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TDMS Study 05214-01 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Mason                                         TRANS-DELTA-9-TETRAHYDROCANNABINOL                          DATE: 05/20/95       
EXPERIMENT: 05214 TEST: 01                                                                                     TIME: 12:27:42       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85212                              ROUTE: GAVAGE                                                  NTP C#: 56371B       
PATHOLOGIST: K. MURTHY                                                                                         CAS: 1972-08-3       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    


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

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Mason                                         TRANS-DELTA-9-TETRAHYDROCANNABINOL                          DATE: 05/20/95      
EXPERIMENT: 05214 TEST: 01                                                                                     TIME: 12:27:42      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-85212                              ROUTE: GAVAGE                                                  NTP C#: 56371B      
PATHOLOGIST: K. MURTHY                                                                                         CAS: 1972-08-3      

                        TRANS-DELTA-9-TETRAHYDROCANNABINOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 725 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0       MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 80     UNCENSORED DEATHS 29     CENSORED DEATHS 29   TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      438   499   500   505   508   516   524   540   556   566                 |
 |      585   600   616   616   617   627   637   647   659   662                 |
 |      671   678   683   683   709   715   717   718   721                       |
 |  CENSORED DEATHS                                                               |
 |      113   448   448   449   449   450   450   451   451   452                 |
 |      452   456   456   456   456   456   456   456   456   456                 |
 |      456   456   456   456   456   456   456   456   456                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 12.5    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 16     CENSORED DEATHS 9    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      282   368   456   527   600   610   627   637   643   662                 |
 |      674   675   676   679   686   690                                         |
 |  CENSORED DEATHS                                                               |
 |      448   448   449   449   450   450   450   451   452                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 25      MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 17     CENSORED DEATHS 20   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      211   289   324   325   378   450   592   640   650   651                 |
 |      653   659   668   674   709   709   709                                   |
 |  CENSORED DEATHS                                                               |
 |      88    448   448   449   449   450   450   451   451   452                 |
 |      456   456   456   456   456   456   456   456   456   595                 |
 |                                                                                |
 ==================================================================================

                        TRANS-DELTA-9-TETRAHYDROCANNABINOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 725 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 50      MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 20     CENSORED DEATHS 19   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      221   301   369   396   515   531   563   578   592   610                 |
 |      611   659   662   668   684   687   688   690   697   710                 |
 |  CENSORED DEATHS                                                               |
 |      448   448   449   449   450   450   451   451   452   456                 |
 |      456   456   456   456   456   456   456   456   589                       |
 |                                                                                |
 ==================================================================================

                        TRANS-DELTA-9-TETRAHYDROCANNABINOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 725 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   725 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0          |   100.0 100.0 100.0 100.0 100.0  98.7  84.9  77.0  61.2  43.4      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |12.5       |   100.0 100.0 100.0  98.3  96.7  94.7  92.7  90.7  80.9  69.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |25         |   100.0 100.0  98.6  94.2  92.8  91.2  91.2  89.2  78.8  68.4      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |50         |   100.0 100.0  98.6  97.1  94.3  94.3  90.4  84.4  76.4  62.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0            12.5         25           50       |
 |                                MG/KG        MG/KG        MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       43.4%        69.0%        68.4%        62.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.254N     P=0.020N     P=0.047N     P=0.131N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       610.8        593.3        546.5        571.6    |
 |NATURAL DEATHS (C)      |       (15.1)       (30.7)       (42.1)       (32.0)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       581.1        648.6        600.7        609.3    |
 |(STANDARD ERROR)        |       (14.6)       (15.4)       (18.7)       (16.2)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                        TRANS-DELTA-9-TETRAHYDROCANNABINOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 725 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0       MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 26     CENSORED DEATHS 11   TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      365   374   405   435   516   524   528   534   546   576                 |
 |      590   590   620   626   626   632   632   633   637   638                 |
 |      645   647   661   676   681   724                                         |
 |  CENSORED DEATHS                                                               |
 |      435   454   454   455   455   456   456   457   457   458                 |
 |      694                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 12.5    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 11     CENSORED DEATHS 9    TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      276   534   558   565   584   590   619   650   659   681                 |
 |      701                                                                       |
 |  CENSORED DEATHS                                                               |
 |      454   454   455   455   456   456   457   457   458                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 25      MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 15     CENSORED DEATHS 12   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      509   562   605   623   628   639   644   647   650   656                 |
 |      661   694   696   715   721                                               |
 |  CENSORED DEATHS                                                               |
 |      106   426   454   454   455   455   456   456   457   457                 |
 |      458   639                                                                 |
 |                                                                                |
 ==================================================================================

