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TDMS Study 88035-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                         PRIMACLONE                                      DATE: 12/30/96       
EXPERIMENT: 88035 TEST: 06                                                                                     TIME: 17:03:36       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-05295                              ROUTE: DOSED FEED                                              NTP C#: C88035       
PATHOLOGIST: PERSING, R.                                                                                       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                        300 PPM                                             
                                       MERGE   004   004                        300 PPM                                             
                                       MERGE   005   005                        600 PPM                                             
                                       MERGE   006   006                        600 PPM                                             
                                       MERGE   007   007                        1300 PPM                                            
                                       MERGE   008   008                        1300 PPM                                            
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Columbus                                         PRIMACLONE                                      DATE: 12/30/96      
EXPERIMENT: 88035 TEST: 06                                                                                     TIME: 17:03:36      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-05295                              ROUTE: DOSED FEED                                              NTP C#: C88035      
PATHOLOGIST: PERSING, R.                                                                                       CAS: 0000125-33-7   
                                    PRIMACLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 726 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      432   511   526   551   552   573   576   578   583   635                 |
 |      642   649   698   701   701                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 300 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      603   603   614   617   617   617   636   639   642   643                 |
 |      646   672   673   695   710   712                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 600 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      422   566   575   578   602   614   619   621   625   643                 |
 |      645   646   652   658   667   681   687   692   701                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                    PRIMACLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 726 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1300 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 31     CENSORED DEATHS 0    TERMINAL 19        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      22    368   470   492   516   551   559   562   565   606                 |
 |      617   625   625   625   632   637   638   646   656   658                 |
 |      674   674   674   697   698   699   702   706   712   716                 |
 |      720                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                    PRIMACLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 726 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   726 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0 100.0 100.0  98.0  94.0  82.0  76.0  70.0      |
 |           |                                                                    |
 |           |                                                                    |
 |300 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  78.0  68.0      |
 |           |                                                                    |
 |           |                                                                    |
 |600 PPM    |   100.0 100.0 100.0 100.0  98.0  98.0  98.0  90.0  72.0  62.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1300 PPM   |    98.0  98.0  98.0  98.0  96.0  94.0  90.0  82.0  60.0  38.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        300 PPM      600 PPM      1300 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       70.0%        68.0%        62.0%        38.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=1.000N     P=0.611      P=0.005  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       593.9        646.2        626.0        604.6    |
 |NATURAL DEATHS (C)      |       (19.9)       ( 9.1)       (14.5)       (24.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       686.4        700.5        688.0        650.7    |
 |(STANDARD ERROR)        |       (10.4)       ( 6.0)       ( 8.8)       (17.2)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                                    PRIMACLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 727 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 0    TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      420   519   595   596   621   621   645   673   694                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 300 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 8      CENSORED DEATHS 0    TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      613   673   690   701   718   720   724   726                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 600 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 5      CENSORED DEATHS 1    TERMINAL 44        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      498   677   680   694   699                                               |
 |  CENSORED DEATHS                                                               |
 |      561                                                                       |
 |                                                                                |
 ==================================================================================
                                    PRIMACLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 727 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1300 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      583   597   631   638   673   673   673   673   677   693                 |
 |      721                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                    PRIMACLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 727 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   727 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0 100.0  98.0  98.0  96.0  92.0  86.0  82.0      |
 |           |                                                                    |
 |           |                                                                    |
 |300 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0  84.0      |
 |           |                                                                    |
 |           |                                                                    |
 |600 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  98.0  98.0  89.8      |
 |           |                                                                    |
 |           |                                                                    |
 |1300 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  92.0  78.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        300 PPM      600 PPM      1300 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       82.0%        84.0%        89.8%        78.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.642      P=0.864N     P=0.359N     P=0.884  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       598.2        695.6        649.6        657.5    |
 |NATURAL DEATHS (C)      |       (27.9)       (13.5)       (38.1)       (12.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       703.8        722.0        715.9        711.7    |
 |(STANDARD ERROR)        |       ( 8.5)       ( 2.6)       ( 5.7)       ( 4.9)   |
 |                        |                                                       |
 ==================================================================================
                                    

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

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

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

      |
      |
  100 + 1   4                                                              31                           2
      |     4                                                     4        31           1        3
      |                                                           4                4  4 1   1  1 3 3    222
      |                                                                               4  4         3   3
   90 +                                                                                  4     1  1    3 3
      |                                                                                        44 11     32 2
P     |                                                                                         44 11     3322
E     |                                                                                          4  1   4  313
R  80 +                                                                                                 4 4 112
C     |                                                                                                   44 11   2
E     |                                                                                                       13  22  11
N     |                                                                                                    44  3  3   2 2
T  70 +                                                                                                           3 3  1  1
      |                                                                                                     44      33  2 2
S     |                                                                                                      444     3 3
U     |                                                                                                                3  3
R  60 +                                                                                                        4   4
V     |
I     |                                                                                                            4  4
V     |
A  50 +
L     |                                                                                                               44
      |                                                                                                                44
      |                                                                                                                 44
   40 +
      |                                                                                                                  44
      |
      |
   30 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 17 obs hidden.
                                                             PRIMACLONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        300 PPM          = 2
                                                        600 PPM          = 3
                                                        1300 PPM         = 4

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

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

      |
      |
  100 + 1                                                                 1            3            4    2
      |
      |                                                                   1            3   1        4  4 2         2
      |
P  96 +                                                                                    1          14    4      232
E     |
R     |                                                                                               11    44      3232
C     |
E  92 +                                                                                                1  1  4     4   2 2
N     |
T     |                                                                                                               3   3
      |
S  88 +                                                                                                   1   1          22
U     |
R     |                                                                                                       1    1
V     |
I  84 +                                                                                                            1  1   2
V     |
A     |                                                                                                            4 41   1
L     |
   80 +                                                                                                              4   4
      |
      |                                                                                                                  44
      |
   76 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 5 obs hidden.