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TDMS Study 05019-04 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 09/03/94   
EXP: 05019                     CI PIGMENT RED 3                TIME: 16:44:27   
TEST: 04              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60366    
CONT: NOIES9565102                                             CAS: 2425-85-6   
PATHOLOGIST: H. GILES                        S. EUSTIS                          
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REASONS FOR REMOVAL:                                                            
                                                                                
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REMOVAL DATE RANGE:                                                             


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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Southern Research Inst                                    DATE: 09/03/94  
EXP: 05019                     CI PIGMENT RED 3                TIME: 16:44:27  
TEST: 04              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60366   
CONT: NOIES9565102                                             CAS: 2425-85-6  
PATHOLOGIST: H. GILES                        S. EUSTIS                         

                                 CI PIGMENT RED 3


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 17     CENSORED DEATHS 10   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      151   240   291   324   416   450   489   583   599   630                 |
 |      653   680   681   681   697   700   724                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 10   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      56    180   228   283   295   316   322   336   388   402                 |
 |      484   512   576   588   648   650   653   653   679   703                 |
 |      704   710                                                                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 20     CENSORED DEATHS 9    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      85    221   279   295   372   430   469   521   541   553                 |
 |      556   570   642   658   662   697   697   703   704   724                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   457   457   457                       |
 |                                                                                |
 ==================================================================================

                                 CI PIGMENT RED 3


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 5.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 19     CENSORED DEATHS 8    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      84    210   231   280   289   294   301   323   325   326                 |
 |      454   555   557   557   557   557   567   578   665                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   457   457   457   457                             |
 |                                                                                |
 ==================================================================================

                                 CI PIGMENT RED 3


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0  98.3  96.7  93.3  91.7  90.0  88.0  83.9  79.8  67.5      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |1.25%      |    98.3  96.7  95.0  86.7  83.3  81.2  79.2  75.0  66.7  58.3      |
 |           |                                                                    |
 |           |                                                                    |
 |2.5%       |    98.3  98.3  96.7  93.3  91.7  88.0  84.0  78.0  72.0  62.0      |
 |           |                                                                    |
 |           |                                                                    |
 |5.0%       |    98.3  98.3  95.0  83.3  83.3  81.7  81.7  67.7  65.7  65.7      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATD     1.25%        2.5%         5.0%     |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       67.5%        58.3%        62.0%        65.7%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.817      P=0.330      P=0.684      P=0.662  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       528.8        471.2        519.0        405.8    |
 |NATURAL DEATHS (C)      |       (44.7)       (42.2)       (41.4)       (37.6)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       626.9        589.1        618.1        590.3    |
 |(STANDARD ERROR)        |       (19.5)       (22.9)       (20.3)       (23.2)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                 CI PIGMENT RED 3


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 11   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      326   508   528   630   653   680   691   703   719   724                 |
 |  CENSORED DEATHS                                                               |
 |      4     4     458   458   458   458   458   459   459   459                 |
 |      459                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 10   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      337   540   561   568   599   599   627   653   653   680                 |
 |      696   719   724                                                           |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 19     CENSORED DEATHS 10   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      474   497   542   547   568   595   597   606   613   616                 |
 |      627   670   676   679   696   696   709   724   724                       |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   459   459   459   459   459                 |
 |                                                                                |
 ==================================================================================

                                 CI PIGMENT RED 3


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 5.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 25     CENSORED DEATHS 10   TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      286   358   540   557   557   588   588   599   599   603                 |
 |      616   618   625   625   625   625   625   627   627   627                 |
 |      627   680   680   707   717                                               |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   459   459   459   459   459   459                 |
 |                                                                                |
 ==================================================================================

                                 CI PIGMENT RED 3


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0 100.0 100.0  98.3  98.3  98.3  94.2  94.2  90.1  79.8      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |1.25%      |   100.0 100.0 100.0  98.3  98.3  98.3  96.3  88.3  82.3  74.3      |
 |           |                                                                    |
 |           |                                                                    |
 |2.5%       |   100.0 100.0 100.0 100.0 100.0  98.0  94.0  86.0  78.0  62.0      |
 |           |                                                                    |
 |           |                                                                    |
 |5.0%       |   100.0 100.0 100.0  96.7  96.7  96.7  94.7  80.6  58.4  50.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATD     1.25%        2.5%         5.0%     |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       79.8%        74.3%        62.0%        50.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.637      P=0.078      P=0.002  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       616.2        612.0        624.0        597.0    |
 |NATURAL DEATHS (C)      |       (40.1)       (28.3)       (17.3)       (18.7)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       645.5        658.6        650.7        629.0    |
 |(STANDARD ERROR)        |       (21.0)       (14.4)       (13.8)       (14.8)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                          CI PIGMENT RED 3
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        1.25%            = 2
                                                        2.5%             = 3
                                                        5.0%             = 4

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

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

      |
      |
  100 + 1        2   43         1
      |          2   43         1    2   4 3   1
      |
      |                              2   4 32  1    3 1
   95 +                                     2       3213    1
      |                                             4242    1      3      1
      |
      |                                                2   2       3      1 3   1
   90 +                                               44                    3   1 3  1
      |                                                4   242
P     |                                                                           3  1     3        1
E     |                                                      2        2                    3  3     1  1
R  85 +                                                               2 2
C     |                                                     4           2       4    2        33       1   1
E     |                                                                                        33
N     |                                                                         4    2   2      4          1   1
T  80 +                                                                                         3 3            1    1
      |                                                                                  2         2
S     |                                                                                           322        3
U     |                                                                                                      3 3
R  75 +                                                                                             2         2
V     |                                                                                                        3 3  1 1
I     |                                                                                                          3    3
V     |                                                                                         44            22
A  70 +                                                                                          4 4                  1   1
L     |
      |                                                                                            4             4    33  1 1
      |                                                                                                        2 4 2        4
   65 +                                                                                                            2   2
      |                                                                                                                3  3
      |                                                                                                                   3 3
      |
   60 +                                                                                                                22
      |                                                                                                                 2   2
      |
      |
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 7 obs hidden.

                                                          CI PIGMENT RED 3
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        1.25%            = 2
                                                        2.5%             = 3
                                                        5.0%             = 4

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

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

      |
  100 + 1                                            4      1 2                    3
      |                                              4      1 2  4                      1     2
      |                                                                            3  3
      |                                                          4                    3 1   1 2  2
   95 +                                                                                       4 4
      |                                                                                     1 33 22        1
      |                                                                                        3  2    2   1   1
      |                                                                                         4   4
   90 +                                                                                           3   3        1    1
      |                                                                                                2   2
      |                                                                                               33            11
      |                                                                                             4  33  2   2     1 1
P  85 +
E     |                                                                                                 33             1 1
R     |                                                                                                44      2    2    11
C     |
E  80 +                                                                                                 43 3        2 2   1 1
N     |                                                                                                  44           2  2
T     |                                                                                                    3      3
      |                                                                                                   44      33     22
S  75 +
U     |                                                                                                                   2 2
R     |                                                                                                            3  3
V     |
I  70 +
V     |
A     |                                                                                                               3 3
L     |                                                                                                                 3 3
   65 +
      |
      |                                                                                                                   3 3
      |
   60 +
      |                                                                                                    4        4
      |
      |
   55 +                                                                                                             4  4
      |
      |                                                                                                                4 4
      |
   50 +                                                                                                                  4  4
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.

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