National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/1905

TDMS Study 05108-01 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Mason                                                     DATE: 09/13/94   
EXP: 05108                PROMETHAZINE HYDROCHLORIDE           TIME: 21:50:37   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: C60673   
CONT: NO1-ES-45069                                             CAS: 58-33-3     
PATHOLOGIST: R. FLEISCHMAN                   K. MURTHY                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Mason                                                     DATE: 09/13/94  
EXP: 05108                PROMETHAZINE HYDROCHLORIDE           TIME: 21:50:37  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: C60673  
CONT: NO1-ES-45069                                             CAS: 58-33-3    
PATHOLOGIST: R. FLEISCHMAN                   K. MURTHY                         

                            PROMETHAZINE HYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 717 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = VEHICLE                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 27     CENSORED DEATHS 10   TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      170   512   561   570   582   584   595   602   610   612                 |
 |      632   641   660   671   671   673   684   686   686   686                 |
 |      686   687   691   697   697   703   716                                   |
 |  CENSORED DEATHS                                                               |
 |      462   462   462   462   462   463   463   463   463   463                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 8.3     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 32     CENSORED DEATHS 10   TERMINAL 18        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      184   192   259   491   497   501   525   525   529   555                 |
 |      563   568   568   570   578   589   589   612   623   641                 |
 |      647   654   655   656   658   675   675   681   696   700                 |
 |      704   716                                                                 |
 |  CENSORED DEATHS                                                               |
 |      462   462   462   462   463   463   463   463   463   463                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 16.6    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 39     CENSORED DEATHS 10   TERMINAL 11        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      184   401   479   520   522   532   536   550   555   570                 |
 |      571   575   582   597   598   599   616   616   625   626                 |
 |      639   642   647   656   665   665   666   666   673   673                 |
 |      691   694   697   700   700   701   702   704   715                       |
 |  CENSORED DEATHS                                                               |
 |      462   462   462   462   462   463   463   463   463   463                 |
 |                                                                                |
 ==================================================================================

                            PROMETHAZINE HYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 717 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 33.3    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 41     CENSORED DEATHS 9    TERMINAL 10        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      49    53    138   288   289   365   458   541   555   562                 |
 |      565   568   576   583   584   592   592   602   604   608                 |
 |      612   617   620   624   624   624   625   632   639   656                 |
 |      657   658   658   666   667   667   675   680   693   708                 |
 |      715                                                                       |
 |  CENSORED DEATHS                                                               |
 |      462   462   462   462   462   462   463   463   463                       |
 |                                                                                |
 ==================================================================================

                            PROMETHAZINE HYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 717 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   717 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0  98.3  98.3  98.3  98.3  98.3  96.3  84.3  74.3  46.2      |
 |           |                                                                    |
 |           |                                                                    |
 |8.3        |   100.0 100.0  95.0  95.0  95.0  95.0  82.9  66.7  50.5  36.4      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |16.6       |   100.0 100.0  98.3  98.3  96.7  94.7  86.6  68.5  48.3  22.2      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |33.3       |    96.7  95.0  95.0  90.0  90.0  88.3  86.3  64.2  36.1  20.1      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      8.3          16.6         33.3     |
 |                                             MG/KG        MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       46.2%        36.4%        22.2%        20.1%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.153      P=0.009      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       628.3        571.1        609.0        558.3    |
 |NATURAL DEATHS (C)      |       (20.4)       (23.8)       (16.1)       (25.9)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       634.7        596.8        604.4        570.3    |
 |(STANDARD ERROR)        |       (14.5)       (17.0)       (14.3)       (20.1)   |
 |                        |                                                       |
 ==================================================================================
                                    


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

                            PROMETHAZINE HYDROCHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = VEHICLE                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 17     CENSORED DEATHS 11   TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      412   413   462   473   477   513   546   547   574   629                 |
 |      636   645   673   674   684   717   722                                   |
 |  CENSORED DEATHS                                                               |
 |      23    450   450   450   450   450   450   450   451   451                 |
 |      451                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 8.3     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 16     CENSORED DEATHS 10   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      479   566   591   597   597   597   616   624   632   632                 |
 |      639   657   676   692   704   717                                         |
 |  CENSORED DEATHS                                                               |
 |      450   450   450   450   450   451   451   451   451   451                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 16.6    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 19     CENSORED DEATHS 10   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      306   360   457   475   479   547   550   550   576   604                 |
 |      614   643   644   652   666   675   685   686   689                       |
 |  CENSORED DEATHS                                                               |
 |      450   450   450   450   451   451   451   451   451   451                 |
 |                                                                                |
 ==================================================================================

