National Toxicology Program

National Toxicology Program
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TDMS Study 05103-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                       2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL                         DATE: 05/19/95       
EXPERIMENT: 05103 TEST: 05                                                                                     TIME: 20:09:59       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85234                              ROUTE: DOSED FEED                                              NTP C#: 55516C       
PATHOLOGIST: DR. D. FARNELL                                                                                    CAS: 3296-90-0       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    


               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Southern Research Inst                       2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL                         DATE: 05/19/95      
EXPERIMENT: 05103 TEST: 05                                                                                     TIME: 20:09:59      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-85234                              ROUTE: DOSED FEED                                              NTP C#: 55516C      
PATHOLOGIST: DR. D. FARNELL                                                                                    CAS: 3296-90-0      

                       2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 25     CENSORED DEATHS 19   TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      334   467   481   519   608   619   619   628   629   631                 |
 |      659   660   663   675   675   675   682   696   697   703                 |
 |      716   721   722   725   726                                               |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    92    92    92    92    92                  |
 |      456   456   456   456   456   456   456   456   456                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 33     CENSORED DEATHS 7    TERMINAL 20        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      235   450   451   467   480   512   512   537   543   548                 |
 |      555   568   576   586   586   610   620   645   648   659                 |
 |      660   662   675   675   681   681   695   696   711   716                 |
 |      723   725   726                                                           |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456                                   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.50%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 38     CENSORED DEATHS 9    TERMINAL 13        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      451   536   536   564   576   592   605   608   608   620                 |
 |      621   621   627   633   641   641   641   645   654   656                 |
 |      662   666   666   673   681   684   684   689   694   695                 |
 |      696   696   697   697   703   722   726   731                             |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456                       |
 |                                                                                |
 ==================================================================================

                       2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1.00%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 54     CENSORED DEATHS 5    TERMINAL 1         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      149   381   393   432   451   471   495   509   513   516                 |
 |      523   541   542   544   549   556   567   567   567   568                 |
 |      570   570   574   576   576   577   585   586   598   604                 |
 |      608   610   619   619   619   620   620   643   647   654                 |
 |      658   662   662   670   681   682   687   690   695   697                 |
 |      709   711   723   733                                                     |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456                                               |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.00%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 60     CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      222   365   366   388   396   402   410   424   425   432                 |
 |      432   439   451   471   471   490   507   507   511   513                 |
 |      513   516   516   519   520   521   522   522   527   530                 |
 |      537   572   575   576   579   585   586   591   592   592                 |
 |      605   610   619   619   619   620   621   625   647   653                 |
 |      654   659   659   660   663   677   703   704   704   726                 |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    92    92    92    92    92                  |
 |                                                                                |
 ==================================================================================

                       2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 736 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   736 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0 100.0 100.0  98.3  98.3  94.4  92.4  92.4  74.7  51.1      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.25%      |   100.0 100.0  98.3  98.3  98.3  91.2  83.6  72.2  58.9  38.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.50%      |   100.0 100.0 100.0 100.0 100.0  98.3  94.4  86.5  59.0  25.6      |
 |           |                                                                    |
 |           |                                                                    |
 |1.00%      |   100.0  98.3  98.3  98.3  95.0  89.8  75.2  45.8  22.0   1.8      |
 |           |                                                                    |
 |           |                                                                    |
 |2.00%      |   100.0 100.0  98.3  96.7  85.0  75.0  48.3  31.7   8.3   0.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================

                       2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 736 DAYS


 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                           DOSE                                              |
 |                                                                                                                             |
 |                                UNTREATD           0.25%              0.50%              1.00%              2.00%            |
 |                                CONTROL                                                                                      |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       51.1%              38.0%              25.6%               1.8%               0.0%            |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P<0.001            P=0.124            P=0.010            P<0.001            P<0.001          |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       637.2              600.4              645.7              584.6              544.3            |
 |NATURAL DEATHS (C)      |       (19.0)             (18.7)             ( 9.6)             (13.8)             (13.3)           |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       572.7              628.8              636.8              576.4              479.7            |
 |(STANDARD ERROR)        |       (26.7)             (15.4)             (12.5)             (13.5)             (22.2)           |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    


       (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)

                       2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 738 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 14     CENSORED DEATHS 10   TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      460   481   516   624   633   654   689   690   694   696                 |
 |      696   708   716   722                                                     |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 24     CENSORED DEATHS 9    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      404   460   509   609   619   645   656   676   680   683                 |
 |      684   684   695   695   697   701   704   709   719   722                 |
 |      723   723   725   725                                                     |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.50%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 30     CENSORED DEATHS 7    TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      388   409   432   481   508   565   576   585   610   627                 |
 |      631   632   633   660   662   670   670   673   682   683                 |
 |      694   695   695   696   697   697   704   719   726   728                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456                                   |
 |                                                                                |
 ==================================================================================

