National Toxicology Program

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TDMS Study 05057-02 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Mason                                                     DATE: 09/08/94   
EXP: 05057                       HC YELLOW 4                   TIME: 06:34:19   
TEST: 02              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 56019    
CONT: N01ES9561901                                             CAS: 5982043-8   
PATHOLOGIST: R. FLEISCHMAN                   S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
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REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Mason                                                     DATE: 09/08/94  
EXP: 05057                       HC YELLOW 4                   TIME: 06:34:19  
TEST: 02              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 56019   
CONT: N01ES9561901                                             CAS: 5982043-8  
PATHOLOGIST: R. FLEISCHMAN                   S. EUSTIS                         

                                    HC YELLOW 4


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATED 61UM                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 22     CENSORED DEATHS 20   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      51    62    93    104   146   224   248   322   371   398                 |
 |      409   420   449   508   519   616   692   694   721   723                 |
 |      723   723                                                                 |
 |  CENSORED DEATHS                                                               |
 |      189   189   189   189   189   189   189   189   189   190                 |
 |      455   455   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5%    61                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 20     CENSORED DEATHS 21   TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      73    94    100   152   168   271   291   328   377   384                 |
 |      399   409   512   567   592   607   626   658   675   687                 |
 |  CENSORED DEATHS                                                               |
 |      189   189   189   189   189   189   189   189   190   190                 |
 |      273   455   455   455   455   456   456   456   456   456                 |
 |      456                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.O%    61                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 14     CENSORED DEATHS 21   TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      220   297   308   405   448   484   567   602   617   645                 |
 |      668   679   701   708                                                     |
 |  CENSORED DEATHS                                                               |
 |      189   189   189   190   190   190   190   190   190   190                 |
 |      394   455   455   455   455   455   455   455   455   455                 |
 |      456                                                                       |
 |                                                                                |
 ==================================================================================

                                    HC YELLOW 4


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATED  |    97.1  92.9  89.5  87.8  81.0  79.4  75.1  75.1  72.9  60.0      |
 |61UM       |                                                                    |
 |           |                                                                    |
 |0.5%    61 |    98.6  92.9  92.9  87.7  80.8  80.8  78.7  74.3  67.7  63.4      |
 |           |                                                                    |
 |           |                                                                    |
 |1.O%    61 |   100.0 100.0  98.3  95.0  93.3  89.5  89.5  85.4  81.2  72.9      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                UNTREATED        0.5%    61       1.O%    61    |
 |                                61UM                                            |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       60.0%            63.4%            72.9%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.119N         P=0.937N         P=0.133N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       418.9            398.5            524.9         |
 |NATURAL DEATHS (C)      |       (50.9)           (46.9)           (44.1)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       515.8            512.3            567.7         |
 |(STANDARD ERROR)        |       (28.0)           (27.3)           (24.4)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                    HC YELLOW 4


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATED 61UF                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 7      CENSORED DEATHS 20   TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      263   463   466   532   533   625   634                                   |
 |  CENSORED DEATHS                                                               |
 |      177   177   178   178   178   178   178   178   178   178                 |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5%    61                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 12     CENSORED DEATHS 20   TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      192   519   592   647   664   676   682   688   704   711                 |
 |      718   722                                                                 |
 |  CENSORED DEATHS                                                               |
 |      177   177   177   177   178   178   178   178   178   178                 |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.0%    61                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 7      CENSORED DEATHS 20   TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      554   561   578   610   613   647   729                                   |
 |  CENSORED DEATHS                                                               |
 |      177   177   177   177   178   178   178   178   178   178                 |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                                    HC YELLOW 4


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATED  |   100.0 100.0  98.3  98.3  98.3  94.3  90.3  90.3  86.3  86.3      |
 |61UF       |                                                                    |
 |           |                                                                    |
 |0.5%    61 |   100.0 100.0  98.3  98.3  98.3  98.3  96.3  94.3  90.3  76.3      |
 |           |                                                                    |
 |           |                                                                    |
 |1.0%    61 |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  94.0  88.0  86.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                UNTREATED        0.5%    61       1.0%    61    |
 |                                61UF                                            |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       86.3%            76.3%            86.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=1.000N         P=0.375          P=1.000N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       502.3            626.3            613.1         |
 |NATURAL DEATHS (C)      |       (47.4)           (42.9)           (22.9)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       589.2            594.2            600.3         |
 |(STANDARD ERROR)        |       (24.4)           (24.4)           (23.8)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                            HC YELLOW 4
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATED 61UM   = 1
                                                        0.5%    61       = 2
                                                        1.O%    61       = 3

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

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

      |
      |
  100 + 1        1  2                      3
      |          11 2  2                   3           3
      |           1    1 2
      |                1 1      2                      33
   95 +                                                 3               3
      |                  1     12 2                                     3     3
      |                        1  2        1       2
      |                                    1    1  2  2                       3      3
P  90 +                                         1     2    12                        3           3
E     |
R     |                                                    12     12                             3     3
C     |                                                           12 2 1
E  85 +                                                                1 1                             3  3
N     |                                                              2 2                                  3   3
T     |                                                                2 11
      |                                                                  21     1        2                    3   3
S  80 +
U     |                                                                         1       12       2                33
R     |                                                                                 1  1                       3   3
V     |                                                                                          2    2
I  75 +                                                                                    1             1             33
V     |                                                                                               2 2
A     |                                                                                                 21 2         1  3   3
L     |                                                                                                              11
   70 +                                                                                                    2   2
      |                                                                                                               1  1
      |                                                                                                        2   2
      |                                                                                                                  11
   65 +                                                                                                            2 2
      |                                                                                                              2      2
      |
      |
   60 +                                                                                                                   1 1
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 5 obs hidden.

                                                            HC YELLOW 4
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATED 61UF   = 1
                                                        0.5%    61       = 2
                                                        1.0%    61       = 3

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

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

         |
         |
  100.34 +1                              2          1                                             3
         |
         |                               2          1                               1        2    33
         |
P  96.33 +                                                                                   2     3 3  2
E        |
R        |                                                                          1         1      3  2  3    2
C        |
E  92.31 +                                                                                    11                2  2
N        |
T        |                                                                                     1           3 1  3  2 2
         |
S  88.30 +                                                                                                   11 3    22       3
U        |
R        |                                                                                                    1       22      1
V        |
I  84.29 +                                                                                                             2 2
V        |
A        |                                                                                                               22
L        |
   80.27 +                                                                                                                22
         |
         |                                                                                                                 22
         |
   76.26 +                                                                                                                  2 2
         |
         -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
          0         10         20         30         40         50         60         70         80         90         100       110

                                                                     WEEK

NOTE: 3 obs hidden.
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