=0.045 * P=0.013 * P=0.033 * P=0.023 * |
|COCH-ARM / FISHERS | P=0.467N P=0.178N P=0.241N P=0.405N |P=0.047 * P=0.013 * P=0.036 * P=0.022 * |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Poly-3 adjusted lifetime tumor incidence.
(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.
(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).