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TDMS Study 05100-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                     TRICRESYL PHOSPHATE                                 DATE: 11/09/95       
EXPERIMENT: 05100 TEST: 03                                                                                     TIME: 14:18:23       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-45050                              ROUTE: DOSED FEED                                              NTP C#: 10277D       
PATHOLOGIST: M. RYAN                                                                                           CAS: 1330-78-5       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Columbus                                     TRICRESYL PHOSPHATE                                 DATE: 11/09/95      
EXPERIMENT: 05100 TEST: 03                                                                                     TIME: 14:18:23      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-45050                              ROUTE: DOSED FEED                                              NTP C#: 10277D      
PATHOLOGIST: M. RYAN                                                                                           CAS: 1330-78-5      
                                TRICRESYL PHOSPHATE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 95     UNCENSORED DEATHS 19     CENSORED DEATHS 44   TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      87    478   486   500   558   572   592   625   647   647                 |
 |      673   680   683   690   701   701   702   722   725                       |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    93    93    93    93    93                  |
 |      96    96    96    96    96    273   273   273   273   273                 |
 |      273   273   273   273   278   278   278   278   278   455                 |
 |      455   455   455   455   455   455   455   455   455   457                 |
 |      457   457   457   457                                                     |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 75 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 95     UNCENSORED DEATHS 20     CENSORED DEATHS 45   TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      263   455   498   537   586   590   611   614   614   635                 |
 |      640   648   652   662   690   691   699   701   702   725                 |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    93    93    93    93    93                  |
 |      96    96    96    96    96    273   273   273   273   273                 |
 |      273   273   273   273   273   278   278   278   278   278                 |
 |      455   455   455   455   455   455   455   455   455   455                 |
 |      457   457   457   457   457                                               |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 150 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 95     UNCENSORED DEATHS 15     CENSORED DEATHS 45   TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      269   454   488   491   529   553   614   618   624   638                 |
 |      682   701   711   722   722                                               |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    93    93    93    93    93                  |
 |      96    96    96    96    96    273   273   273   273   273                 |
 |      273   273   273   273   273   278   278   278   278   278                 |
 |      455   455   455   455   455   455   455   455   455   455                 |
 |      457   457   457   457   457                                               |
 |                                                                                |
 ==================================================================================
                                TRICRESYL PHOSPHATE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 300 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 95     UNCENSORED DEATHS 22     CENSORED DEATHS 45   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      498   542   578   589   605   614   614   618   628   631                 |
 |      638   640   656   662   670   670   691   697   702   705                 |
 |      711   712                                                                 |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    93    93    93    93    93                  |
 |      96    96    96    96    96    273   273   273   273   273                 |
 |      273   273   273   273   273   278   278   278   278   278                 |
 |      455   455   455   455   455   455   455   455   455   455                 |
 |      457   457   457   457   457                                               |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 600 PPM 23 STOP                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 95     UNCENSORED DEATHS 0      CENSORED DEATHS 95   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    93    93    93    93    93                  |
 |      96    96    96    96    96    166   166   166   166   166                 |
 |      166   166   166   166   166   166   166   166   166   166                 |
 |      166   166   166   166   166   166   166   166   166   166                 |
 |      166   166   166   166   166   166   166   166   166   166                 |
 |      166   166   166   166   166   166   166   166   166   166                 |
 |      166   166   166   166   166   273   273   273   273   273                 |
 |      273   273   273   273   273   278   278   278   278   278                 |
 |      455   455   455   455   455   455   455   455   455   455                 |
 |      457   457   457   457   457                                               |
 |                                                                                |
 ==================================================================================
                                TRICRESYL PHOSPHATE

                       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      |    98.9  98.9  98.9  98.9  98.9  97.0  93.0  87.1  81.1  63.3      |
 |           |                                                                    |
 |           |                                                                    |
 |75 PPM     |   100.0 100.0  98.8  98.8  98.8  97.2  93.2  89.1  72.9  60.8      |
 |           |                                                                    |
 |           |                                                                    |
 |150 PPM    |   100.0 100.0  98.8  98.8  98.8  97.2  91.1  89.1  81.0  70.9      |
 |           |                                                                    |
 |           |                                                                    |
 |300 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  90.0  72.0  56.0      |
 |           |                                                                    |
 |           |                                                                    |
 |600        |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |PPM 23 STOP|                                                                    |
 |           |                                                                    |
 ==================================================================================
                                TRICRESYL PHOSPHATE

