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TDMS Study 05214-02 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Mason                                         TRANS-DELTA-9-TETRAHYDROCANNABINOL                          DATE: 05/20/95       
EXPERIMENT: 05214 TEST: 02                                                                                     TIME: 13:11:29       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85212                              ROUTE: GAVAGE                                                  NTP C#: 56371B       
PATHOLOGIST: F. VOELKER                      M. GOAD                                                           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: 02                                                                                     TIME: 13:11:29      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-85212                              ROUTE: GAVAGE                                                  NTP C#: 56371B      
PATHOLOGIST: F. VOELKER                      M. GOAD                                                           CAS: 1972-08-3      

                        TRANS-DELTA-9-TETRAHYDROCANNABINOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0       MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 80     UNCENSORED DEATHS 12     CENSORED DEATHS 18   TERMINAL 50        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      146   538   554   585   591   672   672   678   678   705                 |
 |      707   723                                                                 |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   461   461   461   461   461                 |
 |      463   463   463   463   463   463   463   463                             |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 125     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 7      CENSORED DEATHS 0    TERMINAL 53        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      563   566   591   598   638   709   725                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 250     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 14     CENSORED DEATHS 11   TERMINAL 45        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      28    94    225   395   405   486   493   508   563   574                 |
 |      611   670   716   728                                                     |
 |  CENSORED DEATHS                                                               |
 |      246   450   461   461   461   461   461   461   461   461                 |
 |      461                                                                       |
 |                                                                                |
 ==================================================================================

                        TRANS-DELTA-9-TETRAHYDROCANNABINOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 500     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 25     CENSORED DEATHS 11   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      6     85    86    191   206   251   256   267   275   418                 |
 |      444   454   454   456   468   503   554   561   563   587                 |
 |      599   600   611   625   629                                               |
 |  CENSORED DEATHS                                                               |
 |      90    461   461   461   461   461   461   461   461   461                 |
 |      461                                                                       |
 |                                                                                |
 ==================================================================================

                        TRANS-DELTA-9-TETRAHYDROCANNABINOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0          |   100.0  98.8  98.8  98.8  98.8  98.8  97.1  92.3  92.3  80.9      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |125        |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  93.3  91.7  88.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |250        |    98.6  97.1  95.7  95.7  92.8  92.8  87.7  84.2  82.5  77.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |500        |    95.7  95.7  88.5  87.0  85.6  78.0  76.2  65.6  60.3  60.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0            125          250          500      |
 |                                MG/KG        MG/KG        MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       80.9%        88.3%        77.3%        60.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.363N     P=0.561      P=0.002  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       604.1        627.1        464.0        406.0    |
 |NATURAL DEATHS (C)      |       (45.4)       (25.1)       (58.1)       (38.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       650.8        718.0        631.3        566.7    |
 |(STANDARD ERROR)        |       (14.1)       ( 5.1)       (19.8)       (23.9)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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 MICE
                       FIRST TERMINAL SACRIFICE AT 737 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0       MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 47        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      30    337   456   518   623   659   677   677   686   695                 |
 |      706   710   732                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 125     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 50        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      247   392   590   661   681   694   699   701   706   714                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 250     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 44        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      5     255   260   308   374   535   543   548   632   644                 |
 |      651   670   674   694   709   732                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                        TRANS-DELTA-9-TETRAHYDROCANNABINOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 737 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 500     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 17     CENSORED DEATHS 2    TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      5     127   145   174   198   215   313   398   495   567                 |
 |      642   672   682   701   722   727   727                                   |
 |  CENSORED DEATHS                                                               |
 |      84    210                                                                 |
 |                                                                                |
 ==================================================================================

                        TRANS-DELTA-9-TETRAHYDROCANNABINOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 737 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   737 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0          |    98.3  98.3  98.3  96.7  96.7  95.0  93.3  93.3  90.0  78.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |125        |   100.0 100.0  98.3  98.3  96.7  96.7  96.7  95.0  93.3  83.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |250        |    98.3  98.3  95.0  93.3  91.7  91.7  88.3  86.7  81.7  73.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |500        |    98.3  93.2  89.8  88.1  86.4  86.4  84.6  82.9  81.2  70.8      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0            125          250          500      |
 |                                MG/KG        MG/KG        MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       78.3%        83.3%        73.3%        70.8%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.162      P=0.610N     P=0.583      P=0.392  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       577.4        608.5        514.6        441.8    |
 |NATURAL DEATHS (C)      |       (55.9)       (50.6)       (52.9)       (62.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       702.4        715.6        677.7        633.7    |
 |(STANDARD ERROR)        |       (14.5)       (10.2)       (18.8)       (27.1)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                 TRANS-DELTA-9-TETRAHYDROCANNABINOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0       MG/KG    = 1
                                                        125     MG/KG    = 2
                                                        250     MG/KG    = 3
                                                        500     MG/KG    = 4

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

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

      |
      |
  100 + 14  3                  1                                                                 2
      |  4  3         43       1                                                             1
      |                3                    3                                                1  1
      |               4                4    3                          3                         2    2
   95 +                                                                                         1   1 22
      |                                4 4                             33                           1 12     2
      |                                  4      4                       3            3                1           1
      |                                         44                                   33                      2          2
P  90 +                                          4 4                                  3 3                               2 2
E     |                                            44                                                             11      2 2
R     |                                             4                     4             3        3
C     |                                                                                          33                1   1
E  85 +                                                                   4   4
N     |                                                                       4 4                 3      3
T     |                                                                                                  3        3    1  1
      |                                                                         44                                3      31 1
S  80 +                                                                          44
U     |                                                                                                                  33
R     |                                                                           4    4                                  3 3
V     |                                                                                4        4
I  75 +                                                                                         44
V     |
A     |
L     |                                                                                          4  4
   70 +
      |                                                                                             4  4
      |
      |
   65 +                                                                                                4 4
      |                                                                                                  4 4
      |
      |
   60 +                                                                                                    4                4
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 3 obs hidden.

                                                 TRANS-DELTA-9-TETRAHYDROCANNABINOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0       MG/KG    = 1
                                                        125     MG/KG    = 2
                                                        250     MG/KG    = 3
                                                        500     MG/KG    = 4

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

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

      |
      |
  100 + 13    1                                 2
      |  3    1              4                  23            1       2
      |
      |                      4 4                 33           1       2          1                    2
P  95 +                        4    4             3     3                        1       1            2          2
E     |                             4   4               3          3                     1                1      2  2
R     |
C     |                                 4 4                        3                         3            1      1  2 2
E  90 +                                   4               4                                  33                  1 1
N     |                                                                                       33                      22
T     |                                                   4            4
      |                                                                4              4        3            3      11
S  85 +                                                                               4          4          33      1 122
U     |                                                                                                      33       112    2
R     |                                                                                          4           4
V     |                                                                                                      43   3    11
I  80 +                                                                                                           334   1   1
V     |                                                                                                            3  3     11
A     |                                                                                                             4  4
L     |                                                                                                               343 4
   75 +                                                                                                                 3   3
      |                                                                                                                     33
      |
      |                                                                                                                   4  4
   70 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 7 obs hidden.