TR 341 Rat Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst NITROFURANTOIN DATE: 09/07/94
EXPERIMENT: 05051 TEST: 01 TIME: 07:13:27
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NOIES28024 ROUTE: DOSED FEED NTP C#: C55196
PATHOLOGIST: R. THOMPSON CAS: 67-20-9
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst NITROFURANTOIN DATE: 09/07/94
EXPERIMENT: 05051 TEST: 01 TIME: 07:13:27
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NOIES28024 ROUTE: DOSED FEED NTP C#: C55196
PATHOLOGIST: R. THOMPSON CAS: 67-20-9
RATS(FISCHER344)
----------------------------
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 NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Gland
Bone Marrow
Brain
Clitoral Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst NITROFURANTOIN DATE: 09/07/94
EXPERIMENT: 05051 TEST: 01 TIME: 07:13:27
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NOIES28024 ROUTE: DOSED FEED NTP C#: C55196
PATHOLOGIST: R. THOMPSON CAS: 67-20-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF NITROFURANTOIN
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Adenoma
Carcinoma
Carcinoma or Adenoma
Skin: Subcutaneous Tissue Fibroma
Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
Neurofibroma, or Fibroma
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Adenoma
Carcinoma
Mammary Gland Carcinoma
Carcinoma or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Carcinoma
Skin Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
All Organs Malignant Tumors
====================================================================================================
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 2/49 (4%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 2.3% | 0.0% 7.3% 2.8% |
|TERMINAL (d) | 0/24 (0%) 0/27 (0%) 0/26 (0%) | 0/25 (0%) 1/26 (4%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 632 | --- 728 693 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.303 (e) P=0.530 | P=0.424 P=0.244 P=0.500 |
|INCIDENTAL TUMOR | P=0.227 (e) P=0.410 | P=0.306 P=0.190 P=0.383 |
|LOGISTIC REGRESSION | P=0.285 (e) P=0.500 | P=0.385 P=0.227 P=0.497 |
|COCHRAN-ARMITAGE | P=0.283 | P=0.392 |
|FISHER EXACT | (e) P=0.500 | P=0.242 P=0.500 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 20/50 (40%) 23/50 (46%) | 2/48 (4%) 1/48 (2%) 4/50 (8%) |
|ADJUSTED (b) | 71.1% 63.3% 64.5% | 7.6% 4.0% 11.6% |
|TERMINAL (d) | 15/24 (63%) 16/27 (59%) 14/26 (54%) | 1/25 (4%) 1/25 (4%) 3/31 (10%) |
|FIRST INCIDENCE (DAYS) | 591 548 559 | 729 730 (T) 491 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.403N P=0.177N P=0.443N | P=0.297 P=0.504N P=0.413 |
|INCIDENTAL TUMOR | P=0.485N P=0.188N P=0.536N | P=0.288 P=0.556N P=0.412 |
|LOGISTIC REGRESSION | P=0.433N P=0.163N P=0.477N | P=0.236 P=0.520N P=0.353 |
|COCHRAN-ARMITAGE | P=0.535N | P=0.244 |
|FISHER EXACT | P=0.343N P=0.579N | P=0.500N P=0.359 |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) | 0/48 (0%) 0/48 (0%) 1/50 (2%) |
|ADJUSTED (b) | 11.7% 3.1% 7.7% | 0.0% 0.0% 2.2% |
|TERMINAL (d) | 2/24 (8%) 0/27 (0%) 2/26 (8%) | 0/25 (0%) 0/25 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 729 722 730 (T) | --- --- 491 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.376N P=0.276N P=0.474N | P=0.270 (e) P=0.492 |
|INCIDENTAL TUMOR | P=0.361N P=0.244N P=0.463N | P=0.350 (e) P=0.638 |
|LOGISTIC REGRESSION | P=0.365N P=0.247N P=0.486N | P=0.346 (e) P=0.670 |
|COCHRAN-ARMITAGE | P=0.395N | P=0.281 |
|FISHER EXACT | P=0.309N P=0.500N | (e) P=0.510 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 21/50 (42%) 23/50 (46%) | 2/48 (4%) 1/48 (2%) 4/50 (8%) |
|ADJUSTED (b) | 74.3% 64.5% 64.5% | 7.6% 4.0% 11.6% |
|TERMINAL (d) | 16/24 (67%) 16/27 (59%) 14/26 (54%) | 1/25 (4%) 1/25 (4%) 3/31 (10%) |
|FIRST INCIDENCE (DAYS) | 591 548 559 | 729 730 (T) 491 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.330N P=0.174N P=0.368N | P=0.297 P=0.504N P=0.413 |
|INCIDENTAL TUMOR | P=0.396N P=0.178N P=0.448N | P=0.288 P=0.556N P=0.412 |
|LOGISTIC REGRESSION | P=0.345N P=0.152N P=0.386N | P=0.236 P=0.520N P=0.353 |
|COCHRAN-ARMITAGE | P=0.456N | P=0.244 |
|FISHER EXACT | P=0.344N P=0.500N | P=0.500N P=0.359 |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Bone |
| Osteosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 3.7% 4.1% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 1/27 (4%) 0/26 (0%) | 0/25 (0%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | --- 730 (T) 386 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.150 P=0.523 P=0.237 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.188 P=0.523 P=0.277 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.160 P=0.523 P=0.318 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.145 | (e) |
