National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/1893

TDMS Study 05108-02 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Mason                                                     DATE: 09/14/94   
EXP: 05108                PROMETHAZINE HYDROCHLORIDE           TIME: 00:32:16   
TEST: 02              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: 09/14/94  
EXP: 05108                PROMETHAZINE HYDROCHLORIDE           TIME: 00:32:16  
TEST: 02              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 MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = VEHICLE                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 11     CENSORED DEATHS 10   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      283   362   516   580   584   627   633   674   676   698                 |
 |      722                                                                       |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   460   460   460   460                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 11.25   MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 6      CENSORED DEATHS 10   TERMINAL 44        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      128   211   568   600   649   713                                         |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   460   460   460   460                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 22.5    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 10   TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      444   453   522   526   527   528   666   693   710   725                 |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   460   460   460   460   460   460                 |
 |                                                                                |
 ==================================================================================

                            PROMETHAZINE HYDROCHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 45.0    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 6      CENSORED DEATHS 10   TERMINAL 44        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      568   631   669   696   703   713                                         |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   460   460   460   460   460   460                 |
 |                                                                                |
 ==================================================================================

                            PROMETHAZINE HYDROCHLORIDE


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


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0  96.7  96.7  96.7  94.7  90.6  86.6  78.5      |
 |           |                                                                    |
 |           |                                                                    |
 |11.25      |   100.0  98.3  96.7  96.7  96.7  96.7  96.7  92.6  90.6  88.6      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |22.5       |   100.0 100.0 100.0 100.0 100.0  96.7  88.6  88.6  88.6  80.6      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |45.0       |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0  96.0  88.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      11.25        22.5         45.0     |
 |                                             MG/KG        MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       78.5%        88.6%        80.6%        88.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.353N     P=0.298N     P=0.988N     P=0.253N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       577.7        478.2        579.4        663.3    |
 |NATURAL DEATHS (C)      |       (42.3)       ( 100)       (34.1)       (22.6)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       656.2        658.9        659.1        677.5    |
 |(STANDARD ERROR)        |       (15.6)       (17.7)       (14.7)       (13.1)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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 MICE
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = VEHICLE                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 11     CENSORED DEATHS 10   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      442   529   582   601   622   693   707   715   718   720                 |
 |      728                                                                       |
 |  CENSORED DEATHS                                                               |
 |      462   462   462   462   462   462   462   464   464   464                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 3.75    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 8      CENSORED DEATHS 10   TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      554   677   693   694   710   722   725   732                             |
 |  CENSORED DEATHS                                                               |
 |      462   462   462   462   464   464   464   464   464   464                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 7.5     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 11   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      388   569   626   629   632   640   701   707   731   732                 |
 |  CENSORED DEATHS                                                               |
 |      371   462   462   462   462   464   464   464   464   464                 |
 |      723                                                                       |
 |                                                                                |
 ==================================================================================

                            PROMETHAZINE HYDROCHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 15.0    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 9      CENSORED DEATHS 10   TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      66    517   554   561   643   650   679   722   734                       |
 |  CENSORED DEATHS                                                               |
 |      6     462   462   462   462   464   464   464   464   464                 |
 |                                                                                |
 ==================================================================================

                            PROMETHAZINE HYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE 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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0  98.3  96.3  92.3  90.3  78.3      |
 |           |                                                                    |
 |           |                                                                    |
 |3.75       |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0  98.0  84.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |7.5        |   100.0 100.0 100.0 100.0  98.3  98.3  98.3  96.3  88.3  80.2      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |15.0       |    98.3  98.3  98.3  98.3  98.3  98.3  96.3  92.3  88.3  82.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      3.75         7.5          15.0     |
 |                                             MG/KG        MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       78.3%        84.0%        80.2%        82.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.893N     P=0.553N     P=0.983N     P=0.819N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       641.5        688.4        635.5        569.6    |
 |NATURAL DEATHS (C)      |       (28.6)       (20.3)       (32.3)       (67.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       673.1        684.2        672.0        657.9    |
 |(STANDARD ERROR)        |       (14.0)       (13.3)       (14.6)       (20.0)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                     PROMETHAZINE HYDROCHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE          = 1
                                                        11.25   MG/KG    = 2
                                                        22.5    MG/KG    = 3
                                                        45.0    MG/KG    = 4

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

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

         |
         |
  100.69 +
         |1                    2                       1                        3                   4
         |                     2            2          1           1            3 3
         |                                                                                          4         4
P  96.67 +                                  2                      1              3        1 3      2
E        |                                                                                                    4     4
R        |                                                                                 1 33     21   2
C        |                                                                                                          4   4
E  92.64 +                                                                                           11  2      2
N        |                                                                                                              44
T        |                                                                                            1      1  2         2
         |                                                                                                               44
S  88.61 +                                                                                    3              11     3     2   2
U        |                                                                                                                4   4
R        |                                                                                                    1     31 3
V        |
I  84.58 +                                                                                                             3  3
V        |
A        |                                                                                                           1  1 3 3
L        |
   80.56 +                                                                                                              1   1 3
         |
         |                                                                                                                  1 1
         |
   76.53 +
         |
         -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
          0         10         20         30         40         50         60         70         80         90         100       110

                                                                     WEEK

NOTE: 4 obs hidden.

                                                     PROMETHAZINE HYDROCHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE          = 1
                                                        3.75    MG/KG    = 2
                                                        7.5     MG/KG    = 3
                                                        15.0    MG/KG    = 4

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

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

        |
        |
  100.0 +1          4                                                  3       1                 2
        |
        |
        |           4                                                  3       1          4  1   2 3                2
   97.5 +
        |
        |                                                                                 4  1   4 3 1      3       2 2
        |
   95.0 +
        |                                                                                        44  1  1
P       |                                                                                                             22
E       |
R  92.5 +                                                                                         4     1  1334
C       |                                                                                                              2 2
E       |
N       |
T  90.0 +                                                                                                  1 334      1  2 2
        |
S       |
U       |                                                                                                     34    4 1 1
R  87.5 +
V       |
I       |                                                                                                           4   1 12 2
V       |
A  85.0 +
L       |                                                                                                               3  4 3
        |                                                                                                                    22
        |
   82.5 +                                                                                                                    44
        |
        |
        |
   80.0 +                                                                                                                 11 33
        |
        |
        |                                                                                                                  1  1
   77.5 +
        |
        -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-
         0         10         20         30         40         50         60         70         80         90         100        110

                                                                    WEEK

NOTE: 7 obs hidden.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.