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TDMS Study 05182-04 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: TSI Mason Research                                     PHENOLPHTHALEIN                                    DATE: 04/04/96       
EXPERIMENT: 05182 TEST: 04                                                                                     TIME: 04:07:46       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-05302                              ROUTE: DOSED FEED                                              NTP C#: 55798B       
PATHOLOGIST: A. RUSSFIELD                                                                                      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: 04                                                                                     TIME: 04:07:46      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-05302                              ROUTE: DOSED FEED                                              NTP C#: 55798B      
PATHOLOGIST: A. RUSSFIELD                                                                                      CAS: 77-09-8        
                                  PHENOLPHTHALEIN

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      232   533   550   582   599   613   662   673   724   727                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 3000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      347   549   560   563   583   597   602   634   637   658                 |
 |      676   703   707   708   714   721   724                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 6000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      423   495   500   515   535   556   657   659   665   673                 |
 |      696   700   713   716                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  PHENOLPHTHALEIN

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 12000   PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 1    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      3     522   549   585   639   645   646   652   699   703                 |
 |      714   720   723                                                           |
 |  CENSORED DEATHS                                                               |
 |      28                                                                        |
 |                                                                                |
 ==================================================================================
                                  PHENOLPHTHALEIN

                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0  98.0  98.0  98.0  98.0  96.0  90.0  86.0  80.0      |
 |           |                                                                    |
 |           |                                                                    |
 |3000 PPM   |   100.0 100.0 100.0  98.0  98.0  98.0  98.0  86.0  80.0  66.0      |
 |           |                                                                    |
 |           |                                                                    |
 |6000 PPM   |   100.0 100.0 100.0 100.0  98.0  98.0  90.0  88.0  82.0  72.0      |
 |           |                                                                    |
 |           |                                                                    |
 |12000   PPM|    98.0  98.0  98.0  98.0  98.0  98.0  96.0  91.9  83.7  73.5      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        3000 PPM     6000 PPM     12000   P|M
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       80.0%        66.0%        72.0%        73.5%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.826      P=0.186      P=0.461      P=0.600  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       589.5        628.4        607.4        600.0    |
 |NATURAL DEATHS (C)      |       (45.0)       (23.1)       (26.4)       (52.9)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       701.1        694.8        694.9        681.4    |
 |(STANDARD ERROR)        |       (11.7)       (10.3)       (10.6)       (20.5)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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 MICE
                       FIRST TERMINAL SACRIFICE AT 737 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      78    156   546   597   613   615   628   686   708   723                 |
 |      730                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 3000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      126   266   435   450   500   511   550   570   578   581                 |
 |      581   608   615   643   659   663   668   703   708                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 6000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      329   338   479   551   561   567   602   604   615   622                 |
 |      645   651   654   686   686   693                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  PHENOLPHTHALEIN

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 737 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 12000   PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      40    447   449   450   505   514   568   573   578   588                 |
 |      589   594   598   601   602   640   652   667   680   715                 |
 |      722   730                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  PHENOLPHTHALEIN

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 737 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   737 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |    98.0  96.0  96.0  96.0  96.0  96.0  96.0  92.0  86.0  78.0      |
 |           |                                                                    |
 |           |                                                                    |
 |3000 PPM   |   100.0  98.0  96.0  96.0  96.0  92.0  88.0  78.0  68.0  62.0      |
 |           |                                                                    |
 |           |                                                                    |
 |6000 PPM   |   100.0 100.0 100.0  96.0  96.0  94.0  94.0  84.0  74.0  68.0      |
 |           |                                                                    |
 |           |                                                                    |
 |12000   PPM|    98.0  98.0  98.0  98.0  98.0  92.0  88.0  70.0  66.0  56.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        3000 PPM     6000 PPM     12000   P|M
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       78.0%        62.0%        68.0%        56.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.047      P=0.097      P=0.331      P=0.024  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       552.7        548.2        580.2        568.3    |
 |NATURAL DEATHS (C)      |       (67.4)       (33.9)       (27.9)       (30.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       696.5        665.2        686.8        662.8    |
 |(STANDARD ERROR)        |       (18.0)       (18.2)       (13.6)       (18.0)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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
                                                        3000 PPM         = 2
                                                        6000 PPM         = 3
                                                        12000   PPM      = 4

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

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

      |
      |
  100 + 14                                   1                 2           3
      |
      |  4                                   1                 2           3          3    4 1 2
      |                                                                               33   4 1 12
   95 +
      |                                                                                3 3     122  1
P     |                                                                                  3   3   2  1  1     4
E     |
R  90 +                                                                                      3  3   2  1 1   44
C     |
E     |                                                                                         3        1     3 1
N     |                                                                                                2    2 43 1 1
T  85 +
      |                                                                                                        4   1  4   1
S     |                                                                                                     2  2 3 3
U     |                                                                                                               44
R  80 +                                                                                                        2   2  344 1 1
V     |
I     |                                                                                                            2   244
V     |                                                                                                               3 3
A  75 +                                                                                                                  44
L     |                                                                                                                2234 4
      |                                                                                                                  3  3
      |
   70 +                                                                                                                 22
      |
      |                                                                                                                  22
      |                                                                                                                   2 2
   65 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 14 obs hidden.
                                                          PHENOLPHTHALEIN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        3000 PPM         = 2
                                                        6000 PPM         = 3
                                                        12000   PPM      = 4

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

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

      |
      |
  104 +
      |
      | 1      4     1      2                               3
      |        4     1      2    1                2         3 3               4
P  96 +                          1                2           3              24 4   3         1
E     |                                                                      2  2   3         13       1
R     |                                                                         2      24      3 3     1 1
C     |                                                                                224
E  88 +                                                                                 24     2 34    3 1 1
N     |                                                                                        2  2    33  1        1
T     |                                                                                           22    33          1   1
      |                                                                                            44    33             1 1
S  80 +                                                                                             4 4   3   3           1 1
U     |                                                                                            2    2                   11
R     |                                                                                               4422    33
V     |                                                                                                  2   2 3    3
I  72 +                                                                                                      2   2
V     |                                                                                                4     4      33
A     |                                                                                                      4 4 22  3       3
L     |                                                                                                        4  2    2
   64 +                                                                                                           4 4  22
      |                                                                                                             4   24   2
      |                                                                                                                  44
      |                                                                                                                   4 4
   56 +                                                                                                                     44
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.