|FISHER EXACT | P=0.500 P=0.247 | (e) (e) |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/48 (13%) 5/50 (10%) 0/47 (0%) | 1/44 (2%) 7/38 (18%) 4/42 (10%) |
|ADJUSTED (b) | 21.9% 15.2% 0.0% | 2.4% 26.8% 13.3% |
|TERMINAL (d) | 4/22 (18%) 3/27 (11%) 0/26 (0%) | 0/23 (0%) 5/22 (23%) 3/28 (11%) |
|FIRST INCIDENCE (DAYS) | 533 630 --- | 658 621 700 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.011N* P=0.388N P=0.013N* | P=0.270 P=0.027 * P=0.212 |
|INCIDENTAL TUMOR | P=0.026N* P=0.565N P=0.021N* | P=0.206 P=0.023 * P=0.139 |
|LOGISTIC REGRESSION | P=0.018N* P=0.461N P=0.018N* | P=0.189 P=0.018 * P=0.163 |
|COCHRAN-ARMITAGE | P=0.019N* | P=0.191 |
|FISHER EXACT | P=0.471N P=0.014N* | P=0.017 * P=0.166 |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/48 (13%) 6/50 (12%) 0/47 (0%) | 4/44 (9%) 3/38 (8%) 0/42 (0%) |
|ADJUSTED (b) | 18.3% 17.3% 0.0% | 14.1% 13.6% 0.0% |
|TERMINAL (d) | 2/22 (9%) 2/27 (7%) 0/26 (0%) | 2/23 (9%) 3/22 (14%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 455 320 --- | 633 730 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.019N* P=0.522N P=0.015N* | P=0.036N* P=0.532N P=0.052N |
|INCIDENTAL TUMOR | P=0.024N* P=0.504N P=0.031N* | P=0.039N* P=0.498N P=0.057N |
|LOGISTIC REGRESSION | P=0.037N* P=0.603 P=0.028N* | P=0.057N P=0.607N P=0.069N |
|COCHRAN-ARMITAGE | P=0.024N* | P=0.055N |
|FISHER EXACT | P=0.591N P=0.014N* | P=0.583N P=0.064N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/48 (25%) 11/50 (22%) 0/47 (0%) | 5/44 (11%) 10/38 (26%) 4/42 (10%) |
|ADJUSTED (b) | 37.6% 30.6% 0.0% | 16.1% 39.7% 13.3% |
|TERMINAL (d) | 6/22 (27%) 5/27 (19%) 0/26 (0%) | 2/23 (9%) 8/22 (36%) 3/28 (11%) |
|FIRST INCIDENCE (DAYS) | 455 320 --- | 633 621 700 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P=0.352N P<0.001N** | P=0.315N P=0.107 P=0.436N |
|INCIDENTAL TUMOR | P=0.001N** P=0.455N P<0.001N** | P=0.387N P=0.106 P=0.533N |
|LOGISTIC REGRESSION | P=0.001N** P=0.494N P<0.001N** | P=0.449N P=0.063 P=0.533N |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.443N |
|FISHER EXACT | P=0.455N P<0.001N** | P=0.072 P=0.530N |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/49 (2%) | 0/50 (0%) 0/48 (0%) 0/49 (0%) |
|ADJUSTED (b) | 8.3% 6.5% 3.4% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/24 (8%) 1/27 (4%) 0/26 (0%) | 0/25 (0%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 712 719 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.372N P=0.648N P=0.477N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.377N P=0.640N P=0.481N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.369N P=0.636N P=0.475N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.404N | (e) |
|FISHER EXACT | P=0.691N P=0.508N | (e) (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/49 (4%) | 1/50 (2%) 0/48 (0%) 0/49 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 7.7% | 4.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/27 (0%) 2/26 (8%) | 1/25 (4%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 730 (T) | 730 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.108 (e) P=0.255 | P=0.268N P=0.492N P=0.457N |
|INCIDENTAL TUMOR | P=0.108 (e) P=0.255 | P=0.268N P=0.492N P=0.457N |
|LOGISTIC REGRESSION | P=0.108 (e) P=0.255 | P=0.268N P=0.492N P=0.457N |
|COCHRAN-ARMITAGE | P=0.100 | P=0.300N |
|FISHER EXACT | (e) P=0.242 | P=0.510N P=0.505N |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/49 (6%) | 1/50 (2%) 0/48 (0%) 0/49 (0%) |
|ADJUSTED (b) | 8.3% 6.5% 10.9% | 4.0% 0.0% 0.0% |
|TERMINAL (d) | 2/24 (8%) 1/27 (4%) 2/26 (8%) | 1/25 (4%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 712 719 | 730 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.443 P=0.648N P=0.532 | P=0.268N P=0.492N P=0.457N |
|INCIDENTAL TUMOR | P=0.437 P=0.640N P=0.529 | P=0.268N P=0.492N P=0.457N |
|LOGISTIC REGRESSION | P=0.441 P=0.636N P=0.530 | P=0.268N P=0.492N P=0.457N |
|COCHRAN-ARMITAGE | P=0.404 | P=0.300N |
|FISHER EXACT | P=0.691N P=0.490 | P=0.510N P=0.505N |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 3.7% 7.7% | 0.0% 0.0% 3.2% |
|TERMINAL (d) | 0/24 (0%) 1/27 (4%) 2/26 (8%) | 0/25 (0%) 0/26 (0%) 1/31 (3%) |
|FIRST INCIDENCE (DAYS) | --- 730 (T) 730 (T) | --- --- 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.154 P=0.523 P=0.255 | P=0.309 (e) P=0.543 |
