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TDMS Study 05150-01 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Mason                                            METHLYPHENIDATE HYDROCHLORIDE                            DATE: 05/20/95       
EXPERIMENT: 05150 TEST: 01                                                                                     TIME: 09:27:46       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01ES65132                                ROUTE: DOSED FEED                                              NTP C#: 266          
PATHOLOGIST: A. RUSSFIELD                                                                                      CAS: 298-59-9        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Mason                                            METHLYPHENIDATE HYDROCHLORIDE                            DATE: 05/20/95      
EXPERIMENT: 05150 TEST: 01                                                                                     TIME: 09:27:46      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01ES65132                                ROUTE: DOSED FEED                                              NTP C#: 266         
PATHOLOGIST: A. RUSSFIELD                                                                                      CAS: 298-59-9       

                           METHLYPHENIDATE HYDROCHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 22     CENSORED DEATHS 20   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      304   391   459   524   549   550   566   594   612   632                 |
 |      632   635   639   665   672   677   677   695   698   701                 |
 |      715   717                                                                 |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   275   276   276   276   276   276                 |
 |      462   462   462   462   462   463   463   463   463   463                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 100 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 16     CENSORED DEATHS 21   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      315   409   429   533   547   596   600   623   639   650                 |
 |      650   675   676   687   717   724                                         |
 |  CENSORED DEATHS                                                               |
 |      43    275   275   275   275   276   276   276   276   276                 |
 |      276   462   462   462   463   463   463   463   463   463                 |
 |      463                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 500 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 16     CENSORED DEATHS 20   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      325   383   406   542   566   624   638   653   674   676                 |
 |      677   681   700   701   721   722                                         |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   275   275   276   276   276   276                 |
 |      462   462   462   462   462   463   463   463   463   463                 |
 |                                                                                |
 ==================================================================================

                           METHLYPHENIDATE HYDROCHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 17     CENSORED DEATHS 19   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      180   185   187   357   386   439   518   590   598   639                 |
 |      653   675   678   682   682   686   722                                   |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   276   276   276   276   276   462                 |
 |      462   462   462   462   462   462   463   463   463                       |
 |                                                                                |
 ==================================================================================

                           METHLYPHENIDATE HYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE 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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0  98.3  96.7  95.0  93.0  84.9  72.8  56.6      |
 |           |                                                                    |
 |           |                                                                    |
 |100 PPM    |   100.0 100.0 100.0  98.3  96.6  94.9  92.9  86.7  78.4  68.1      |
 |           |                                                                    |
 |           |                                                                    |
 |500 PPM    |   100.0 100.0 100.0  98.3  95.0  95.0  93.0  91.0  84.9  68.7      |
 |           |                                                                    |
 |           |                                                                    |
 |1000 PPM   |   100.0  98.6  95.7  94.1  92.4  90.8  88.7  84.7  80.7  68.6      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        100 PPM      500 PPM      1000 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       56.6%        68.1%        68.7%        68.6%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.529N     P=0.344N     P=0.257N     P=0.426N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       604.7        591.9        605.6        521.0    |
 |NATURAL DEATHS (C)      |       (23.0)       (29.5)       (31.8)       (47.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       587.1        585.0        597.9        582.1    |
 |(STANDARD ERROR)        |       (20.0)       (21.8)       (20.6)       (22.2)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                           METHLYPHENIDATE HYDROCHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 19     CENSORED DEATHS 20   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      260   450   551   563   575   613   648   649   650   660                 |
 |      660   662   668   675   677   680   684   728   729                       |
 |  CENSORED DEATHS                                                               |
 |      281   281   281   281   282   282   282   282   282   282                 |
 |      463   463   463   463   463   463   464   464   464   464                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 100 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 18     CENSORED DEATHS 20   TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      450   488   494   579   619   632   660   671   681   685                 |
 |      699   712   713   718   720   721   728   729                             |
 |  CENSORED DEATHS                                                               |
 |      281   281   281   281   281   282   282   282   282   282                 |
 |      463   463   463   464   464   464   464   464   464   464                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 500 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 14     CENSORED DEATHS 20   TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      288   425   466   539   546   567   588   638   646   675                 |
 |      675   688   730   730                                                     |
 |  CENSORED DEATHS                                                               |
 |      281   281   281   281   281   281   282   282   282   282                 |
 |      463   463   463   463   463   464   464   464   464   464                 |
 |                                                                                |
 ==================================================================================