                       2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 738 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1.00%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 47     CENSORED DEATHS 8    TERMINAL 5         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      369   432   460   474   509   516   523   540   551   574                 |
 |      577   585   585   592   592   594   598   610   610   619                 |
 |      625   625   627   630   631   631   634   645   659   660                 |
 |      660   670   680   682   682   683   683   684   684   689                 |
 |      694   694   709   722   725   725   726                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456                             |
 |                                                                                |
 ==================================================================================

                       2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 738 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   738 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0 100.0 100.0 100.0 100.0  96.0  94.0  94.0  88.0  72.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.25%      |   100.0 100.0 100.0 100.0  98.3  96.4  94.4  94.4  86.5  53.1      |
 |           |                                                                    |
 |           |                                                                    |
 |0.50%      |   100.0 100.0 100.0 100.0  96.7  93.1  91.2  85.5  72.2  43.7      |
 |           |                                                                    |
 |           |                                                                    |
 |1.00%      |   100.0 100.0 100.0 100.0  98.3  92.8  85.1  67.7  40.6   9.7      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATD     0.25%        0.50%        1.00%    |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       72.0%        53.1%        43.7%         9.7%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.095      P=0.004      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       641.4        660.3        627.6        618.5    |
 |NATURAL DEATHS (C)      |       (24.0)       (17.5)       (17.4)       (11.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       668.5        664.6        649.9        606.8    |
 |(STANDARD ERROR)        |       (14.5)       (14.1)       (14.3)       (12.8)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        0.25%            = 2
                                                        0.50%            = 3
                                                        1.00%            = 4
                                                        2.00%            = 5

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

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

      |
  100 + 1                       4          5 2               1                  3
      |                         4          5 2               1    5  4 4        2 1 1        3
      |                                                           5   54    4   2 2 1      1 3   3
      |                                                               555   4   4 242      1     3 3    1
   90 +                                                                 55         42 4  2         3  3 1 1
      |                                                                  5 5          4 42   2        3 3 11
      |                                                                    55           44   22
      |                                                                     55           4 4  222       3 311
   80 +                                                                      5  5          4  4 2 2         1    1
      |                                                                         5  5              22      33
      |                                                                            5 5        44   22      33    1 1
      |                                                                              5  5      444  2    2  33
P  70 +                                                                                                  22        11
E     |                                                                                 55                2  32     1 1
R     |                                                                                          44           23 2
C     |                                                                                  5 5                          11
E  60 +                                                                                                        3 232   1 1
N     |                                                                                           44                     11
T     |                                                                                                           322
      |                                                                                    55      44              32 2
S  50 +                                                                                     55      4  4                  1  1
U     |                                                                                      5    55   44           332 2
R     |                                                                                                 44           33 22
V     |                                                                                            55    44              22
I  40 +
V     |                                                                                             5 5                   2  2
A     |
L     |                                                                                               5 554  4        33  3
   30 +                                                                                                  55  444
      |                                                                                                                   3 3
      |                                                                                                        4 4          33
      |                                                                                                   55     44
   20 +                                                                                                    5  5   4 4
      |                                                                                                       55    44
      |                                                                                                        5 5
      |                                                                                                              44
   10 +                                                                                                               4 4
      |                                                                                                          5 5   5
      |                                                                                                                 4 4
      |                                                                                                                5  4 44
    0 +                                                                                                                   5
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 24 obs hidden.

                                                2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        0.25%            = 2
                                                        0.50%            = 3
                                                        1.00%            = 4

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

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

      |
      |
  100 + 1                                                         4   3 2        1
      |                                                           4   3 23  3    1  1   2
      |                                                                     3    4 41   21              2  1
      |                                                                            43   3               2 211
   90 +                                                                                 34 4     3 3      2 1 21
      |                                                                                    4  4    33         21   2 1
      |                                                                                       44    3    3         2211
      |                                                                                        4  4      3 33
   80 +                                                                                           444
      |                                                                                                             2 1 1
P     |                                                                                             4 4     3    3      111
E     |                                                                                                          33       1  1
R  70 +                                                                                               44              22
C     |                                                                                                4 4        333  22
E     |                                                                                                  44             22
N     |                                                                                                   44        3 3  22
T  60 +
      |
S     |                                                                                                    44
U     |                                                                                                               33  2  2
R  50 +                                                                                                                3 3
V     |                                                                                                     4 4  4       33
I     |
V     |                                                                                                                   3  3
A  40 +                                                                                                          44
L     |                                                                                                           4 4
      |
      |
   30 +
      |
      |                                                                                                             44
      |                                                                                                              44
   20 +                                                                                                               4 4
      |                                                                                                                 4 4
      |
      |
   10 +                                                                                                                   4  4
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 23 obs hidden.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.