|INCIDENTAL TUMOR | P=0.154 P=0.523 P=0.255 | P=0.309 (e) P=0.543 |
|LOGISTIC REGRESSION | P=0.154 P=0.523 P=0.255 | P=0.309 (e) P=0.543 |
|COCHRAN-ARMITAGE | P=0.145 | P=0.275 |
|FISHER EXACT | P=0.500 P=0.247 | (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 3.7% 10.9% | 0.0% 0.0% 3.2% |
|TERMINAL (d) | 0/24 (0%) 1/27 (4%) 2/26 (8%) | 0/25 (0%) 0/26 (0%) 1/31 (3%) |
|FIRST INCIDENCE (DAYS) | --- 730 (T) 719 | --- --- 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.068 P=0.523 P=0.134 | P=0.309 (e) P=0.543 |
|INCIDENTAL TUMOR | P=0.069 P=0.523 P=0.137 | P=0.309 (e) P=0.543 |
|LOGISTIC REGRESSION | P=0.066 P=0.523 P=0.134 | P=0.309 (e) P=0.543 |
|COCHRAN-ARMITAGE | P=0.063 | P=0.275 |
|FISHER EXACT | P=0.500 P=0.121 | (e) P=0.500 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 4.2% 9.9% 0.0% | 0.0% 3.6% 0.0% |
|TERMINAL (d) | 1/24 (4%) 2/27 (7%) 0/26 (0%) | 0/25 (0%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 699 --- | --- 728 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.366N P=0.360 P=0.484N | P=0.708N P=0.500 (e) |
|INCIDENTAL TUMOR | P=0.371N P=0.360 P=0.484N | P=0.686 P=0.419 (e) |
|LOGISTIC REGRESSION | P=0.369N P=0.360 P=0.484N | P=0.723N P=0.494 (e) |
|COCHRAN-ARMITAGE | P=0.399N | P=0.725N |
|FISHER EXACT | P=0.309 P=0.500N | P=0.500 (e) |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 4.2% 13.5% 0.0% | 0.0% 3.6% 0.0% |
|TERMINAL (d) | 1/24 (4%) 3/27 (11%) 0/26 (0%) | 0/25 (0%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 699 --- | --- 728 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.379N P=0.225 P=0.484N | P=0.708N P=0.500 (e) |
|INCIDENTAL TUMOR | P=0.384N P=0.225 P=0.484N | P=0.686 P=0.419 (e) |
|LOGISTIC REGRESSION | P=0.380N P=0.228 P=0.484N | P=0.723N P=0.494 (e) |
|COCHRAN-ARMITAGE | P=0.415N | P=0.725N |
|FISHER EXACT | P=0.181 P=0.500N | P=0.500 (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 4.2% 13.5% 0.0% | 0.0% 3.6% 0.0% |
|TERMINAL (d) | 1/24 (4%) 3/27 (11%) 0/26 (0%) | 0/25 (0%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 699 --- | --- 728 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.379N P=0.225 P=0.484N | P=0.708N P=0.500 (e) |
|INCIDENTAL TUMOR | P=0.384N P=0.225 P=0.484N | P=0.686 P=0.419 (e) |
|LOGISTIC REGRESSION | P=0.380N P=0.228 P=0.484N | P=0.723N P=0.494 (e) |
|COCHRAN-ARMITAGE | P=0.415N | P=0.725N |
|FISHER EXACT | P=0.181 P=0.500N | P=0.500 (e) |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 7.2% 6.4% 5.8% |
|TERMINAL (d) | 0/24 (0%) 0/27 (0%) 0/26 (0%) | 1/25 (4%) 1/26 (4%) 1/31 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 727 665 686 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.559N P=0.689 P=0.651N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.534 P=0.628 P=0.631 |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.595 P=0.670 P=0.685 |
|COCHRAN-ARMITAGE | (e) | P=0.608 |
|FISHER EXACT | (e) (e) | P=0.691N P=0.691N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 11.1% 6.4% 5.8% |
|TERMINAL (d) | 0/24 (0%) 0/27 (0%) 0/26 (0%) | 2/25 (8%) 1/26 (4%) 1/31 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 727 665 686 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.365N P=0.499N P=0.439N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.473N P=0.562N P=0.546N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.432N P=0.534N P=0.512N |
|COCHRAN-ARMITAGE | (e) | P=0.418N |
|FISHER EXACT | (e) (e) | P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 6/50 (12%) 5/50 (10%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 19.4% 17.2% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/27 (0%) 0/26 (0%) | 3/25 (12%) 3/26 (12%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 661 687 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.013N* P=0.497N P=0.015N* |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.027N* P=0.612N P=0.027N* |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.018N* P=0.553N P=0.019N* |
|COCHRAN-ARMITAGE | (e) | P=0.016N* |
|FISHER EXACT | (e) (e) | P=0.500N P=0.013N* |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | 6/50 (12%) 5/50 (10%) 0/50 (0%) |
|ADJUSTED (b) | 4.2% 0.0% 0.0% | 19.4% 17.2% 0.0% |
|TERMINAL (d) | 1/24 (4%) 0/27 (0%) 0/26 (0%) | 3/25 (12%) 3/26 (12%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) --- --- | 661 687 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.259N P=0.477N P=0.484N | P=0.013N* P=0.497N P=0.015N* |
