National Toxicology Program

National Toxicology Program
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TDMS Study 05103-04 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: 04                                                                                     TIME: 19:23:26       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85234                              ROUTE: DOSED FEED                                              NTP C#: 55516C       
PATHOLOGIST: DR J. HEATH                     LEININGER, JOEL                                                   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: 04                                                                                     TIME: 19:23:26      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-85234                              ROUTE: DOSED FEED                                              NTP C#: 55516C      
PATHOLOGIST: DR J. HEATH                     LEININGER, JOEL                                                   CAS: 3296-90-0      

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


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 8      CENSORED DEATHS 10   TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      310   478   579   606   614   639   674   705                             |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.0312%                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 15     CENSORED DEATHS 9    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      17    19    362   461   543   586   592   625   625   646                 |
 |      656   678   683   705   731                                               |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.0625%                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 15     CENSORED DEATHS 10   TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      45    536   572   579   626   662   666   668   669   669                 |
 |      669   669   677   687   731                                               |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

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


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.125%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 18     CENSORED DEATHS 12   TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      248   447   515   565   589   592   592   593   641   656                 |
 |      669   669   669   669   703   705   725   725                             |
 |  CENSORED DEATHS                                                               |
 |      445   456   456   456   456   456   456   456   456   456                 |
 |      456   690                                                                 |
 |                                                                                |
 ==================================================================================

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       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  96.3  96.3  94.3  88.3  84.3      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.0312%    |    96.7  96.7  96.7  95.0  95.0  93.0  91.0  87.1  79.2  71.3      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0625%    |    98.3  98.3  98.3  98.3  98.3  98.3  96.3  92.3  88.3  70.2      |
 |           |                                                                    |
 |           |                                                                    |
 |0.125%     |   100.0 100.0  98.3  98.3  98.3  96.6  94.6  84.3  80.2  63.5      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATD     0.0312%      0.0625%      0.125%   |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       84.3%        71.3%        70.2%        63.5%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.054      P=0.167      P=0.174      P=0.038  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       575.6        528.6        608.3        609.6    |
 |NATURAL DEATHS (C)      |       (44.9)       (58.9)       (42.3)       (27.5)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       668.0        642.2        657.4        645.8    |
 |(STANDARD ERROR)        |       (15.3)       (20.9)       (17.1)       (16.0)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 743 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 15     CENSORED DEATHS 8    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      285   407   447   484   499   569   571   618   624   631                 |
 |      631   640   646   648   705                                               |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456                             |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.0312%                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 20     CENSORED DEATHS 10   TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      1     386   513   579   606   606   608   619   625   627                 |
 |      635   655   668   669   670   677   677   692   696   730                 |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.0625%                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 25     CENSORED DEATHS 9    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      397   428   536   543   557   575   605   620   629   639                 |
 |      639   652   669   669   669   679   683   693   707   709                 |
 |      711   718   719   726   733                                               |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457                       |
 |                                                                                |
 ==================================================================================

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 743 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.125%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 39     CENSORED DEATHS 10   TERMINAL 11        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      401   449   456   480   483   490   502   520   526   534                 |
 |      534   537   537   551   551   554   575   576   586   606                 |
 |      610   615   642   649   649   656   667   668   669   669                 |
 |      669   669   669   669   672   674   677   719   733                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 743 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   743 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0 100.0 100.0  98.3  96.7  93.1  91.1  87.2  73.7  71.7      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.0312%    |    98.3  98.3  98.3  98.3  96.7  96.7  94.7  92.6  76.5  60.4      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0625%    |   100.0 100.0 100.0 100.0  98.3  96.7  92.7  86.8  76.9  51.3      |
 |           |                                                                    |
 |           |                                                                    |
 |0.125%     |   100.0 100.0 100.0 100.0  98.3  91.0  74.8  62.7  48.5  22.2      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATD     0.0312%      0.0625%      0.125%   |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       71.7%        60.4%        51.3%        22.2%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.432      P=0.119      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       560.3        597.0        636.2        592.1    |
 |NATURAL DEATHS (C)      |       (29.4)       (35.5)       (17.7)       (13.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       659.1        646.7        655.6        597.1    |
 |(STANDARD ERROR)        |       (16.1)       (18.2)       (14.6)       (14.0)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)

                                                2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        0.0312%          = 2
                                                        0.0625%          = 3
                                                        0.125%           = 4

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

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

      |
      |
  100 + 1  2    3                               4         1
      |         3                               4         1                   4     1        3
      |
      |    2                                                     2            4     1    4   3    31
   95 +                                                          2               2       4       4
      |                                                                                           31    1
      |                                                                          2            2  4 3  4 11 3
      |                                                                                       2     2
P  90 +                                                                                                  1 3 1   3
E     |                                                                                             2 2      1   331
R     |                                                                                               2    2
C     |                                                                                                            1   1
E  85 +
N     |                                                                                               4    2 42        1     1
T     |                                                                                                      4 4
      |                                                                                                       22
S  80 +                                                                                                        4  4
U     |                                                                                                        2   2
R     |                                                                                                            22
V     |                                                                                                           33
I  75 +                                                                                                             2  2
V     |                                                                                                            3 3 2    2
A     |                                                                                                           4  3 4    3
L     |                                                                                                                     22
   70 +                                                                                                                     33
      |
      |                                                                                                                4  4
      |
   65 +
      |                                                                                                                   4  4
      |
      |
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 4 obs hidden.

                                                2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        0.0312%          = 2
                                                        0.0625%          = 3
                                                        0.125%           = 4

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

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

      |
      |
  100 + 12                                           1                 34
      |  2                                           1                2341  3 1 44       2   3
      |                                                                       1  4  41   2   33    2
      |                                                                              1 1      3 3  2    2
   90 +                                                                             44 1        3 13    3
      |                                                                                4   4      1     2 1
      |                                                                                    44             11
      |                                                                                     44             113
P  80 +                                                                                                    211 3
E     |                                                                                                     2112  2
R     |                                                                                      4 4
C     |                                                                                                       1        1      1
E  70 +                                                                                        44                 223
N     |                                                                                         4  4               232
T     |                                                                                            44                223
      |                                                                                             4   4             233   2
S  60 +                                                                                                 44              33  2 2
U     |                                                                                                  4   4
R     |                                                                                                      44          33
V     |                                                                                                                   3 3 3
I  50 +                                                                                                       44
V     |                                                                                                        4  4
A     |
L     |
   40 +
      |
      |
      |
   30 +                                                                                                           44
      |                                                                                                            4     4
      |                                                                                                                  4  4
      |                                                                                                                     4 4
   20 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 30 obs hidden.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.