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TDMS Study 88034-04 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Battelle Northwest                                        DATE: 05/08/95   
EXP: 88034                          OZONE                      TIME: 20:53:46   
TEST: 04              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: RESPIRATORY EXPOSURE WHOLE  NTP C#: C88034   
CONT: N01-ES-95239                                             CAS: 10028-15-6  
PATHOLOGIST: S. GRUMBEIN                                                        
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Battelle Northwest                                        DATE: 05/08/95  
EXP: 88034                          OZONE                      TIME: 20:53:46  
TEST: 04              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: RESPIRATORY EXPOSURE WHOLE  NTP C#: C88034  
CONT: N01-ES-95239                                             CAS: 10028-15-6 
PATHOLOGIST: S. GRUMBEIN                                                       

                                       OZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      205   362   446   453   484   525   596   602   608   609                 |
 |      611   612   644   644   653   667   681   695   701   729                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.12 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      440   459   527   540   545   551   567   596   600   612                 |
 |      637   667   681   695   695   699                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 25     CENSORED DEATHS 0    TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      145   460   461   464   484   484   489   522   527   544                 |
 |      559   583   583   583   596   596   621   630   644   653                 |
 |      659   665   681   701   709                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                       OZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1.0 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      80    350   380   446   462   484   506   514   525   551                 |
 |      557   567   592   595   602   612   612   616   630   658                 |
 |      665   681   709                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                       OZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 733 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   733 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0  98.0  96.0  96.0  90.0  88.0  84.0  70.0  60.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.12 PPM   |   100.0 100.0 100.0 100.0 100.0  96.0  90.0  82.0  78.0  68.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5 PPM    |   100.0  98.0  98.0  98.0  98.0  88.0  80.0  68.0  56.0  50.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1.0 PPM    |    98.0  98.0  98.0  96.0  94.0  88.0  82.0  70.0  58.0  54.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      0.12 PPM     0.5 PPM      1.0 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       60.0%        68.0%        50.0%        54.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.157      P=0.519N     P=0.329      P=0.515  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       576.4        594.4        561.7        538.9    |
 |NATURAL DEATHS (C)      |       (29.0)       (20.5)       (23.3)       (28.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       670.3        688.7        647.4        643.7    |
 |(STANDARD ERROR)        |       (15.8)       (11.2)       (16.8)       (18.9)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                       OZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 735 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      439   511   531   538   544   566   601   634   636   638                 |
 |      649   653   667   667   681   689   694   700   723   723                 |
 |      728                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.12 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      471   471   567   594   608   612   653   681   681   681                 |
 |      687   703   723                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 2    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      527   574   634   644   646   659   667   677   678   693                 |
 |      704   709   709   723   728                                               |
 |  CENSORED DEATHS                                                               |
 |      146   488                                                                 |
 |                                                                                |
 ==================================================================================

                                       OZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 735 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1.0 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      482   488   514   516   540   569   611   667   685   685                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                       OZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 735 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   735 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0  98.0  90.0  86.0  76.0  58.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.12 PPM   |   100.0 100.0 100.0 100.0 100.0  96.0  96.0  92.0  86.0  74.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0  97.9  95.8  87.5  68.8      |
 |           |                                                                    |
 |           |                                                                    |
 |1.0 PPM    |   100.0 100.0 100.0 100.0 100.0  98.0  90.0  88.0  86.0  80.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      0.12 PPM     0.5 PPM      1.0 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       58.0%        74.0%        68.8%        80.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.089N     P=0.134N     P=0.276N     P=0.045N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       629.1        625.5        664.8        575.7    |
 |NATURAL DEATHS (C)      |       (17.4)       (22.9)       (14.3)       (25.5)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       690.5        706.5        697.2        703.1    |
 |(STANDARD ERROR)        |       (10.4)       ( 9.0)       (13.6)       (10.3)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                               OZONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        0.12 PPM         = 2
                                                        0.5 PPM          = 3
                                                        1.0 PPM          = 4

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

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

      |
      |
  104 +
      |
      | 1            4         3         1                                   2
      |              4         3         1                     4 1           2   2
   96 +                                                        4 1   4        1  2          2
      |                                                              4        1 133         2 2
P     |                                                                       4 143  1
E     |                                                                          4   1     1  22
R  88 +                                                                              4  4  1   2 2     1
C     |                                                                              3  44 3     2     2
E     |                                                                                  4 33          11
N     |                                                                                    43 34       2 2
T  80 +                                                                                       343       11  2
      |                                                                                         34  3       2     2
S     |                                                                                          4    4  1   1    2 2
U     |                                                                                                             2 2
R  72 +                                                                                             3 43     1 1
V     |                                                                                                4 4     1  1
I     |                                                                                                3  3       1 1 2     2
V     |                                                                                                   33        1 1
A  64 +                                                                                                  4 3 3        11
L     |                                                                                                    4 3 3       1    1
      |                                                                                                        3 3          1
      |                                                                                                          4  4
   56 +                                                                                                          3  3   4
      |                                                                                                             3  34   4
      |                                                                                                                33
      |                                                                                                                 3   3
   48 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 17 obs hidden.

                                                               OZONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        0.12 PPM         = 2
                                                        0.5 PPM          = 3
                                                        1.0 PPM          = 4

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

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

      |
      |
  100 + 1                                                                    1     24       3
      |
      |                                                                      1      44  1   3     3
      |                                                                            2 4  14  1    23         3
   95 +
      |                                                                                     11   2    2     33
      |                                                                                  4   11       2 2
      |                                                                                                      33
   90 +                                                                                       1  14     22    3  3
      |
P     |                                                                                          14    1 2     2 33
E     |                                                                                                1 4  1  2  4 2
R  85 +                                                                                                           33
C     |                                                                                                           4 4
E     |                                                                                                     11
N     |                                                                                                            3 3
T  80 +                                                                                                      11     22      4
      |                                                                                                              3 3
S     |                                                                                                       11     2 23
U     |                                                                                                        1  1    2  2
R  75 +
V     |                                                                                                                   2 2
I     |                                                                                                           1 1   3 3
V     |
A  70 +                                                                                                             11
L     |                                                                                                                   3 3
      |                                                                                                              11
      |
   65 +
      |                                                                                                               1   1
      |
      |
   60 +
      |
      |                                                                                                                   1 1
      |
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.