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

 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                           DOSE                                              |
 |                                                                                                                             |
 |                                0 PPM              75 PPM             150 PPM            300 PPM            600              |
 |                                                                                                            PPM 23 STOP      |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       63.3%              60.8%              70.9%              56.0%               0.0%            |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.908            P=0.868            P=0.604N           P=0.606            P=1.000N         |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       603.6              610.7              587.7              639.6                 .             |
 |NATURAL DEATHS (C)      |       (34.0)             (24.1)             (32.5)             (12.0)             (  . )           |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       493.5              488.9              491.5              493.1              217.5            |
 |(STANDARD ERROR)        |       (24.8)             (24.4)             (24.7)             (24.2)             (11.9)           |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    

       (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)
                                TRICRESYL PHOSPHATE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 95     UNCENSORED DEATHS 17     CENSORED DEATHS 44   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      134   412   488   502   537   553   557   564   578   592                 |
 |      619   638   652   667   675   712   722                                   |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    93    93    93    93    93                  |
 |      97    97    97    97    97    274   274   274   274   274                 |
 |      274   274   274   274   274   278   278   278   278   278                 |
 |      456   456   456   456   456   456   456   456   456   457                 |
 |      457   457   457   457                                                     |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 75 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 95     UNCENSORED DEATHS 15     CENSORED DEATHS 42   TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      204   222   285   397   464   558   620   624   653   687                 |
 |      701   705   705   707   712                                               |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    93    93    93    93    93                  |
 |      97    97    97    97    97    274   274   274   274   274                 |
 |      274   274   274   274   274   278   278   278   278   456                 |
 |      456   456   456   456   456   456   456   457   457   457                 |
 |      457   457                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 150 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 95     UNCENSORED DEATHS 20     CENSORED DEATHS 45   TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      372   592   611   619   624   637   642   653   666   670                 |
 |      670   697   704   705   705   705   705   712   722   724                 |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    93    93    93    93    93                  |
 |      97    97    97    97    97    274   274   274   274   274                 |
 |      274   274   274   274   274   278   278   278   278   278                 |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |      457   457   457   457   457                                               |
 |                                                                                |
 ==================================================================================
                                TRICRESYL PHOSPHATE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 300 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 95     UNCENSORED DEATHS 23     CENSORED DEATHS 46   TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      24    353   546   550   558   564   592   620   625   653                 |
 |      659   667   670   687   687   691   698   699   703   704                 |
 |      712   722   722                                                           |
 |  CENSORED DEATHS                                                               |
 |      2     92    92    92    92    92    92    93    93    93                  |
 |      93    93    97    97    97    97    274   274   274   274                 |
 |      274   274   274   274   274   274   278   278   278   278                 |
 |      278   456   456   456   456   456   456   456   456   456                 |
 |      456   457   457   457   457   457                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 600 PPM 23 STOP                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 95     UNCENSORED DEATHS 1      CENSORED DEATHS 94   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      422                                                                       |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    93    93    93    93    93                  |
 |      97    97    97    97    97    166   166   166   166   166                 |
 |      166   166   166   166   166   166   166   166   166   166                 |
 |      166   166   166   166   166   166   166   166   166   166                 |
 |      166   166   166   166   166   166   166   166   166   166                 |
 |      166   166   166   166   166   166   166   166   166   166                 |
 |      166   166   166   166   166   274   274   274   274   274                 |
 |      274   274   274   274   274   278   278   278   278   278                 |
 |      456   456   456   456   456   456   456   456   456   457                 |
 |      457   457   457   457                                                     |
 |                                                                                |
 ==================================================================================
                                TRICRESYL PHOSPHATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE 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  98.8  98.8  98.8  97.2  97.2  91.3  81.3  75.4  67.4      |
 |           |                                                                    |
 |           |                                                                    |
 |75 PPM     |   100.0 100.0  97.5  96.0  94.5  92.5  92.5  90.6  84.8  73.2      |
 |           |                                                                    |
 |           |                                                                    |
 |150 PPM    |   100.0 100.0 100.0 100.0  98.5  98.5  98.5  96.5  84.4  60.3      |
 |           |                                                                    |
 |           |                                                                    |
 |300 PPM    |    98.9  98.9  98.9  97.4  97.4  97.4  97.4  87.0  78.7  53.9      |
 |           |                                                                    |
 |           |                                                                    |
 |600        |   100.0 100.0 100.0 100.0  93.3   0.0   0.0   0.0   0.0   0.0      |
 |PPM 23 STOP|                                                                    |
 |           |                                                                    |
 ==================================================================================
                                TRICRESYL PHOSPHATE