|INCIDENTAL TUMOR | P=0.259N P=0.477N P=0.484N | P=0.027N* P=0.612N P=0.027N* |
|LOGISTIC REGRESSION | P=0.259N P=0.477N P=0.484N | P=0.018N* P=0.553N P=0.019N* |
|COCHRAN-ARMITAGE | P=0.272N | P=0.016N* |
|FISHER EXACT | P=0.500N P=0.500N | P=0.500N P=0.013N* |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) | 28/50 (56%) 26/50 (52%) 31/50 (62%) |
|ADJUSTED (b) | 8.3% 12.4% 5.8% | 70.4% 69.0% 79.2% |
|TERMINAL (d) | 2/24 (8%) 2/27 (7%) 0/26 (0%) | 14/25 (56%) 15/26 (58%) 23/31 (74%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 644 635 | 428 456 448 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.568N P=0.402 P=0.663N | P=0.503N P=0.449N P=0.517N |
|INCIDENTAL TUMOR | P=0.551 P=0.346 P=0.676 | P=0.246 P=0.551N P=0.309 |
|LOGISTIC REGRESSION | P=0.584N P=0.390 P=0.681N | P=0.230 P=0.507N P=0.262 |
|COCHRAN-ARMITAGE | P=0.582 | P=0.297 |
|FISHER EXACT | P=0.339 P=0.691N | P=0.421N P=0.342 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 2/50 (4%) | 28/50 (56%) 26/50 (52%) 31/50 (62%) |
|ADJUSTED (b) | 12.5% 12.4% 5.8% | 70.4% 69.0% 79.2% |
|TERMINAL (d) | 3/24 (13%) 2/27 (7%) 0/26 (0%) | 14/25 (56%) 15/26 (58%) 23/31 (74%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 644 635 | 428 456 448 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.391N P=0.572 P=0.463N | P=0.503N P=0.449N P=0.517N |
|INCIDENTAL TUMOR | P=0.451N P=0.519 P=0.511N | P=0.246 P=0.551N P=0.309 |
|LOGISTIC REGRESSION | P=0.403N P=0.569 P=0.476N | P=0.230 P=0.507N P=0.262 |
|COCHRAN-ARMITAGE | P=0.427N | P=0.297 |
|FISHER EXACT | P=0.500 P=0.500N | P=0.421N P=0.342 |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 2/50 (4%) | 30/50 (60%) 29/50 (58%) 31/50 (62%) |
|ADJUSTED (b) | 12.5% 12.4% 5.8% | 74.0% 75.5% 79.2% |
|TERMINAL (d) | 3/24 (13%) 2/27 (7%) 0/26 (0%) | 15/25 (60%) 17/26 (65%) 23/31 (74%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 644 635 | 428 456 448 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.391N P=0.572 P=0.463N | P=0.350N P=0.510N P=0.377N |
|INCIDENTAL TUMOR | P=0.451N P=0.519 P=0.511N | P=0.387 P=0.502 P=0.457 |
|LOGISTIC REGRESSION | P=0.403N P=0.569 P=0.476N | P=0.369 P=0.548 P=0.407 |
|COCHRAN-ARMITAGE | P=0.427N | P=0.456 |
|FISHER EXACT | P=0.500 P=0.500N | P=0.500N P=0.500 |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 1/48 (2%) 0/49 (0%) |
|ADJUSTED (b) | 7.2% 0.0% 0.0% | 0.0% 3.8% 0.0% |
|TERMINAL (d) | 1/24 (4%) 0/27 (0%) 0/26 (0%) | 0/25 (0%) 1/26 (4%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 677 --- --- | --- 730 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.083N P=0.206N P=0.221N | P=0.691N P=0.508 (e) |
|INCIDENTAL TUMOR | P=0.086N P=0.201N P=0.231N | P=0.691N P=0.508 (e) |
|LOGISTIC REGRESSION | P=0.091N P=0.221N P=0.233N | P=0.691N P=0.508 (e) |
|COCHRAN-ARMITAGE | P=0.096N | P=0.727N |
|FISHER EXACT | P=0.247N P=0.253N | P=0.490 (e) |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 12/50 (24%) 13/50 (26%) | 23/50 (46%) 16/48 (33%) 21/48 (44%) |
|ADJUSTED (b) | 27.8% 32.1% 42.3% | 59.1% 50.4% 51.7% |
|TERMINAL (d) | 3/24 (13%) 5/27 (19%) 9/26 (35%) | 11/25 (44%) 11/26 (42%) 12/31 (39%) |
|FIRST INCIDENCE (DAYS) | 506 489 646 | 568 567 448 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.355 P=0.520 P=0.401 | P=0.264N P=0.148N P=0.293N |
|INCIDENTAL TUMOR | P=0.286 P=0.328 P=0.338 | P=0.517 P=0.145N P=0.500 |
|LOGISTIC REGRESSION | P=0.282 P=0.371 P=0.333 | P=0.523 P=0.163N P=0.551 |
|COCHRAN-ARMITAGE | P=0.278 | P=0.471N |
|FISHER EXACT | P=0.405 P=0.318 | P=0.141N P=0.492N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) | 3/50 (6%) 9/48 (19%) 2/48 (4%) |
|ADJUSTED (b) | 4.2% 6.0% 8.4% | 9.7% 26.9% 5.6% |
|TERMINAL (d) | 1/24 (4%) 1/27 (4%) 1/26 (4%) | 1/25 (4%) 4/26 (15%) 1/31 (3%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 644 387 | 700 564 675 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.248 P=0.548 P=0.333 | P=0.342N P=0.069 P=0.462N |
|INCIDENTAL TUMOR | P=0.235 P=0.458 P=0.350 | P=0.562N P=0.033 * P=0.646N |
|LOGISTIC REGRESSION | P=0.223 P=0.522 P=0.303 | P=0.426N P=0.048 * P=0.527N |
|COCHRAN-ARMITAGE | P=0.225 | P=0.417N |
|FISHER EXACT | P=0.500 P=0.309 | P=0.052 P=0.520N |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 14/50 (28%) 16/50 (32%) | 26/50 (52%) 25/48 (52%) 23/48 (48%) |
|ADJUSTED (b) | 31.2% 36.7% 48.3% | 64.3% 68.6% 55.4% |
|TERMINAL (d) | 4/24 (17%) 6/27 (22%) 10/26 (38%) | 12/25 (48%) 15/26 (58%) 13/31 (42%) |
|FIRST INCIDENCE (DAYS) | 506 489 387 | 568 564 448 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.232 P=0.453 P=0.268 | P=0.192N P=0.524N P=0.236N |
