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TDMS Study 88035-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                         PRIMACLONE                                      DATE: 12/27/96       
EXPERIMENT: 88035 TEST: 05                                                                                     TIME: 13:25:44       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-05295                              ROUTE: DOSED FEED                                              NTP C#: C88035       
PATHOLOGIST: TOFT, J.                                                                                          CAS: 0000125-33-7    
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       MERGE   001   001                        0 PPM                                               
                                       MERGE   002   002                        0 PPM                                               
                                       MERGE   003   003                        600 PPM                                             
                                       MERGE   004   004                        600 PPM                                             
                                       MERGE   005   005                        1300 PPM                                            
                                       MERGE   006   006                        1300 PPM                                            
                                       MERGE   007   007                        2500 PPM                                            
                                       MERGE   008   008                        2500 PPM                                            
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Columbus                                         PRIMACLONE                                      DATE: 12/27/96      
EXPERIMENT: 88035 TEST: 05                                                                                     TIME: 13:25:44      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-05295                              ROUTE: DOSED FEED                                              NTP C#: C88035      
PATHOLOGIST: TOFT, J.                                                                                          CAS: 0000125-33-7   
                                    PRIMACLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 723 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 37     CENSORED DEATHS 0    TERMINAL 13        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      281   305   457   463   505   509   526   560   568   574                 |
 |      575   583   585   591   619   627   641   645   646   652                 |
 |      655   655   662   667   669   669   674   676   683   692                 |
 |      697   698   704   710   710   715   719                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 600 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 43     CENSORED DEATHS 0    TERMINAL 7         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      330   502   502   503   526   542   544   562   579   583                 |
 |      609   610   619   619   627   634   635   635   641   641                 |
 |      642   652   654   661   669   669   669   670   673   674                 |
 |      674   683   683   694   697   697   703   709   709   710                 |
 |      712   712   715                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1300 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 46     CENSORED DEATHS 0    TERMINAL 4         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      354   437   529   551   558   561   562   572   576   583                 |
 |      585   589   589   599   612   613   613   619   627   627                 |
 |      631   632   635   635   641   641   643   648   654   655                 |
 |      659   664   667   667   668   669   673   674   683   683                 |
 |      683   688   691   697   698   712                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                    PRIMACLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 723 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 2500 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 50     CENSORED DEATHS 0    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      254   380   436   437   437   505   517   522   529   532                 |
 |      533   537   538   542   544   548   556   559   560   561                 |
 |      561   562   569   572   573   581   583   583   585   585                 |
 |      585   588   589   589   589   589   589   589   589   596                 |
 |      599   599   603   610   619   619   626   632   641   674                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                    PRIMACLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 723 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   723 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0  96.0  96.0  92.0  86.0  72.0  54.0  26.0      |
 |           |                                                                    |
 |           |                                                                    |
 |600 PPM    |   100.0 100.0 100.0  98.0  98.0  98.0  86.0  80.0  52.0  14.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1300 PPM   |   100.0 100.0 100.0  98.0  98.0  96.0  94.0  72.0  36.0   8.0      |
 |           |                                                                    |
 |           |                                                                    |
 |2500 PPM   |   100.0 100.0  98.0  98.0  96.0  90.0  70.0  14.0   2.0   0.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        600 PPM      1300 PPM     2500 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       26.0%        14.0%         8.0%         0.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.324      P=0.016      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       609.9        632.0        622.8        557.9    |
 |NATURAL DEATHS (C)      |       (17.2)       (11.8)       ( 9.9)       ( 9.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       639.3        644.7        630.8        557.9    |
 |(STANDARD ERROR)        |       (14.5)       (11.1)       ( 9.9)       ( 9.8)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                    PRIMACLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 722 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 26     CENSORED DEATHS 0    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      367   415   536   541   561   566   626   626   634   638                 |
 |      640   641   641   646   660   664   668   668   675   682                 |
 |      697   702   702   702   702   703                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 600 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      367   410   415   419   426   456   466   511   567   578                 |
 |      578   584   605   612   618   618   645   675   675   675                 |
 |      682   702   702                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1300 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      389   456   501   543   550   603   610   618   634   644                 |
 |      668   682   690   693   695   696   703   707   709                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                    PRIMACLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 722 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 2500 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      433   477   489   491   543   548   550   561   590   596                 |
 |      605   605   626   674   674   675   682   702   702   708                 |
 |      708   718                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                    PRIMACLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 722 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   722 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0 100.0  96.0  96.0  92.0  88.0  68.0  48.0      |
 |           |                                                                    |
 |           |                                                                    |
 |600 PPM    |   100.0 100.0 100.0 100.0  92.0  86.0  84.0  74.0  66.0  54.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1300 PPM   |   100.0 100.0 100.0 100.0  98.0  96.0  92.0  88.0  80.0  62.0      |
 |           |                                                                    |
 |           |                                                                    |
 |2500 PPM   |   100.0 100.0 100.0 100.0 100.0  96.0  90.0  76.0  74.0  56.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        600 PPM      1300 PPM     2500 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       48.0%        54.0%        62.0%        56.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.450N     P=0.968N     P=0.219N     P=0.597N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       627.0        564.6        620.6        607.1    |
 |NATURAL DEATHS (C)      |       (16.7)       (22.4)       (21.4)       (18.5)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       672.6        649.6        683.5        671.5    |
 |(STANDARD ERROR)        |       (11.0)       (15.2)       (10.6)       (11.4)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                             PRIMACLONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        600 PPM          = 2
                                                        1300 PPM         = 3
                                                        2500 PPM         = 4

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

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

      |
      |
  112 +
      |
      |
      | 1                                        4   1  1    2  3    4       3         2
   96 +                                                 1            4       3   11         3  3
      |                                                                      4    1    21   2 2333
P     |                                                                                 14 41 2 123
E     |                                                                                    44   12122
R  80 +                                                                                     44    111 3 22
C     |                                                                                      44     1 13 22
E     |                                                                                       44      13 3112
N     |                                                                                        44        331 11
T  64 +                                                                                         44        332211
      |                                                                                                    332 2
S     |                                                                                          44            1 11
U     |                                                                                           44        33   22
R  48 +                                                                                            44        33   11
V     |                                                                                                       33  2111
I     |                                                                                                        3 3 2211
V     |                                                                                             4 4          33 2 111
A  32 +                                                                                                                 11
L     |                                                                                                           33  22211
      |                                                                                               44           33
      |                                                                                                             33
   16 +                                                                                                444           33 222
      |                                                                                                  44           3 3
      |                                                                                                   444           3 3
      |                                                                                                     44     4
    0 +                                                                                                            4
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 44 obs hidden.
                                                             PRIMACLONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        600 PPM          = 2
                                                        1300 PPM         = 3
                                                        2500 PPM         = 4

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

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

      |
      |
  100 + 1                                                         1   3     4
      |                                                           1   3  21 4    3  4
      |                                                                  21      3  4443     11
      |                                                                   22          4       13 1
P  90 +                                                                    2     2            43        3
E     |                                                                          22              1      33 1
R     |                                                                           2     2      4 2    4  3311
C     |                                                                                          2 2  44    11
E  80 +                                                                                                44    3    3
N     |                                                                                            22             3 3
T     |                                                                                             2   22 4 11    433
      |                                                                                                  22   1  1   33
S  70 +
U     |                                                                                                   2   2  1144 33
R     |                                                                                                       2   114  33
V     |                                                                                                            11  43 3
I  60 +                                                                                                            21 1
V     |                                                                                                             2 1144
A     |                                                                                                                2 42
L     |
   50 +
      |                                                                                                                1  1
      |
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 29 obs hidden.