National Toxicology Program

National Toxicology Program
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TR 387 Rat Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Microbiological Assoc.                                    DATE: 09/04/94   
EXP: 05029                  DL AMPHETAMINE SULFATE             TIME: 11:18:17   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 55710    
CONT: N01CP9565001                                             CAS: 60-13-9     
PATHOLOGIST: R. KOVATCH                                                         
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Microbiological Assoc.                                    DATE: 09/04/94  
EXP: 05029                  DL AMPHETAMINE SULFATE             TIME: 11:18:17  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 55710   
CONT: N01CP9565001                                             CAS: 60-13-9    
PATHOLOGIST: R. KOVATCH                                                        

                              DL AMPHETAMINE SULFATE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      316   512   533   558   579   625   634   637   638   659                 |
 |      664   676   684   684   691   695   708   717   722   726                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = LOW  M/F20PPM                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      236   384   415   437   467   524   576   585   655   660                 |
 |      666   667   674   682   688   694   695   705   723                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = HIGH M/F100 PPM                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      436   436   498   582   607   621   627   639   659   660                 |
 |      666   675   695   703   711   722   726                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                              DL AMPHETAMINE SULFATE


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0  98.0  98.0  98.0  94.0  90.0  78.0  60.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |LOW        |   100.0 100.0  98.0  98.0  94.0  90.0  88.0  84.0  80.0  62.0      |
 |M/F20PPM   |                                                                    |
 |           |                                                                    |
 |HIGH       |   100.0 100.0 100.0 100.0 100.0  96.0  94.0  92.0  80.0  66.0      |
 |M/F100 PPM |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE          LOW              HIGH          |
 |                                CONTROL          M/F20PPM         M/F100 PPM    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       60.0%            62.0%            66.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.623N         P=1.000N         P=0.680N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       632.9            585.9            627.2         |
 |NATURAL DEATHS (C)      |       (21.7)           (31.5)           (22.2)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       690.6            674.6            694.4         |
 |(STANDARD ERROR)        |       (10.9)           (15.4)           (10.1)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                              DL AMPHETAMINE SULFATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      478   485   541   547   593   655   660   666   667   677                 |
 |      677   694   701   710   719   719   726                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = LOW  M/F20PPM                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 8      CENSORED DEATHS 0    TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      340   578   590   624   632   666   669   706                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = HIGH M/F100 PPM                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      220   453   453   504   535   604   666   669   676   694                 |
 |      696   710   724                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                              DL AMPHETAMINE SULFATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 731 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   731 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0  96.0  94.0  90.0  86.0  66.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |LOW        |   100.0 100.0 100.0  98.0  98.0  98.0  98.0  94.0  90.0  84.0      |
 |M/F20PPM   |                                                                    |
 |           |                                                                    |
 |HIGH       |   100.0 100.0  98.0  98.0  98.0  94.0  90.0  88.0  88.0  74.0      |
 |M/F100 PPM |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE          LOW              HIGH          |
 |                                CONTROL          M/F20PPM         M/F100 PPM    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       66.0%            84.0%            74.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.965N         P=0.078N         P=0.560N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       642.1            600.6            584.9         |
 |NATURAL DEATHS (C)      |       (19.8)           (40.1)           (40.7)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       700.8            710.1            693.0         |
 |(STANDARD ERROR)        |       ( 8.9)           ( 9.1)           (13.8)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                       DL AMPHETAMINE SULFATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        LOW  M/F20PPM    = 2
                                                        HIGH M/F100 PPM  = 3

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

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

      |
      |
  100 + 1                                    2             1                 3
      |
      |                                      2             1         2                   1
      |
   96 +                                                              2    2  3         3 1   1
      |
      |                                                                   2  2         3     1  1   3
      |
   92 +                                                                      2    2             1  13   3
      |
      |                                                                           2        2       1    3 31
      |
P  88 +                                                                                    2       2      311
E     |
R     |                                                                                            22      3 3
C     |
E  84 +                                                                                             2       11 2 3
N     |
T     |                                                                                                      1 2 1
      |
S  80 +                                                                                                          22
U     |
R     |                                                                                                          131
V     |
I  76 +                                                                                                           211 3
V     |
A     |                                                                                                            22 33
L     |
   72 +                                                                                                             11 33
      |
      |                                                                                                              11 3 3
      |
   68 +                                                                                                               1 1
      |
      |                                                                                                               22113 3
      |
   64 +                                                                                                                2 11
      |
      |                                                                                                                   2 2
      |
   60 +                                                                                                                   1 1
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 15 obs hidden.

                                                       DL AMPHETAMINE SULFATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        LOW  M/F20PPM    = 2
                                                        HIGH M/F100 PPM  = 3

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

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

      |
      |
  100 + 1                                  3                  2                     1
      |
      |                                    3                  2                 3   11             2
      |                                                                              1        1    2  2
   95 +
      |                                                                         3      3      11      2    2
P     |                                                                                3     3 1      1    22
E     |
R  90 +                                                                                      3        1 3   2  1  2
C     |
E     |                                                                                                 3      1 13
N     |                                                                                                          11    2
T  85 +
      |                                                                                                           33   2    2
S     |                                                                                                           11  3
U     |
R  80 +
V     |
I     |                                                                                                            1  1 3
V     |                                                                                                               113 3
A  75 +
L     |                                                                                                                11 3 3
      |                                                                                                                 11
      |
   70 +
      |
      |                                                                                                                  11
      |                                                                                                                   1 1
   65 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 5 obs hidden.

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