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TDMS Study 05706-01 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: IRDC                                                      DATE: 09/18/94   
EXP: 05706         4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID     TIME: 22:57:56   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60162    
CONT:                                                          CAS: 81-11-8     
PATHOLOGIST: M. STEDHAM                      S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: IRDC                                                      DATE: 09/18/94  
EXP: 05706         4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID     TIME: 22:57:56  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60162   
CONT:                                                          CAS: 81-11-8    
PATHOLOGIST: M. STEDHAM                      S. EUSTIS                         

                      4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 7      CENSORED DEATHS 10   TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      45    53    70    131   321   337   568                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 6250PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 9      CENSORED DEATHS 11   TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      209   279   439   605   607   628   696   711   714                       |
 |  CENSORED DEATHS                                                               |
 |      201   456   456   456   456   456   456   456   456   456                 |
 |      456                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 12500PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 8      CENSORED DEATHS 10   TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      22    22    65    130   131   438   576   645                             |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                      4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |    95.0  93.3  93.3  90.0  90.0  90.0  90.0  88.0  88.0  88.0      |
 |           |                                                                    |
 |           |                                                                    |
 |6250PPM    |   100.0 100.0  98.3  96.6  96.6  94.9  94.9  92.9  88.7  82.5      |
 |           |                                                                    |
 |           |                                                                    |
 |12500PPM   |    95.0  91.7  91.7  91.7  91.7  90.0  90.0  88.0  85.9  85.9      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                CONTROL          6250PPM          12500PPM      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       88.0%            82.5%            85.9%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.888          P=0.842          P=0.992       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       217.9            543.1            253.6         |
 |NATURAL DEATHS (C)      |       (74.6)           (63.3)           (91.1)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       623.9            646.8            620.1         |
 |(STANDARD ERROR)        |       (24.6)           (18.5)           (25.5)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                      4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 7      CENSORED DEATHS 10   TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      410   587   602   614   695   710   714                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 6250PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 7      CENSORED DEATHS 10   TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      163   438   558   601   639   662   676                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 12500PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 11     CENSORED DEATHS 11   TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      529   602   639   640   660   667   672   680   684   718                 |
 |      721                                                                       |
 |  CENSORED DEATHS                                                               |
 |      387   456   456   456   456   456   456   456   456   456                 |
 |      456                                                                       |
 |                                                                                |
 ==================================================================================

                      4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID


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


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0  98.3  98.3  98.3  94.3  92.3  86.3      |
 |           |                                                                    |
 |           |                                                                    |
 |6250PPM    |   100.0  98.3  98.3  98.3  98.3  96.7  96.7  92.6  88.6  86.6      |
 |           |                                                                    |
 |           |                                                                    |
 |12500PPM   |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  95.9  89.8  77.6      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                CONTROL          6250PPM          12500PPM      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       86.3%            86.6%            77.6%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.348          P=1.000          P=0.417       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       618.9            533.9            655.6         |
 |NATURAL DEATHS (C)      |       (40.3)           (68.9)           (16.4)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       670.7            660.7            664.4         |
 |(STANDARD ERROR)        |       (14.0)           (16.2)           (14.1)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                              4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        6250PPM          = 2
                                                        12500PPM         = 3

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

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

      |
      |
  100 + 1   3   1                        2
      |
      |
      |         11                       2          2
   98 +
      |
      |
      |     3    1 1                                2                        2
   96 +
      |
P     |            1         1                                               2                          2
E     |
R  94 +
C     |                      1                             1
E     |
N     |
T  92 +
      |                      3                             1  1              3
S     |                                                                                                 2  2
U     |
R  90 +                                                       1              3                    13
V     |
I     |
V     |                                                                                                    2          2
A  88 +                                                                                           13          3             1
L     |
      |
      |                                                                                                               2 2
   86 +                                                                                                       3             3
      |
      |
      |
   84 +
      |
      |
      |                                                                                                                 2   2
   82 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 5 obs hidden.

                                              4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        6250PPM          = 2
                                                        12500PPM         = 3

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

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

        |
        |
  100.0 +1                         2                                      1                  3
        |
        |
        |                          2                                      1   2              3       1  3
   97.5 +
        |                                                                     2                  2
        |                                                                                            1  1
        |                                                                                               3     3
   95.0 +
        |                                                                                        2      1 1
P       |
E       |
R  92.5 +                                                                                               2 1   2        1
C       |                                                                                                     3   3
E       |
N       |                                                                                                     2   2
T  90.0 +                                                                                                         33   1 1
        |
S       |                                                                                                         2 2
U       |
R  87.5 +
V       |                                                                                                           2        2
I       |                                                                                                                1   1
V       |                                                                                                          3 3
A  85.0 +
L       |
        |
        |
   82.5 +
        |                                                                                                            3    3
        |
        |
   80.0 +
        |
        |
        |
   77.5 +                                                                                                                 3  3
        |
        -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-
         0         10         20         30         40         50         60         70         80         90         100        110

                                                                    WEEK

NOTE: 3 obs hidden.