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TDMS Study 05132-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                   TETRAFLUOROETHYLENE                                  DATE: 04/04/96       
EXPERIMENT: 05132 TEST: 06                                                                                     TIME: 01:31:44       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01ES85207                                ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 61596B       
PATHOLOGIST: P. MELLICK                                                                                        CAS: 116-14-3        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Northwest                                   TETRAFLUOROETHYLENE                                  DATE: 04/04/96      
EXPERIMENT: 05132 TEST: 06                                                                                     TIME: 01:31:44      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01ES85207                                ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 61596B      
PATHOLOGIST: P. MELLICK                                                                                        CAS: 116-14-3       
                                TETRAFLUOROETHYLENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 666 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 58     UNCENSORED DEATHS 10     CENSORED DEATHS 10   TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      452   475   538   541   597   597   611   639   650   650                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 312 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 58     UNCENSORED DEATHS 37     CENSORED DEATHS 10   TERMINAL 11        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      44    75    77    462   463   495   508   509   513   522                 |
 |      537   537   537   541   541   541   551   552   566   569                 |
 |      573   586   590   593   593   599   600   614   614   616                 |
 |      625   631   637   646   646   649   660                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 625 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 58     UNCENSORED DEATHS 46     CENSORED DEATHS 10   TERMINAL 2         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      363   368   415   420   433   446   447   484   485   497                 |
 |      509   516   517   518   518   531   539   541   541   541                 |
 |      547   548   548   551   554   569   573   586   589   589                 |
 |      593   597   600   607   608   608   615   616   618   631                 |
 |      632   639   646   649   653   657                                         |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================
                                TETRAFLUOROETHYLENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 666 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1250 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 58     UNCENSORED DEATHS 47     CENSORED DEATHS 10   TERMINAL 1         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      5     259   315   356   401   465   483   518   527   527                 |
 |      536   541   541   541   543   544   548   548   551   559                 |
 |      563   565   574   575   578   583   585   586   586   589                 |
 |      599   600   600   606   608   608   608   610   613   613                 |
 |      623   629   630   631   643   646   654                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================
                                TETRAFLUOROETHYLENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 666 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   666 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0  96.2  92.0  87.8  79.5  79.5      |
 |           |                                                                    |
 |           |                                                                    |
 |312 PPM    |    94.8  94.8  94.8  94.8  94.8  90.6  67.4  44.3  23.2  23.2      |
 |           |                                                                    |
 |           |                                                                    |
 |625 PPM    |   100.0 100.0 100.0  98.3  93.1  83.6  60.1  32.2   4.3   4.3      |
 |           |                                                                    |
 |           |                                                                    |
 |1250 PPM   |    98.3  98.3  96.6  93.1  91.4  87.1  68.0  31.9   2.1   2.1      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      312 PPM      625 PPM      1250 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       79.5%        23.2%         4.3%         2.1%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P<0.001      P<0.001      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       575.0        530.1        549.0        545.0    |
 |NATURAL DEATHS (C)      |       (22.4)       (24.5)       (11.1)       (16.7)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       614.1        543.1        537.0        531.7    |
 |(STANDARD ERROR)        |       (11.2)       (17.8)       (10.4)       (14.4)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                TETRAFLUOROETHYLENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 667 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 58     UNCENSORED DEATHS 12     CENSORED DEATHS 10   TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      400   488   531   541   573   595   597   603   617   621                 |
 |      626   660                                                                 |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 312 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 58     UNCENSORED DEATHS 44     CENSORED DEATHS 10   TERMINAL 4         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      429   429   454   455   493   530   530   539   541   541                 |
 |      541   541   566   585   588   596   600   600   603   607                 |
 |      609   614   614   614   614   614   615   618   631   636                 |
 |      636   638   639   639   643   644   645   646   646   646                 |
 |      649   651   657   659                                                     |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 625 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 58     UNCENSORED DEATHS 41     CENSORED DEATHS 11   TERMINAL 6         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      457   476   478   481   484   489   492   510   535   541                 |
 |      541   541   541   552   555   556   566   569   569   569                 |
 |      569   580   589   595   597   608   614   615   619   629                 |
 |      630   630   631   636   642   650   652   653   653   653                 |
 |      661                                                                       |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |      580                                                                       |
 |                                                                                |
 ==================================================================================
                                TETRAFLUOROETHYLENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 667 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1250 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 58     UNCENSORED DEATHS 44     CENSORED DEATHS 10   TERMINAL 4         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      135   144   366   468   484   484   507   509   513   518                 |
 |      536   541   541   548   552   552   555   563   565   569                 |
 |      580   585   586   586   586   587   588   588   589   597                 |
 |      597   600   606   608   608   608   619   623   626   629                 |
 |      639   642   646   646                                                     |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================
                                TETRAFLUOROETHYLENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 667 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   667 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0  98.3  98.3  92.0  83.6  75.3  75.3      |
 |           |                                                                    |
 |           |                                                                    |
 |312 PPM    |   100.0 100.0 100.0 100.0 100.0  93.1  76.2  61.4   8.5   8.5      |
 |           |                                                                    |
 |           |                                                                    |
 |625 PPM    |   100.0 100.0 100.0 100.0 100.0  89.9  73.2  47.8  13.0  13.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1250 PPM   |   100.0  96.6  96.6  96.6  94.8  88.5  73.8  33.7   8.4   8.4      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      312 PPM      625 PPM      1250 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       75.3%         8.5%        13.0%         8.4%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P<0.001      P<0.001      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       571.0        590.6        575.8        550.4    |
 |NATURAL DEATHS (C)      |       (20.7)       ( 9.5)       ( 9.3)       (16.0)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       610.9        572.8        564.8        542.4    |
 |(STANDARD ERROR)        |       (11.3)       (10.4)       ( 9.9)       (13.7)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                        TETRAFLUOROETHYLENE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        312 PPM          = 2
                                                        625 PPM          = 3
                                                        1250 PPM         = 4