                        TRANS-DELTA-9-TETRAHYDROCANNABINOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 725 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 50      MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 15     CENSORED DEATHS 13   TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      449   454   490   588   602   612   628   638   639   651                 |
 |      651   656   659   659   717                                               |
 |  CENSORED DEATHS                                                               |
 |      16    34    441   454   454   455   455   456   456   457                 |
 |      457   458   458                                                           |
 |                                                                                |
 ==================================================================================

                        TRANS-DELTA-9-TETRAHYDROCANNABINOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 725 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   725 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0          |   100.0 100.0 100.0  98.3  95.0  93.3  85.2  77.1  54.8  48.6      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |12.5       |   100.0 100.0 100.0  98.3  98.3  98.3  96.4  88.5  82.6  78.7      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |25         |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  93.9  77.3  69.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |50         |   100.0 100.0 100.0 100.0 100.0  96.5  94.3  90.1  70.8  68.6      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0            12.5         25           50       |
 |                                MG/KG        MG/KG        MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       48.6%        78.7%        69.0%        68.6%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.128N     P=0.002N     P=0.021N     P=0.046N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       579.3        583.4        643.3        606.2    |
 |NATURAL DEATHS (C)      |       (18.8)       (34.7)       (14.4)       (20.5)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       616.1        658.7        647.5        622.4    |
 |(STANDARD ERROR)        |       (15.1)       (14.5)       (16.1)       (20.3)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                 TRANS-DELTA-9-TETRAHYDROCANNABINOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0       MG/KG    = 1
                                                        12.5    MG/KG    = 2
                                                        25      MG/KG    = 3
                                                        50      MG/KG    = 4

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

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

      |
      |
  100 + 1                                 34         2                       1
      |                                   34         234    3     2          1   2     1
      |                                                     3     43   4         2     114  2
      |                                                            3            3        4  2          2
P  90 +                                                                         3       11 14    4    32 2 2 3
E     |                                                                                    1  1  4 4  4    2233
R     |                                                                                       1 1     4  4  22
C     |                                                                                         11           233 2
E  80 +                                                                                          1  1  1 4     3 232
N     |                                                                                                1 1       433
T     |                                                                                                           434   3
      |                                                                                                  11        224
S  70 +                                                                                                   111       22    2
U     |                                                                                                     1 1      44 3 3
R     |                                                                                                       1  1    4 4
V     |                                                                                                                 4 4
I  60 +                                                                                                          111
V     |                                                                                                            11
A     |
L     |                                                                                                             1   11
   50 +
      |
      |
      |                                                                                                                  11
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 23 obs hidden.

                                                 TRANS-DELTA-9-TETRAHYDROCANNABINOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0       MG/KG    = 1
                                                        12.5    MG/KG    = 2
                                                        25      MG/KG    = 3
                                                        50      MG/KG    = 4

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

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

      |
      |
  100 + 1                                           2             1             4       3
      |                                             2             11    1       4    4  3    2  23
      |                                                                 1    1       4          22  4   3 3
      |                                                                      1           1 1     2  2  4  33
P  90 +                                                                                    11       2 24 4 3 3
E     |                                                                                     11        2  424  2
R     |                                                                                      11            4 32  2
C     |                                                                                       1    1         433 2  2
E  80 +                                                                                            1  1        3 3  2  2
N     |                                                                                               1   1   44 3    32  2
T     |                                                                                                   11   4 4
      |                                                                                                               3  3
S  70 +                                                                                                    11    4       33
U     |                                                                                                                  44
R     |
V     |                                                                                                     11
I  60 +                                                                                                      11
V     |                                                                                                       1  1
A     |                                                                                                          1 1
L     |                                                                                                            11
   50 +                                                                                                             1     1
      |                                                                                                                   1
      |
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 14 obs hidden.