|INCIDENTAL TUMOR | P=0.165 P=0.243 P=0.214 | P=0.525 P=0.511 P=0.518 |
|LOGISTIC REGRESSION | P=0.157 P=0.297 P=0.188 | P=0.501N P=0.448 P=0.558N |
|COCHRAN-ARMITAGE | P=0.157 | P=0.381N |
|FISHER EXACT | P=0.322 P=0.184 | P=0.577 P=0.420N |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 10.6% 0.0% 9.7% | 0.0% 0.0% 2.9% |
|TERMINAL (d) | 2/24 (8%) 0/27 (0%) 2/26 (8%) | 0/25 (0%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 621 --- 559 | --- --- 699 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.563N P=0.105N P=0.631N | P=0.274 (e) P=0.494 |
|INCIDENTAL TUMOR | P=0.574 P=0.141N P=0.619 | P=0.198 (e) P=0.383 |
|LOGISTIC REGRESSION | P=0.588N P=0.113N P=0.660N | P=0.272 (e) P=0.495 |
|COCHRAN-ARMITAGE | P=0.589N | P=0.275 |
|FISHER EXACT | P=0.121N P=0.661N | (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 6/50 (12%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 11.9% 19.1% 14.5% | 0.0% 0.0% 2.5% |
|TERMINAL (d) | 1/24 (4%) 4/27 (15%) 3/26 (12%) | 0/25 (0%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 455 644 716 | --- --- 675 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.535N P=0.441 P=0.614N | P=0.291 (e) P=0.516 |
|INCIDENTAL TUMOR | P=0.569 P=0.323 P=0.623N | P=0.198 (e) P=0.383 |
|LOGISTIC REGRESSION | P=0.569N P=0.367 P=0.642N | P=0.276 (e) P=0.505 |
|COCHRAN-ARMITAGE | P=0.564 | P=0.275 |
|FISHER EXACT | P=0.370 P=0.643N | (e) P=0.500 |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 3.2% 3.7% 7.3% | 0.0% 3.8% 3.2% |
|TERMINAL (d) | 0/24 (0%) 1/27 (4%) 1/26 (4%) | 0/25 (0%) 1/26 (4%) 1/31 (3%) |
|FIRST INCIDENCE (DAYS) | 678 730 (T) 728 | --- 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.411 P=0.721N P=0.527 | P=0.402 P=0.508 P=0.543 |
|INCIDENTAL TUMOR | P=0.411 P=0.720N P=0.530 | P=0.402 P=0.508 P=0.543 |
|LOGISTIC REGRESSION | P=0.407 P=0.748N P=0.522 | P=0.402 P=0.508 P=0.543 |
|COCHRAN-ARMITAGE | P=0.386 | P=0.352 |
|FISHER EXACT | P=0.753N P=0.500 | P=0.500 P=0.500 |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 7/50 (14%) 9/50 (18%) | 0/50 (0%) 1/50 (2%) 3/50 (6%) |
|ADJUSTED (b) | 24.1% 22.6% 29.9% | 0.0% 3.8% 8.3% |
|TERMINAL (d) | 3/24 (13%) 5/27 (19%) 6/26 (23%) | 0/25 (0%) 1/26 (4%) 1/31 (3%) |
|FIRST INCIDENCE (DAYS) | 455 644 559 | --- 730 (T) 675 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.512 P=0.407N P=0.551 | P=0.080 P=0.508 P=0.140 |
|INCIDENTAL TUMOR | P=0.444 P=0.543N P=0.498 | P=0.046 * P=0.508 P=0.069 |
|LOGISTIC REGRESSION | P=0.467 P=0.490N P=0.510 | P=0.060 P=0.508 P=0.116 |
|COCHRAN-ARMITAGE | P=0.452 | P=0.062 |
|FISHER EXACT | P=0.500N P=0.500 | P=0.500 P=0.121 |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 5/50 (10%) 4/50 (8%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 16.2% 15.4% | 4.0% 6.4% 0.0% |
|TERMINAL (d) | 0/24 (0%) 3/27 (11%) 4/26 (15%) | 1/25 (4%) 1/26 (4%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | --- 644 730 (T) | 730 (T) 653 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.077 P=0.047 * P=0.071 | P=0.319N P=0.497 P=0.457N |
|INCIDENTAL TUMOR | P=0.067 P=0.034 * P=0.071 | P=0.365N P=0.463 P=0.457N |
|LOGISTIC REGRESSION | P=0.076 P=0.042 * P=0.071 | P=0.359N P=0.480 P=0.457N |
|COCHRAN-ARMITAGE | P=0.067 | P=0.350N |
|FISHER EXACT | P=0.028 * P=0.059 | P=0.500 P=0.500N |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 2.7% 6.4% 2.5% | 0.0% 3.8% 0.0% |
|TERMINAL (d) | 0/24 (0%) 1/27 (4%) 0/26 (0%) | 0/25 (0%) 1/26 (4%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 633 700 636 | --- 730 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.599N P=0.553 P=0.734N | P=0.691N P=0.508 (e) |
|INCIDENTAL TUMOR | P=0.551 P=0.473 P=0.661 | P=0.691N P=0.508 (e) |
|LOGISTIC REGRESSION | P=0.619 P=0.506 P=0.762 | P=0.691N P=0.508 (e) |
|COCHRAN-ARMITAGE | P=0.620 | P=0.725N |
|FISHER EXACT | P=0.500 P=0.753N | P=0.500 (e) |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.4% 0.0% 0.0% | 3.3% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/27 (0%) 0/26 (0%) | 0/25 (0%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 621 --- --- | 727 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.085N P=0.212N P=0.223N | P=0.293N P=0.507N P=0.493N |
|INCIDENTAL TUMOR | P=0.120N P=0.274N P=0.278N | P=0.384N P=0.581N P=0.617N |
|LOGISTIC REGRESSION | P=0.096N P=0.250N P=0.238N | P=0.297N P=0.508N P=0.500N |
|COCHRAN-ARMITAGE | P=0.095N | P=0.296N |
