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TDMS Study 05182-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: TSI Mason Research                                     PHENOLPHTHALEIN                                    DATE: 04/04/96       
EXPERIMENT: 05182 TEST: 03                                                                                     TIME: 03:26:11       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-05302                              ROUTE: DOSED FEED                                              NTP C#: 55798B       
PATHOLOGIST: VOELKER, FRANK                  KOVATCH, ROBERT                                                   CAS: 77-09-8         
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: TSI Mason Research                                     PHENOLPHTHALEIN                                    DATE: 04/04/96      
EXPERIMENT: 05182 TEST: 03                                                                                     TIME: 03:26:11      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-05302                              ROUTE: DOSED FEED                                              NTP C#: 55798B      
PATHOLOGIST: VOELKER, FRANK                  KOVATCH, ROBERT                                                   CAS: 77-09-8        
                                  PHENOLPHTHALEIN

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 29     CENSORED DEATHS 0    TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      238   330   407   486   490   498   506   520   529   534                 |
 |      553   561   571   577   598   601   608   614   615   617                 |
 |      643   649   671   685   704   708   715   724   727                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 12000   PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 35     CENSORED DEATHS 0    TERMINAL 15        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      458   470   485   531   538   543   558   561   561   577                 |
 |      591   592   594   610   614   618   624   626   632   633                 |
 |      636   638   646   650   670   679   685   691   693   694                 |
 |      701   710   715   723   728                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 25000   PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 35     CENSORED DEATHS 0    TERMINAL 15        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      372   383   416   444   482   584   591   601   622   623                 |
 |      623   632   633   634   636   645   654   661   661   664                 |
 |      666   670   671   671   681   681   692   697   698   701                 |
 |      704   710   713   720   727                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  PHENOLPHTHALEIN

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 50000   PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 37     CENSORED DEATHS 0    TERMINAL 13        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      485   524   528   541   542   563   570   585   591   594                 |
 |      612   622   624   626   633   636   645   652   654   659                 |
 |      664   664   665   668   671   673   673   685   693   696                 |
 |      700   710   711   717   717   718   720                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  PHENOLPHTHALEIN

                       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  98.0  96.0  94.0  94.0  80.0  68.0  56.0  42.0      |
 |           |                                                                    |
 |           |                                                                    |
 |12000   PPM|   100.0 100.0 100.0 100.0 100.0  94.0  88.0  74.0  52.0  30.0      |
 |           |                                                                    |
 |           |                                                                    |
 |25000   PPM|   100.0 100.0 100.0 100.0  94.0  90.0  90.0  84.0  60.0  30.0      |
 |           |                                                                    |
 |           |                                                                    |
 |50000   PPM|   100.0 100.0 100.0 100.0 100.0  98.0  90.0  80.0  54.0  26.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        12000   PPM  25000   PPM  50000   P|M
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       42.0%        30.0%        30.0%        26.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.463      P=0.492      P=0.626      P=0.405  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       575.1        619.3        627.5        638.7    |
 |NATURAL DEATHS (C)      |       (21.4)       (12.2)       (16.0)       (10.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       639.8        652.2        658.0        662.2    |
 |(STANDARD ERROR)        |       (16.4)       (11.1)       (13.0)       ( 9.5)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                  PHENOLPHTHALEIN

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 735 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      370   370   404   439   515   559   594   605   606   606                 |
 |      648   650   659   683   687   700   702   709   723   724                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 12000   PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      435   549   571   628   673   674   675   679   679   705                 |
 |      717   718                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 25000   PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      391   503   568   601   608   616   622   624   647   661                 |
 |      689   690   697   711   717   726   729   730                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  PHENOLPHTHALEIN

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 735 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 50000   PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      271   330   434   484   491   506   512   581   622   697                 |
 |      712   724                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  PHENOLPHTHALEIN

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 735 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   735 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0 100.0  94.0  92.0  90.0  84.0  74.0  60.0      |
 |           |                                                                    |
 |           |                                                                    |
 |12000   PPM|   100.0 100.0 100.0 100.0 100.0  98.0  98.0  94.0  92.0  76.0      |
 |           |                                                                    |
 |           |                                                                    |
 |25000   PPM|   100.0 100.0 100.0 100.0  98.0  98.0  96.0  92.0  80.0  64.0      |
 |           |                                                                    |
 |           |                                                                    |
 |50000   PPM|   100.0 100.0 100.0  96.0  96.0  92.0  86.0  84.0  82.0  76.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        12000   PPM  25000   PPM  50000   P|M
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       60.0%        76.0%        64.0%        76.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.278N     P=0.108N     P=0.679N     P=0.166N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       597.7        641.9        640.6        530.3    |
 |NATURAL DEATHS (C)      |       (26.4)       (24.3)       (20.8)       (41.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       680.1        712.7        701.0        685.9    |
 |(STANDARD ERROR)        |       (14.2)       ( 8.0)       ( 9.8)       (15.8)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                          PHENOLPHTHALEIN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        12000   PPM      = 2
                                                        25000   PPM      = 3
                                                        50000   PPM      = 4

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

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

      |
      |
  100 + 1                                    1                     3             2   4
      |                                      1               1     3 3           2 2 4     4
      |                                                      1       3   13   3    2 1     42 4
      |                                                                       3     3       22
   90 +                                                                             31 1     22  4  3
      |                                                                                11     2 244 3 3
      |                                                                                 1  11   224 4 33  3
      |                                                                                     11   2 2
P  80 +                                                                                      1 1   2  2  4
E     |                                                                                        1 1       43 3
R     |                                                                                          111  2  244
C     |                                                                                            1   1   44
E  70 +                                                                                                  22 3 3
N     |                                                                                                11 224 33
T     |                                                                                                 11 22 43 3
      |                                                                                                  11    4 4
S  60 +                                                                                                   1  1   33
U     |                                                                                                     211
R     |                                                                                                      21  41 1
V     |                                                                                                       2   2 1  1
I  50 +                                                                                                           22   11
V     |                                                                                                            223  11
A     |                                                                                                            4223  11
L     |                                                                                                              223  1 1
   40 +                                                                                                               22
      |                                                                                                               422
      |                                                                                                                 222
      |                                                                                                                  33
   30 +                                                                                                                   2 2
      |
      |                                                                                                                  4  4
      |
   20 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 45 obs hidden.
                                                          PHENOLPHTHALEIN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        12000   PPM      = 2
                                                        25000   PPM      = 3
                                                        50000   PPM      = 4

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

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

      |
      |
  100 + 1                                          4              1   3      2
      |
      |                                            4         4        3      2         3       2
      |                                                      4    1     1   4          3       2  2
   95 +
      |                                                                 1   41       4            2    3   2
      |                                                                      1       44  1             33  2       2
      |
P  90 +                                                                               4 41      1       33
E     |
R     |                                                                                 44      1     1  33
C     |                                                                                  4         4  1 1 33
E  85 +
N     |                                                                                            4      43  3
T     |                                                                                                   4   3  3 2  42
      |
S  80 +                                                                                                 1     1  3   34242
U     |
R     |                                                                                                                 4 4
V     |                                                                                                       1  1   33  24 2
I  75 +
V     |                                                                                                          1  1 3 3
A     |                                                                                                             11  33
L     |
   70 +                                                                                                              11  33
      |
      |                                                                                                               11  3 3
      |                                                                                                                11
   65 +
      |                                                                                                                 1 1 3
      |
      |
   60 +                                                                                                                   1 1
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 6 obs hidden.