                           METHLYPHENIDATE HYDROCHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 11     CENSORED DEATHS 20   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      404   442   530   559   591   619   637   658   669   676                 |
 |      714                                                                       |
 |  CENSORED DEATHS                                                               |
 |      281   281   281   281   281   282   282   282   282   282                 |
 |      463   463   463   463   463   463   464   464   464   464                 |
 |                                                                                |
 ==================================================================================

                           METHLYPHENIDATE HYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       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 PPM      |   100.0 100.0  98.6  98.6  98.6  96.9  96.9  90.8  76.7  62.6      |
 |           |                                                                    |
 |           |                                                                    |
 |100 PPM    |   100.0 100.0 100.0 100.0 100.0  98.3  94.3  92.3  86.3  64.2      |
 |           |                                                                    |
 |           |                                                                    |
 |500 PPM    |   100.0 100.0 100.0  98.3  96.7  94.7  92.6  86.6  82.6  72.5      |
 |           |                                                                    |
 |           |                                                                    |
 |1000 PPM   |   100.0 100.0 100.0 100.0  98.3  96.7  94.7  90.6  84.6  78.5      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        100 PPM      500 PPM      1000 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       62.6%        64.2%        72.5%        78.5%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.096N     P=0.818N     P=0.426N     P=0.154N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       620.1        649.9        585.8        590.8    |
 |NATURAL DEATHS (C)      |       (25.1)       (21.1)       (33.8)       (29.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       601.1        610.5        602.6        609.9    |
 |(STANDARD ERROR)        |       (20.4)       (20.2)       (20.8)       (20.5)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                   METHLYPHENIDATE HYDROCHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        100 PPM          = 2
                                                        500 PPM          = 3
                                                        1000 PPM         = 4

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

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

      |
      |
  100 + 1                            4                  1 2 3
      |                              44                 1 2 3        31  2
      |
      |                               4                         4    31 32  2    1
   95 +                                                                 3   2    1         1 23
      |                                                         4     4
      |                                                               4      4             1 231 3
      |                                                                      4           4     2 3     2   3
   90 +
      |                                                                                  4     1 1    4    3 3
P     |                                                                                          1    1      3 3
E     |                                                                                               42  2
R  85 +                                                                                               14 12  2 3   3
C     |
E     |                                                                                                  1  1224
N     |                                                                                                        4   4
T  80 +
      |                                                                                                       2    23
S     |
U     |                                                                                                     11     43 3
R  75 +                                                                                                      1   1    33
V     |                                                                                                            2 2
I     |                                                                                                          11  2 3 2
V     |                                                                                                           11     33
A  70 +                                                                                                             4    22
L     |                                                                                                                   3 3
      |                                                                                                                   2 2
      |                                                                                                            1  1
   65 +
      |
      |                                                                                                               11
      |                                                                                                                1 1
   60 +
      |
      |
      |                                                                                                                  1  1
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 13 obs hidden.

                                                   METHLYPHENIDATE HYDROCHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        100 PPM          = 2
                                                        500 PPM          = 3
                                                        1000 PPM         = 4

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

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

      |
      |
  100 + 1                                         1   3                 4       2
      |                                           1   3                 4  3  4 1    2
      |                                                                         1              1
      |                                                                    3  4   3  22     4
   95 +                                                                           3         43 141
      |                                                                               2            2
      |                                                                                      33 41 1  4   2
      |                                                                                       3  3 1  4  14
P  90 +                                                                                                   2 2
E     |                                                                                          3  3    14 2 1  2
R     |
C     |                                                                                             3       43 4 22
E  85 +                                                                                                      334  4
N     |                                                                                                           2 2
T     |                                                                                                       1  143
      |
S  80 +                                                                                                            42 2 4
U     |                                                                                                            3 32 2    4
R     |
V     |                                                                                                          11  3      3
I  75 +                                                                                                           11
V     |                                                                                                                 22
A     |                                                                                                                     33
L     |                                                                                                            11
   70 +
      |                                                                                                                  22
      |
      |                                                                                                             1     1 2
   65 +                                                                                                                   1 1
      |                                                                                                                     22
      |                                                                                                                     11
      |
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 10 obs hidden.