|FISHER EXACT | P=0.247N P=0.247N | P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 7/50 (14%) 5/50 (10%) | 2/50 (4%) 3/50 (6%) 0/50 (0%) |
|ADJUSTED (b) | 2.7% 21.9% 17.5% | 6.9% 10.1% 0.0% |
|TERMINAL (d) | 0/24 (0%) 4/27 (15%) 4/26 (15%) | 1/25 (4%) 2/26 (8%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 633 644 636 | 709 653 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.127 P=0.054 P=0.128 | P=0.169N P=0.502 P=0.223N |
|INCIDENTAL TUMOR | P=0.087 P=0.030 * P=0.081 | P=0.221N P=0.438 P=0.276N |
|LOGISTIC REGRESSION | P=0.109 P=0.039 * P=0.109 | P=0.202N P=0.469 P=0.243N |
|COCHRAN-ARMITAGE | P=0.101 | P=0.192N |
|FISHER EXACT | P=0.030 * P=0.102 | P=0.500 P=0.247N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 2.7% 6.4% 2.5% | 3.0% 3.8% 0.0% |
|TERMINAL (d) | 0/24 (0%) 1/27 (4%) 0/26 (0%) | 0/25 (0%) 1/26 (4%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 633 700 636 | 709 730 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.599N P=0.553 P=0.734N | P=0.320N P=0.756N P=0.512N |
|INCIDENTAL TUMOR | P=0.551 P=0.473 P=0.661 | P=0.376N P=0.721 P=0.617N |
|LOGISTIC REGRESSION | P=0.619 P=0.506 P=0.762 | P=0.342N P=0.747 P=0.507N |
|COCHRAN-ARMITAGE | P=0.620 | P=0.336N |
|FISHER EXACT | P=0.500 P=0.753N | P=0.753N P=0.500N |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 45/50 (90%) 21/50 (42%) | |
|ADJUSTED (b) | 100.0% 100.0% 61.8% | |
|TERMINAL (d) | 24/24 (100%) 27/27 (100%) 14/26 (54%) | |
|FIRST INCIDENCE (DAYS) | 455 548 559 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P=0.162N P<0.001N** | |
|INCIDENTAL TUMOR | P<0.001N** P=0.277N P<0.001N** | |
|LOGISTIC REGRESSION | P<0.001N** P=0.221N P<0.001N** | |
|COCHRAN-ARMITAGE | P<0.001N** | |
|FISHER EXACT | P=0.357N P<0.001N** | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 7/50 (14%) 6/50 (12%) | 3/50 (6%) 3/50 (6%) 4/50 (8%) |
|ADJUSTED (b) | 12.5% 22.6% 20.1% | 11.4% 10.2% 12.9% |
|TERMINAL (d) | 3/24 (13%) 5/27 (19%) 4/26 (15%) | 2/25 (8%) 0/26 (0%) 4/31 (13%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 561 639 | 729 726 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.241 P=0.207 P=0.285 | P=0.514 P=0.656N P=0.611 |
|INCIDENTAL TUMOR | P=0.205 P=0.180 P=0.252 | P=0.370 P=0.541 P=0.557 |
|LOGISTIC REGRESSION | P=0.227 P=0.200 P=0.278 | P=0.434 P=0.656 P=0.547 |
|COCHRAN-ARMITAGE | P=0.205 | P=0.423 |
|FISHER EXACT | P=0.159 P=0.243 | P=0.661N P=0.500 |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) | 4/50 (8%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 8.4% 3.8% | 13.8% 7.7% 6.5% |
|TERMINAL (d) | 0/24 (0%) 1/27 (4%) 1/26 (4%) | 3/25 (12%) 2/26 (8%) 2/31 (6%) |
|FIRST INCIDENCE (DAYS) | --- 656 730 (T) | 481 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.394 P=0.159 P=0.516 | P=0.199N P=0.326N P=0.262N |
|INCIDENTAL TUMOR | P=0.391 P=0.158 P=0.516 | P=0.171N P=0.271N P=0.212N |
|LOGISTIC REGRESSION | P=0.373 P=0.121 P=0.516 | P=0.276N P=0.344N P=0.339N |
|COCHRAN-ARMITAGE | P=0.367 | P=0.265N |
|FISHER EXACT | P=0.121 P=0.500 | P=0.339N P=0.339N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 9/50 (18%) 7/50 (14%) | 7/50 (14%) 5/50 (10%) 6/50 (12%) |
|ADJUSTED (b) | 12.5% 26.4% 23.7% | 24.5% 17.1% 19.4% |
|TERMINAL (d) | 3/24 (13%) 5/27 (19%) 5/26 (19%) | 5/25 (20%) 2/26 (8%) 6/31 (19%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 561 639 | 481 726 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.176 P=0.100 P=0.193 | P=0.329N P=0.372N P=0.356N |
|INCIDENTAL TUMOR | P=0.145 P=0.084 P=0.168 | P=0.408N P=0.418N P=0.354N |
|LOGISTIC REGRESSION | P=0.155 P=0.076 P=0.189 | P=0.476N P=0.425N P=0.527N |
|COCHRAN-ARMITAGE | P=0.140 | P=0.453N |
|FISHER EXACT | P=0.061 P=0.159 | P=0.380N P=0.500N |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 7.4% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 2/27 (7%) 0/26 (0%) | 0/25 (0%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | --- 730 (T) --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.677 P=0.264 (e) | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.677 P=0.264 (e) | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.677 P=0.264 (e) | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.658 | (e) |
|FISHER EXACT | P=0.247 (e) | (e) (e) |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 9.7% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 2/27 (7%) 0/26 (0%) | 0/25 (0%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | --- 656 --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.644N P=0.150 (e) | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.646N P=0.152 (e) | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.636 P=0.133 (e) | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.623 | (e) |
