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TDMS Study 88034-05 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Battelle Northwest                                        DATE: 05/08/95   
EXP: 88034                          OZONE                      TIME: 21:57:43   
TEST: 05              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC 30-MONTH ROUTE: RESPIRATORY EXPOSURE WHOLE  NTP C#: 88034B   
CONT: N01-ES-95239                                             CAS: 10028-15-6  
PATHOLOGIST: S. GRUMBEIN                                                        
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REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


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TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Battelle Northwest                                        DATE: 05/08/95  
EXP: 88034                          OZONE                      TIME: 21:57:43  
TEST: 05              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC 30-MONTH ROUTE: RESPIRATORY EXPOSURE WHOLE  NTP C#: 88034B  
CONT: N01-ES-95239                                             CAS: 10028-15-6 
PATHOLOGIST: S. GRUMBEIN                                                       

                                       OZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 874 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 50     CENSORED DEATHS 6    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      467   468   481   484   485   521   539   544   580   580                 |
 |      580   583   585   585   586   591   591   598   599   600                 |
 |      610   615   621   625   632   636   651   661   663   663                 |
 |      663   666   669   670   674   674   681   683   691   705                 |
 |      705   708   718   722   733   761   766   793   797   830                 |
 |  CENSORED DEATHS                                                               |
 |      623   623   623   623   623   623                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 50     CENSORED DEATHS 6    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      219   345   346   384   401   411   419   433   439   495                 |
 |      515   516   521   524   525   531   548   571   581   581                 |
 |      586   601   605   607   608   621   623   628   636   642                 |
 |      648   650   663   666   670   674   681   684   695   699                 |
 |      701   705   719   719   722   733   735   755   775   847                 |
 |  CENSORED DEATHS                                                               |
 |      623   623   623   623   623   623                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.0 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 49     CENSORED DEATHS 6    TERMINAL 1         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      342   383   419   453   488   524   536   539   549   557                 |
 |      567   569   579   581   608   614   616   618   619   621                 |
 |      632   643   650   653   663   666   671   691   701   705                 |
 |      705   708   716   728   728   737   737   741   747   751                 |
 |      754   756   756   760   761   761   779   817   825                       |
 |  CENSORED DEATHS                                                               |
 |      623   623   623   623   623   623                                         |
 |                                                                                |
 ==================================================================================

                                       OZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 874 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   874 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0  91.1  85.7  64.3  41.5   0.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5 PPM    |   100.0 100.0  98.2  94.6  87.5  83.9  71.4  58.9  38.3   0.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1.0 PPM    |   100.0 100.0 100.0  98.2  94.6  92.9  85.7  75.0  53.6   2.1      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                CONTROL          0.5 PPM          1.0 PPM       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|        0.0%             0.0%             2.1%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.124N         P=0.565          P=0.175N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       634.7            592.1            647.4         |
 |NATURAL DEATHS (C)      |       (12.2)           (18.2)           (15.9)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       633.4            595.4            648.9         |
 |(STANDARD ERROR)        |       (10.9)           (16.3)           (14.5)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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 RATS
                       FIRST TERMINAL SACRIFICE AT 874 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 44     CENSORED DEATHS 6    TERMINAL 6         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      31    406   417   434   467   494   554   556   557   566                 |
 |      577   581   581   604   627   631   635   635   646   649                 |
 |      652   659   678   684   691   691   696   708   718   719                 |
 |      722   723   731   731   747   747   748   758   760   783                 |
 |      789   790   827   842                                                     |
 |  CENSORED DEATHS                                                               |
 |      623   623   623   623   623   623                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 44     CENSORED DEATHS 6    TERMINAL 6         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      287   452   468   509   513   571   579   580   585   598                 |
 |      616   636   636   678   682   691   699   710   721   723                 |
 |      733   733   738   739   756   756   767   775   775   778                 |
 |      793   803   803   810   817   817   824   827   830   838                 |
 |      842   842   849   859                                                     |
 |  CENSORED DEATHS                                                               |
 |      623   623   623   623   623   623                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.0 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 43     CENSORED DEATHS 6    TERMINAL 7         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      285   467   483   486   536   551   554   559   566   580                 |
 |      614   632   635   643   663   666   670   670   673   682                 |
 |      685   695   699   705   705   713   714   721   733   733                 |
 |      744   753   758   761   775   775   793   800   811   817                 |
 |      831   848   861                                                           |
 |  CENSORED DEATHS                                                               |
 |      623   623   623   623   623   623                                         |
 |                                                                                |
 ==================================================================================

