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TDMS Study 05087-01 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Battelle Columbus                                         DATE: 09/11/94   
EXP: 05087                       TRIAMTERENE                   TIME: 11:30:08   
TEST: 01              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: M. RYAN                         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: 11:30:08  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 56042B  
CONT: N01-ES-45041                                             CAS: 396-01-0   
PATHOLOGIST: M. RYAN                         S. EUSTIS                         

                                    TRIAMTERENE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 22     CENSORED DEATHS 23   TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      336   470   484   488   508   530   539   584   617   624                 |
 |      645   653   655   659   675   681   702   709   714   719                 |
 |      725   726                                                                 |
 |  CENSORED DEATHS                                                               |
 |      83    83    83    93    93    94    94    94    95    95                  |
 |      96    96    96    456   456   456   456   456   456   456                 |
 |      456   456   456                                                           |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 150 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 25     CENSORED DEATHS 20   TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      324   366   539   542   610   610   611   611   617   619                 |
 |      640   652   653   655   659   660   674   674   683   702                 |
 |      702   710   713   715   722                                               |
 |  CENSORED DEATHS                                                               |
 |      93    94    94    94    94    95    96    96    96    96                  |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 300 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 31     CENSORED DEATHS 20   TERMINAL 19        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      531   539   541   552   572   592   617   626   626   635                 |
 |      649   666   668   670   671   672   680   688   691   693                 |
 |      693   694   698   701   702   702   705   713   718   719                 |
 |      726                                                                       |
 |  CENSORED DEATHS                                                               |
 |      93    93    94    94    94    95    96    96    96    96                  |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                                    TRIAMTERENE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 600 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 23     CENSORED DEATHS 20   TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      368   508   519   522   542   558   589   592   616   634                 |
 |      645   653   668   674   675   680   687   695   702   703                 |
 |      709   712   715                                                           |
 |  CENSORED DEATHS                                                               |
 |      93    93    93    94    94    95    95    95    95    96                  |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                                    TRIAMTERENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0  98.2  98.2  94.0  85.4  83.3  70.5  53.4      |
 |           |                                                                    |
 |           |                                                                    |
 |150 PPM    |   100.0 100.0 100.0  98.3  96.7  96.7  92.6  92.6  68.5  50.3      |
 |           |                                                                    |
 |           |                                                                    |
 |300 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0  94.0  88.0  78.0  38.0      |
 |           |                                                                    |
 |           |                                                                    |
 |600 PPM    |   100.0 100.0 100.0 100.0  98.3  98.3  90.3  84.3  76.3  54.2      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        150 PPM      300 PPM      600 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       53.4%        50.3%        38.0%        54.2%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=1.000N     P=0.901      P=0.287      P=1.000N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       611.0        626.5        656.5        624.6    |
 |NATURAL DEATHS (C)      |       (22.4)       (19.6)       (10.5)       (18.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       534.6        562.8        567.3        565.0    |
 |(STANDARD ERROR)        |       (28.5)       (26.2)       (25.8)       (26.2)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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 RATS
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 21     CENSORED DEATHS 20   TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      451   534   554   571   573   596   660   671   673   676                 |
 |      676   680   698   704   704   704   705   707   708   715                 |
 |      725                                                                       |
 |  CENSORED DEATHS                                                               |
 |      93    93    94    94    94    95    95    96    96    96                  |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 150 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 16     CENSORED DEATHS 20   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      476   522   592   600   611   643   662   666   676   700                 |
 |      701   708   708   715   715   719                                         |
 |  CENSORED DEATHS                                                               |
 |      93    93    93    93    94    95    95    95    95    95                  |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 300 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 16     CENSORED DEATHS 20   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      378   383   397   619   628   635   652   662   680   682                 |
 |      689   689   696   704   707   723                                         |
 |  CENSORED DEATHS                                                               |
 |      93    93    93    94    94    95    95    96    96    96                  |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                                    TRIAMTERENE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 600 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 21     CENSORED DEATHS 20   TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      466   509   530   541   542   589   619   620   620   634                 |
 |      647   648   648   685   695   698   698   707   707   709                 |
 |      715                                                                       |
 |  CENSORED DEATHS                                                               |
 |      93    93    93    94    94    95    95    95    96    96                  |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                                    TRIAMTERENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0 100.0 100.0  98.3  96.3  88.3  86.3  58.2      |
 |           |                                                                    |
 |           |                                                                    |
 |150 PPM    |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  92.0  86.0  68.0      |
 |           |                                                                    |
 |           |                                                                    |
 |300 PPM    |   100.0 100.0 100.0 100.0  95.0  95.0  95.0  95.0  84.9  68.7      |
 |           |                                                                    |
 |           |                                                                    |
 |600 PPM    |   100.0 100.0 100.0 100.0 100.0  98.0  90.0  88.0  74.0  58.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        150 PPM      300 PPM      600 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       58.2%        68.0%        68.7%        58.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.722      P=0.383N     P=0.455N     P=0.985  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       651.7        650.9        620.3        629.9    |
 |NATURAL DEATHS (C)      |       (16.3)       (18.3)       (30.0)       (16.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       576.2        581.4        574.5        569.6    |
 |(STANDARD ERROR)        |       (26.4)       (26.6)       (26.9)       (26.2)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        150 PPM          = 2
                                                        300 PPM          = 3
                                                        600 PPM          = 4