|FISHER EXACT | P=0.121 (e) | (e) (e) |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | | 0.0% 0.0% 6.5% |
|TERMINAL (d) | | 0/25 (0%) 0/26 (0%) 2/31 (6%) |
|FIRST INCIDENCE (DAYS) | | --- --- 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.120 (e) P=0.286 |
|INCIDENTAL TUMOR | | P=0.120 (e) P=0.286 |
|LOGISTIC REGRESSION | | P=0.120 (e) P=0.286 |
|COCHRAN-ARMITAGE | | P=0.094 |
|FISHER EXACT | | (e) P=0.247 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 10/50 (20%) 16/50 (32%) 10/50 (20%) |
|ADJUSTED (b) | | 32.8% 47.2% 30.2% |
|TERMINAL (d) | | 6/25 (24%) 9/26 (35%) 8/31 (26%) |
|FIRST INCIDENCE (DAYS) | | 633 601 700 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.377N P=0.142 P=0.456N |
|INCIDENTAL TUMOR | | P=0.531 P=0.094 P=0.593 |
|LOGISTIC REGRESSION | | P=0.543 P=0.081 P=0.574 |
|COCHRAN-ARMITAGE | | P=0.522N |
|FISHER EXACT | | P=0.127 P=0.598N |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | | 6.1% 2.0% 2.8% |
|TERMINAL (d) | | 1/25 (4%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | | 620 423 693 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.386N P=0.511N P=0.483N |
|INCIDENTAL TUMOR | | P=0.394N P=0.372N P=0.575N |
|LOGISTIC REGRESSION | | P=0.342N P=0.381N P=0.496N |
|COCHRAN-ARMITAGE | | P=0.393N |
|FISHER EXACT | | P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 11/50 (22%) 17/50 (34%) 11/50 (22%) |
|ADJUSTED (b) | | 34.3% 48.3% 32.1% |
|TERMINAL (d) | | 6/25 (24%) 9/26 (35%) 8/31 (26%) |
|FIRST INCIDENCE (DAYS) | | 620 423 693 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.385N P=0.149 P=0.462N |
|INCIDENTAL TUMOR | | P=0.521 P=0.124 P=0.549 |
|LOGISTIC REGRESSION | | P=0.539 P=0.101 P=0.560 |
|COCHRAN-ARMITAGE | | P=0.521N |
|FISHER EXACT | | P=0.133 P=0.595N |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 5.1% 0.0% 2.2% | 2.7% 2.5% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/27 (0%) 0/26 (0%) | 0/25 (0%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 554 --- 532 | 691 621 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.349N P=0.219N P=0.492N | P=0.346N P=0.737 P=0.505N |
|INCIDENTAL TUMOR | P=0.376N P=0.274N P=0.516N | P=0.426N P=0.765 P=0.617N |
|LOGISTIC REGRESSION | P=0.342N P=0.250N P=0.484N | P=0.323N P=0.747N P=0.502N |
|COCHRAN-ARMITAGE | P=0.355N | P=0.336N |
|FISHER EXACT | P=0.247N P=0.500N | P=0.753N P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.4% 2.0% 0.0% | 3.3% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/27 (0%) 0/26 (0%) | 0/25 (0%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 621 483 --- | 727 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.137N P=0.468N P=0.223N | P=0.293N P=0.507N P=0.493N |
|INCIDENTAL TUMOR | P=0.166N P=0.619N P=0.278N | P=0.384N P=0.581N P=0.617N |
|LOGISTIC REGRESSION | P=0.138N P=0.525N P=0.238N | P=0.297N P=0.508N P=0.500N |
|COCHRAN-ARMITAGE | P=0.145N | P=0.296N |
|FISHER EXACT | P=0.500N P=0.247N | P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 25
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.4% 2.0% 2.6% | 3.3% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/27 (0%) 0/26 (0%) | 0/25 (0%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 621 483 646 | 727 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.360N P=0.468N P=0.469N | P=0.293N P=0.507N P=0.493N |
|INCIDENTAL TUMOR | P=0.389N P=0.619N P=0.532N | P=0.384N P=0.581N P=0.617N |
|LOGISTIC REGRESSION | P=0.373N P=0.525N P=0.502N | P=0.297N P=0.508N P=0.500N |
|COCHRAN-ARMITAGE | P=0.380N | P=0.296N |
|FISHER EXACT | P=0.500N P=0.500N | P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 14/50 (28%) 15/50 (30%) | 13/50 (26%) 13/50 (26%) 9/50 (18%) |
|ADJUSTED (b) | 57.0% 39.2% 38.1% | 32.6% 33.7% 21.9% |
|TERMINAL (d) | 8/24 (33%) 7/27 (26%) 4/26 (15%) | 2/25 (8%) 5/26 (19%) 2/31 (6%) |
|FIRST INCIDENCE (DAYS) | 554 561 413 | 481 390 513 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.053N P=0.037N* P=0.076N | P=0.201N P=0.545 P=0.243N |
|INCIDENTAL TUMOR | P=0.069N P=0.046N* P=0.090N | P=0.307N P=0.538N P=0.454N |
|LOGISTIC REGRESSION | P=0.086N P=0.070N P=0.122N | P=0.204N P=0.447N P=0.304N |
|COCHRAN-ARMITAGE | P=0.055N | P=0.200N |
|FISHER EXACT | P=0.048N* P=0.074N | P=0.590N P=0.235N |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 26