                                       OZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 874 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   874 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |    98.2  98.2  98.2  98.2  94.6  91.1  89.3  75.0  58.3  12.5      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5 PPM    |   100.0 100.0 100.0  98.2  98.2  94.6  91.1  82.1  76.2  12.4      |
 |           |                                                                    |
 |           |                                                                    |
 |1.0 PPM    |   100.0 100.0 100.0  98.2  98.2  94.6  91.1  82.1  72.1  14.4      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                CONTROL          0.5 PPM          1.0 PPM       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       12.5%            12.4%            14.4%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.406N         P=0.126N         P=0.441N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       641.9            705.4            675.5         |
 |NATURAL DEATHS (C)      |       (21.5)           (19.2)           (17.9)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       664.7            714.6            694.7         |
 |(STANDARD ERROR)        |       (19.5)           (17.2)           (16.6)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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
                                                        0.5 PPM          = 2
                                                        1.0 PPM          = 3

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

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

             |
             |
         100 +  1                       2            3            1
             |                          2            32  3   3    1 1
             |                                        2  2   3   3  11
             |                                           2  2    3   3
          90 +                                              22       1  1 1
             |                                               2 2          11
             |                                                 2     2    313 1
             |                                                       2  2   33
          80 +                                                               311
             |                                                          2     3
             |                                                                3  3
             |                                                          22 2   1133
       P  70 +                                                             2  2 1133
       E     |                                                                2
       R     |                                                                22 1133
       C     |                                                                 2 2  33
       E  60 +                                                                   211133
       N     |                                                                      1 33
       T     |                                                                   2 2   3
             |                                                                     21 133
       S  50 +                                                                      2 113 3
       U     |                                                                      22    3 3
       R     |                                                                       22
       V     |                                                                         11
       I  40 +                                                                        22    33
       V     |                                                                         22    33
       A     |                                                                          11
       L     |                                                                           22   3 3
          30 +                                                                           11
             |                                                                            22
             |                                                                            1 1   3
             |                                                                             22   33
          20 +                                                                              11
             |                                                                              21
             |                                                                               11  33
             |                                                                               211
          10 +                                                                                 1  1
             |                                                                                 2 2113 1 3
             |                                                                                   2 2    33
             |                                                                                     2  1  1 2  3
           0 +                                                                                           1 2
             |
             ---+--------------+--------------+--------------+--------------+--------------+--------------+--------------+--
                0             20             40             60             80             100            120            140

                                                                   WEEK

NOTE: 41 obs hidden.

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

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

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

             |
             |
         100 +  1   1                          2
             |      1                          2            11   22 3
             |                                               1 1  2 33 2
             |                                                 1  1  3 22 3
          90 +                                                    1  1  2 331 2
             |
             |                                                              1122 2
             |                                                               11  22
          80 +                                                                    2 2
             |                                                                1  1
       P     |                                                                   1  13 3 22
       E     |                                                                      1  33 2
       R  70 +                                                                            22
       C     |                                                                      1 1    2 2
       E     |                                                                          333  22
       N     |                                                                        11      22
       T  60 +                                                                         1  33
             |                                                                         1 11    22
       S     |                                                                            133
       U     |                                                                              33  22
       R  50 +                                                                            11     2 2
       V     |                                                                             1 1     2
       I     |                                                                               1 3
       V     |                                                                               11    22
       A  40 +                                                                                 333  2 2
       L     |                                                                                11 33
             |                                                                                        22
             |                                                                                 11 33   22
          30 +                                                                                     3  3 22
             |                                                                                  1 1   3  2
             |                                                                                        33
             |                                                                                    1 1  3322
          20 +                                                                                      11  3322
             |                                                                                       1   1 22
             |                                                                                           1 12 3
             |                                                                                             12 1
          10 +
             |
             ---+--------------+--------------+--------------+--------------+--------------+--------------+--------------+--
                0             20             40             60             80             100            120            140

                                                                   WEEK

NOTE: 51 obs hidden.