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

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

      |
  100 +  14      2                                                     3               1
      |   4      2    2                              4         4       3 3       3     1   1
      |               2                                        4      4                 2  1         1 1
      |                                                               4        4 3 3  3 22             1        1
   90 +                                                                                  2  4 2
      |                                                                               3     432  24             1  1
      |                                                                                          22 4              1   1
      |                                                                                      33  322                   1 1
   80 +                                                                                          33242                   1  1
      |                                                                                              4 4
      |                                                                                              2 2
      |
P  70 +                                                                                           3 3
E     |                                                                                             33 22
R     |
C     |                                                                                                 242
E  60 +                                                                                                33422
N     |                                                                                                    2  2
T     |                                                                                                   44  22
      |                                                                                                 33 4 4
S  50 +                                                                                                  3 3 44
U     |                                                                                                        22
R     |                                                                                                    3  3 2  2
V     |                                                                                                       33
I  40 +                                                                                                       44
V     |                                                                                                        33  2 2
A     |                                                                                                              22
L     |                                                                                                         33    2  2
   30 +
      |
      |                                                                                                          3 3     2 2
      |                                                                                                          4 33      22
   20 +                                                                                                             3 3
      |                                                                                                            44
      |                                                                                                             4433
      |                                                                                                                3 3
   10 +                                                                                                              44
      |                                                                                                               44 33
      |                                                                                                                  43 3
      |                                                                                                                   4 4
    0 +
      |
      ---+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+--
         0          10          20          30          40          50          60          70          80          90          100

                                                                   WEEK

NOTE: 27 obs hidden.
                                                        TETRAFLUOROETHYLENE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        312 PPM          = 2
                                                        625 PPM          = 3
                                                        1250 PPM         = 4

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

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

      |
  100 +  1                       4                                             1   2    3
      |                          44                                      4     1   2   23  3 1
      |                                                                  4               4 331      1  1
      |                                                                                2 4  332        1   1
   90 +                                                                                       2     2      1   1
      |                                                                                      33  4  22         11
      |                                                                                       3  34  2 2        11
      |                                                                                          3   3 3         1  1
   80 +                                                                                           4  4              11
      |                                                                                              4 4             1     1
      |                                                                                                24 2   2            11
      |                                                                                                33
P  70 +                                                                                                 33    2 2
E     |                                                                                                 433
R     |                                                                                                  433
C     |                                                                                                         22
E  60 +                                                                                                   44 4
N     |                                                                                                    3 34  2 2
T     |                                                                                                      3 3
      |
S  50 +                                                                                                        33
U     |                                                                                                         33
R     |                                                                                                          3 22
V     |                                                                                                       44   32 2
I  40 +                                                                                                        44   33
V     |
A     |                                                                                                               22
L     |                                                                                                         44   33
   30 +
      |                                                                                                               33
      |                                                                                                          4  4  2 23
      |
   20 +                                                                                                             44
      |                                                                                                              4 4
      |                                                                                                                   33
      |                                                                                                                4 2233
   10 +                                                                                                                   22
      |                                                                                                                  4 22
      |
      |
    0 +
      |
      ---+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+--
         0          10          20          30          40          50          60          70          80          90          100

                                                                   WEEK

NOTE: 22 obs hidden.