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 9.3% 17.2% 8.6% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/24 (4%) 2/27 (7%) 1/26 (4%) | 0/25 (0%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 506 630 635 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.538N P=0.320 P=0.622N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.534 P=0.245 P=0.629 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.564 P=0.242 P=0.659 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.564 | (e) |
|FISHER EXACT | P=0.243 P=0.661N | (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 3.7% 4.1% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 1/27 (4%) 0/26 (0%) | 0/25 (0%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | --- 730 (T) 386 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.150 P=0.523 P=0.237 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.188 P=0.523 P=0.277 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.160 P=0.523 P=0.318 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.145 | (e) |
|FISHER EXACT | P=0.500 P=0.247 | (e) (e) |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 27
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 3.7% 4.1% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 1/27 (4%) 0/26 (0%) | 0/25 (0%) 0/26 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | --- 730 (T) 386 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.150 P=0.523 P=0.237 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.188 P=0.523 P=0.277 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.160 P=0.523 P=0.318 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.145 | (e) |
|FISHER EXACT | P=0.500 P=0.247 | (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 47/50 (94%) 40/50 (80%) | 43/50 (86%) 41/50 (82%) 42/50 (84%) |
|ADJUSTED (b) | 100.0% 100.0% 95.1% | 91.4% 93.2% 93.3% |
|TERMINAL (d) | 24/24 (100%) 27/27 (100%) 24/26 (92%) | 21/25 (84%) 23/26 (88%) 28/31 (90%) |
|FIRST INCIDENCE (DAYS) | 455 489 559 | 428 456 448 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.032N* P=0.165N P=0.043N* | P=0.199N P=0.471N P=0.221N |
|INCIDENTAL TUMOR | P<0.001N** P=0.362N P=0.003N** | P=0.418 P=0.580 P=0.536 |
|LOGISTIC REGRESSION | P<0.001N** P=0.224N P=0.002N** | P=0.504 P=0.618 P=0.595 |
|COCHRAN-ARMITAGE | P=0.002N** | P=0.458N |
|FISHER EXACT | P=0.309N P=0.004N** | P=0.393N P=0.500N |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 28
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.13% 0.25% | UNTREATD 0.06% 0.13% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 37/50 (74%) 31/50 (62%) 30/50 (60%) | 31/50 (62%) 28/50 (56%) 18/50 (36%) |
|ADJUSTED (b) | 78.2% 68.2% 66.4% | 69.5% 64.6% 40.8% |
|TERMINAL (d) | 14/24 (58%) 13/27 (48%) 12/26 (46%) | 12/25 (48%) 12/26 (46%) 6/31 (19%) |
|FIRST INCIDENCE (DAYS) | 455 320 386 | 481 390 412 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.111N P=0.115N P=0.131N | P=0.015N* P=0.421N P=0.019N* |
|INCIDENTAL TUMOR | P=0.100N P=0.162N P=0.116N | P=0.016N* P=0.348N P=0.028N* |
|LOGISTIC REGRESSION | P=0.101N P=0.184N P=0.153N | P=0.006N** P=0.278N P=0.012N* |
|COCHRAN-ARMITAGE | P=0.085N | P=0.006N** |
|FISHER EXACT | P=0.142N P=0.101N | P=0.342N P=0.008N** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 50/50 (100%) 48/50 (96%) | 49/50 (98%) 48/50 (96%) 46/50 (92%) |
|ADJUSTED (b) | 100.0% 100.0% 97.9% | 98.0% 98.0% 95.8% |
|TERMINAL (d) | 24/24 (100%) 27/27 (100%) 25/26 (96%) | 24/25 (96%) 25/26 (96%) 29/31 (94%) |
|FIRST INCIDENCE (DAYS) | 455 320 386 | 428 390 412 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.285N P=0.302N P=0.315N | P=0.123N P=0.533N P=0.138N |
|INCIDENTAL TUMOR | P=0.418N P=0.638 P=0.545N | P=0.214N P=0.587N P=0.315N |
|LOGISTIC REGRESSION | P=0.380N P=0.364 P=0.503N | P=0.149N P=0.535N P=0.243N |
|COCHRAN-ARMITAGE | P=0.377N | P=0.119N |
|FISHER EXACT | P=0.500 P=0.500N | P=0.500N P=0.181N |
|=================================================================================================================================|
DATE: 09/07/94 EXPERIMENT: 05051 TEST: 01 PAGE 29
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROFURANTOIN
TERMINAL SACRIFICE AT 105 WEEKS
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(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. The incidental tumor
test regards these lesions as non-fatal. Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fisher's 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).
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