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

 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                           DOSE                                              |
 |                                                                                                                             |
 |                                0 PPM              75 PPM             150 PPM            300 PPM            600              |
 |                                                                                                            PPM 23 STOP      |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       67.4%              73.2%              60.3%              53.9%               0.0%            |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.190            P=0.681N           P=0.877            P=0.357            P=1.000          |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       564.8              549.6              656.8              613.3              422.0            |
 |NATURAL DEATHS (C)      |       (33.5)             (48.3)             (17.5)             (32.1)             (  . )           |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       487.5              496.2              498.8              478.3              217.4            |
 |(STANDARD ERROR)        |       (24.6)             (25.3)             (24.7)             (25.1)             (11.8)           |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    

       (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)
                                                        TRICRESYL PHOSPHATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        75 PPM           = 2
                                                        150 PPM          = 3
                                                        300 PPM          = 4
                                                        600 PPM 23 STOP  = 5

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

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

      |
  100 + 1             1                           23                            2   1  4
      |                                                                         2   11 2      4
      |                                                                              131     24    4  4
      |                                                                               31    32  1   2 4 4
   90 +                                                                                     3  31 1 2 1 42
      |                                                                                               1  331
      |                                                                                                  431  1
      |                                                                                                  2 323
   80 +                                                                                                     221    11  3
      |                                                                                                       22       33
      |                                                                                                      4 2 2  11  3 3
      |                                                                                                          24  1 1
P  70 +                                                                                                              22   3 3
E     |                                                                                                           4  421  1
R     |                                                                                                              444
C     |                                                                                                                2  1 1
E  60 +                                                                                                                44 2 2
N     |
T     |                                                                                                                 4   4
      |
S  50 +
U     |
R     |
V     |
I  40 +
V     |
A     |
L     |
   30 +
      |
      |
      |
   20 +
      |
      |
      |
   10 +
      |
      |
      |
    0 +                                                                             5
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 43 obs hidden.
                                                        TRICRESYL PHOSPHATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        75 PPM           = 2
                                                        150 PPM          = 3
                                                        300 PPM          = 4
                                                        600 PPM 23 STOP  = 5

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

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

      |
  100 + 1   4                 1          2 2                    4  3     1 5
      |                                    2         2          4  3     1           1        4       3  3
      |                                              2                 2          2  1 1      44         33
      |                                                                    5      2    1     1 12         33
   90 +                                                                                        114    4   233
      |                                                                                         11    4   2233 2
      |                                                                                          1 1      44   2  3  2
      |                                                                                            1  1   14   4     2 2
   80 +                                                                                                   1  1 4 4
      |                                                                                                      1 1 43   33
      |                                                                                                        1  1  4 22
      |                                                                                                           11    1   2
P  70 +                                                                                                                 1 1
E     |                                                                                                              4433 1 1
R     |                                                                                                               443 3
C     |
E  60 +                                                                                                                44 3 3
N     |                                                                                                                 4 4
T     |                                                                                                                   4 4
      |
S  50 +
U     |
R     |
V     |
I  40 +
V     |
A     |
L     |
   30 +
      |
      |
      |
   20 +
      |
      |
      |
   10 +
      |
      |
      |
    0 +                                                                           5
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 27 obs hidden.