National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/3615

TDMS Study 05087-02 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Battelle Columbus                                         DATE: 09/11/94   
EXP: 05087                       TRIAMTERENE                   TIME: 13:47:47   
TEST: 02              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 56042B   
CONT: N01-ES-45041                                             CAS: 396-01-0    
PATHOLOGIST: L. MEZZA                        S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Battelle Columbus                                         DATE: 09/11/94  
EXP: 05087                       TRIAMTERENE                   TIME: 13:47:47  
TEST: 02              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 56042B  
CONT: N01-ES-45041                                             CAS: 396-01-0   
PATHOLOGIST: L. MEZZA                        S. EUSTIS                         

                                    TRIAMTERENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0PPM                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 3      CENSORED DEATHS 20   TERMINAL 47        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      585   623   690                                                           |
 |  CENSORED DEATHS                                                               |
 |      93    93    93    94    94    95    95    95    96    96                  |
 |      456   456   456   456   456   456   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 100PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 5      CENSORED DEATHS 20   TERMINAL 45        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      522   557   599   601   681                                               |
 |  CENSORED DEATHS                                                               |
 |      93    93    94    94    94    95    95    96    96    96                  |
 |      456   456   456   456   456   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 200PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 4      CENSORED DEATHS 20   TERMINAL 46        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      617   641   682   706                                                     |
 |  CENSORED DEATHS                                                               |
 |      93    94    94    94    94    95    96    96    96    96                  |
 |      456   456   456   456   456   456   457   457   457   457                 |
 |                                                                                |
 ==================================================================================

                                    TRIAMTERENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 400PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 14     CENSORED DEATHS 10   TERMINAL 46        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      283   284   284   284   284   285   285   285   286   286                 |
 |      286   288   620   711                                                     |
 |  CENSORED DEATHS                                                               |
 |      93    93    93    93    94    95    95    95    95    96                  |
 |                                                                                |
 ==================================================================================

                                    TRIAMTERENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0PPM       |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0  96.0  94.0      |
 |           |                                                                    |
 |           |                                                                    |
 |100PPM     |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  92.0  92.0  90.0      |
 |           |                                                                    |
 |           |                                                                    |
 |200PPM     |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  92.0      |
 |           |                                                                    |
 |           |                                                                    |
 |400PPM     |   100.0 100.0 100.0  80.0  80.0  80.0  80.0  80.0  78.3  76.7      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0PPM         100PPM       200PPM       400PPM   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       94.0%        90.0%        92.0%        76.7%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.002      P=0.685      P=1.000      P=0.010  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       632.7        592.0        661.5        339.4    |
 |NATURAL DEATHS (C)      |       (30.7)       (26.6)       (20.0)       (37.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       595.3        589.7        595.6        560.4    |
 |(STANDARD ERROR)        |       (27.1)       (27.0)       (27.1)       (30.2)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)

                                    TRIAMTERENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0PPM                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 12     CENSORED DEATHS 20   TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      23    114   362   431   494   509   530   589   696   711                 |
 |      723   725                                                                 |
 |  CENSORED DEATHS                                                               |
 |      93    93    93    94    94    95    96    96    96    96                  |
 |      456   456   456   456   456   456   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 100PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 7      CENSORED DEATHS 20   TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      250   579   629   639   664   670   683                                   |
 |  CENSORED DEATHS                                                               |
 |      93    93    93    93    94    95    95    96    96    96                  |
 |      456   456   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 200PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 7      CENSORED DEATHS 20   TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      490   528   560   586   660   677   712                                   |
 |  CENSORED DEATHS                                                               |
 |      93    94    94    94    94    95    95    95    96    96                  |
 |      456   456   456   456   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================

                                    TRIAMTERENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 400PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 17     CENSORED DEATHS 10   TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      280   283   284   285   522   579   585   600   613   623                 |
 |      629   645   690   703   704   705   712                                   |
 |  CENSORED DEATHS                                                               |
 |      93    93    94    94    94    95    95    95    95    96                  |
 |                                                                                |
 ==================================================================================

                                    TRIAMTERENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0PPM       |    98.6  96.9  96.9  95.2  95.2  93.6  87.5  85.4  85.4  77.3      |
 |           |                                                                    |
 |           |                                                                    |
 |100PPM     |   100.0 100.0  98.3  98.3  98.3  98.3  98.3  96.3  90.3  86.3      |
 |           |                                                                    |
 |           |                                                                    |
 |200PPM     |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  92.0  90.0  86.0      |
 |           |                                                                    |
 |           |                                                                    |
 |400PPM     |   100.0 100.0 100.0  93.3  93.3  93.3  91.7  86.7  80.0  71.7      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0PPM         100PPM       200PPM       400PPM   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       77.3%        86.3%        86.0%        71.7%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.308      P=0.286N     P=0.284N     P=0.672  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       492.3        587.7        601.9        555.4    |
 |NATURAL DEATHS (C)      |       (67.0)       (57.8)       (31.3)       (39.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       558.8        585.3        586.7        596.2    |
 |(STANDARD ERROR)        |       (28.8)       (27.3)       (26.9)       (27.8)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)

                                                            TRIAMTERENE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0PPM             = 1
                                                        100PPM           = 2
                                                        200PPM           = 3
                                                        400PPM           = 4

------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------

                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.

        |
  100.0 +1                                            4                                     2        1     3
        |
        |
        |                                                                                   2    2   1     1  3
   97.5 +
        |
        |                                                                                        2      2  1  3      31
        |
   95.0 +
        |
        |                                                                                                            31 3    1
        |
P  92.5 +
E       |                                                                                               2            2  3    3
R       |
C       |
E  90.0 +                                                                                                            2       2
N       |
T       |
        |
S  87.5 +
U       |
R       |
V       |
I  85.0 +
V       |
A       |
L       |
   82.5 +
        |                                             44
        |
        |
   80.0 +                                              4                                                   4
        |
        |
        |                                                                                                  4             4
   77.5 +
        |                                                                                                                4   4
        |
        |
   75.0 +
        |
        -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-
         0         10         20         30         40         50         60         70         80         90         100        110

                                                                    WEEK

NOTE: 4 obs hidden.

                                                            TRIAMTERENE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0PPM             = 1
                                                        100PPM           = 2
                                                        200PPM           = 3
                                                        400PPM           = 4

----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------

                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.

      |
      |
  100 + 1   1                                   2   4                                3
      |     1              1                    2   44                                             2
      |                    1                                     1                   3      3
      |                                                                                     3   3  2       2
P  95 +                                                          1          1
E     |                                              4                      1         1    4    3   3      2 2
R     |                                                                                             3        2   2
C     |                                                                               1 1  4       4
E  90 +                                                                                 1   1      44            223
N     |                                                                                             4  4          2 2
T     |                                                                                     1         1            3    3
      |                                                                                                4 4          2   3   2
S  85 +                                                                                               1  44           1
U     |                                                                                                   44          1 1
R     |
V     |                                                                                                    4  4         1 1
I  80 +                                                                                                       4      4
V     |                                                                                                              4 4
A     |                                                                                                                   1 1
L     |
   75 +
      |                                                                                                                44
      |
      |                                                                                                                 4   4
   70 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 6 obs hidden.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.