------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------

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

      |
      |
  100 + 1                                                   21    4                         3
      |                                                     21    2                1    4  432
      |                                                                            1 1       223
      |                                                                              1  1  4  23  3      2
   90 +                                                                                 1   1 4 4 3   3
      |                                                                                     11  4     3   3
P     |                                                                                      1      1 4  223
E     |                                                                                             1    4133
R  80 +                                                                                                   11321
C     |                                                                                                      211  3
E     |                                                                                                           44
N     |                                                                                                        1 1
T  70 +                                                                                                          1 14
      |                                                                                                          23114
S     |                                                                                                            213411
U     |                                                                                                             2  2
R  60 +                                                                                                                411
V     |                                                                                                              332211
I     |                                                                                                               3322  4
V     |                                                                                                                  21 1
A  50 +                                                                                                                   2 2
L     |
      |                                                                                                                333
      |
   40 +                                                                                                                  33
      |                                                                                                                   3 3
      |
      |
   30 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 44 obs hidden.

                                                            TRIAMTERENE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        150 PPM          = 2
                                                        300 PPM          = 3
                                                        600 PPM          = 4

----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------

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

      |
      |
  100 + 1                                                          3            1 42
      |                                                            3 3          1            1
      |                                                                           42    4  2
      |                                                              3 3                4  241  1     2
   95 +                                                                3                                  3
      |                                                                                     4 4 1 1   22
      |                                                                                                2 233
      |                                                                                                    33
   90 +                                                                                       4   1   41 2   2
      |                                                                                                1    3  3 1
P     |                                                                                               4   4  2 3 2
E     |                                                                                                          11
R  85 +                                                                                                          3  3
C     |                                                                                                           11
E     |                                                                                                   4 4      2  2
N     |                                                                                                             33
T  80 +                                                                                                     4 4       22
      |                                                                                                            11
S     |                                                                                                                22
U     |                                                                                                             131
R  75 +                                                                                                               33
V     |                                                                                                       4     4 1122
I     |                                                                                                             4 4
V     |                                                                                                                3  3
A  70 +
L     |                                                                                                                   3 3
      |                                                                                                                  2  2
      |                                                                                                               44
   65 +
      |                                                                                                                11
      |                                                                                                                411
      |
   60 +                                                                                                                 411
      |                                                                                                                   1 1
      |                                                                                                                  4  4
      |
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 11 obs hidden.