                            PROMETHAZINE HYDROCHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 33.3    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 27     CENSORED DEATHS 9    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      83    259   259   311   311   371   393   393   421   441                 |
 |      442   470   499   550   550   552   562   575   587   590                 |
 |      591   629   640   651   666   689   702                                   |
 |  CENSORED DEATHS                                                               |
 |      29    30    450   450   450   450   451   451   451                       |
 |                                                                                |
 ==================================================================================

                            PROMETHAZINE HYDROCHLORIDE


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


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0  96.6  90.4  88.4  82.2  76.1  65.8      |
 |           |                                                                    |
 |           |                                                                    |
 |8.3        |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  88.0  76.0  68.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |16.6       |   100.0 100.0 100.0  96.7  96.7  90.6  90.6  80.6  72.5  62.4      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |33.3       |    98.3  98.3  94.8  91.4  84.5  79.0  77.0  60.8  54.7  48.6      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      8.3          16.6         33.3     |
 |                                             MG/KG        MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       65.8%        68.0%        62.4%        48.6%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.009      P=0.808N     P=0.880      P=0.047  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       576.3        626.0        571.5        488.4    |
 |NATURAL DEATHS (C)      |       (25.4)       (14.6)       (25.8)       (29.6)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       627.5        655.1        632.7        564.9    |
 |(STANDARD ERROR)        |       (18.6)       (13.8)       (16.1)       (24.3)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                     PROMETHAZINE HYDROCHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE          = 1
                                                        8.3     MG/KG    = 2
                                                        16.6    MG/KG    = 3
                                                        33.3    MG/KG    = 4

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

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

      |
      |
  100 + 1       4                   1 2
      |         44            4     1 22         2                      3           3    1       1
      |                       4                  2    4                             3 2    3     11
      |                                               4           4                               1 1
   90 +                                                           4              4    22   23
      |                                                                          4          33434   1 11
      |                                                                                    22  334     1 1
      |                                                                                     2   2 3
P  80 +                                                                                         222      1  1
E     |                                                                                           333       11   1
R     |                                                                                             3  3         11
C     |                                                                                           224 4
E  70 +                                                                                            2  2           11
N     |                                                                                               2342         11
T     |                                                                                                  223
      |                                                                                                 442  2
S  60 +                                                                                                  443 22
U     |                                                                                                      322    11
R     |                                                                                                   44  33     11
V     |                                                                                                        3 3
I  50 +                                                                                                        2   2  11
V     |                                                                                                    44    3322  1 1
A     |                                                                                                     44 4  332 2  1
L     |
   40 +                                                                                                            3 322
      |                                                                                                              332 2
      |                                                                                                        4  4
      |
   30 +                                                                                                           44  33
      |                                                                                                            44
      |                                                                                                             44 343
      |                                                                                                                 43
   20 +                                                                                                                  4
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 36 obs hidden.

                                                     PROMETHAZINE HYDROCHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE          = 1
                                                        8.3     MG/KG    = 2
                                                        16.6    MG/KG    = 3
                                                        33.3    MG/KG    = 4

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

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

         |
         |
  105.34 +
         |
         |
         |1            4                           4      3        3       1          2
   97.24 +                                                         3       1       1  2            2
         |                                         4        4                      1 1             2    2
P        |                                                                           11                 22
E        |                                                  4       4                 1    1     3
R  89.14 +                                                          4    4                 1    1
C        |                                                               4   4                  11       2 2
E        |                                                                   4 4                 1  13     2 2
N        |                                                                     44                   13    3  12
T  81.03 +                                                                      4    4                    33 11
         |                                                                           4   4                 3  1212
S        |                                                                               4       4              12   1
U        |                                                                                                     3 3   2 2
R  72.93 +                                                                                                       3  3112 2
V        |                                                                                       4 4                33   2 2
I        |                                                                                         4 4               31    1  2
V        |                                                                                           44                    11
A  64.83 +                                                                                            4 4             33    1 1
L        |                                                                                                             3      3
         |                                                                                              4    4
         |                                                                                                   4 4
   56.72 +                                                                                                     44
         |                                                                                                      4   4
         |                                                                                                          4  4
         |                                                                                                             4 4
   48.62 +                                                                                                               4    4
         |
         -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
          0         10         20         30         40         50         60         70         80         90         100       110

                                                                     WEEK

NOTE: 19 obs hidden.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.