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TDMS Study 05200-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                       NITROMETHANE                                     DATE: 04/04/96       
EXPERIMENT: 05200 TEST: 06                                                                                     TIME: 06:25:01       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-75189                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C61927       
PATHOLOGIST: R. MILLER                       R. RENNE                                                          CAS: 75-52-5         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Northwest                                       NITROMETHANE                                     DATE: 04/04/96      
EXPERIMENT: 05200 TEST: 06                                                                                     TIME: 06:25:01      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-75189                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C61927      
PATHOLOGIST: R. MILLER                       R. RENNE                                                          CAS: 75-52-5        
                                   NITROMETHANE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 734 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      441   449   490   503   503   534   545   576   581   609                 |
 |      623   653   653   653   653   665   701   714   731                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 188 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      320   448   479   484   578   646   659   665   679   707                 |
 |      721   721   728   731                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 375 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      331   377   436   498   520   534   541   563   576   581                 |
 |      581   592   645   655   679   693   705   707   726   733                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                   NITROMETHANE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 734 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 750 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      393   406   497   551   586   595   596   609   632   649                 |
 |      659   665   671   679   679   688   699   699   699   704                 |
 |      726                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                   NITROMETHANE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 734 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   734 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0  96.0  86.0  82.0  68.0  62.0      |
 |           |                                                                    |
 |           |                                                                    |
 |188 PPM    |   100.0 100.0 100.0  98.0  98.0  92.0  92.0  90.0  84.0  72.0      |
 |           |                                                                    |
 |           |                                                                    |
 |375 PPM    |   100.0 100.0 100.0  98.0  96.0  94.0  86.0  76.0  72.0  60.0      |
 |           |                                                                    |
 |           |                                                                    |
 |750 PPM    |   100.0 100.0 100.0 100.0  96.0  96.0  94.0  86.0  76.0  58.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      188 PPM      375 PPM      750 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       62.0%        72.0%        60.0%        58.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.519      P=0.321N     P=0.960      P=0.949  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       593.5        611.9        583.7        623.0    |
 |NATURAL DEATHS (C)      |       (20.4)       (34.6)       (25.5)       (20.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       680.6        699.8        673.9        687.4    |
 |(STANDARD ERROR)        |       (12.4)       (12.3)       (14.5)       (11.5)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                   NITROMETHANE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 734 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 2    TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      301   376   385   401   574   576   597   609   617   618                 |
 |      632   632   657   663   667   667   681   693   693   693                 |
 |      707   707   716                                                           |
 |  CENSORED DEATHS                                                               |
 |      436   436                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 188 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      345   357   416   426   441   534   555   564   569   569                 |
 |      579   581   637   639   646   653   656   663   665   693                 |
 |      693   731                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 375 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 1    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      69    498   548   568   572   602   608   609   631   637                 |
 |      637   646   653   665   665   679   680   693   693   716                 |
 |      721   727   733                                                           |
 |  CENSORED DEATHS                                                               |
 |      296                                                                       |
 |                                                                                |
 ==================================================================================
                                   NITROMETHANE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 734 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 750 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      51    426   503   553   603   632   638   657   687   699                 |
 |      706   716   721   729                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                   NITROMETHANE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 734 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   734 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0  98.0  92.0  92.0  92.0  85.7  71.1  52.3      |
 |           |                                                                    |
 |           |                                                                    |
 |188 PPM    |   100.0 100.0 100.0  96.0  94.0  90.0  88.0  76.0  62.0  56.0      |
 |           |                                                                    |
 |           |                                                                    |
 |375 PPM    |    98.0  98.0  98.0  98.0  98.0  98.0  96.0  87.8  69.4  53.1      |
 |           |                                                                    |
 |           |                                                                    |
 |750 PPM    |    98.0  98.0  98.0  98.0  98.0  96.0  94.0  90.0  84.0  72.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      188 PPM      375 PPM      750 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       52.3%        56.0%        53.1%        72.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.046N     P=1.000N     P=0.993N     P=0.056N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       602.7        573.3        619.6        594.4    |
 |NATURAL DEATHS (C)      |       (24.9)       (23.8)       (28.0)       (48.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       661.7        663.3        672.6        694.9    |
 |(STANDARD ERROR)        |       (16.0)       (15.4)       (16.9)       (15.9)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                            NITROMETHANE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        188 PPM          = 2
                                                        375 PPM          = 3
                                                        750 PPM          = 4

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

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

      |
      |
  104 +
      |
      | 1                                                  2 3         4     1
      |                                                    2 3     3   44    12 1
P  96 +                                                            3    4    32 1   214
E     |                                                                      3      2141       4
R     |                                                                              2 3   3   4   24
C     |                                                                                1   3 1     24 4       2
E  88 +                                                                                      11       44      2  2
N     |                                                                                       1  3 1   44
T     |                                                                                          3 3    4   4    2 2
      |                                                                                            1    1   4 4    2   2
S  80 +                                                                                                 1 1   4  4     2 2
U     |                                                                                            3  3   1    1
R     |                                                                                               3       3  44      22
V     |                                                                                                       33  44      2 2
I  72 +                                                                                                        3   3        2
V     |                                                                                                        1 1 3 3
A     |                                                                                                          1   341
L     |                                                                                                                11
   64 +                                                                                                                31 3 1
      |                                                                                                               44  3 1
      |                                                                                                                4  4 3
      |                                                                                                                   4 4
   56 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 14 obs hidden.
                                                            NITROMETHANE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        188 PPM          = 2
                                                        375 PPM          = 3
                                                        750 PPM          = 4

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

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

      |
  100 + 1        4 3                                   1       2
      |
      |          4 3                                   1       22  1       4           3
      |                                                         2  1 1    24           3       3
   95 +
      |                                                              1  1 22           4       3  3
      |                                                                 1  2 2                 4  1     4
      |
   90 +                                                                      2               2    11   34   4
      |
      |                                                                                      2  2  1   13   44
      |                                                                                         22     11    4 4
P  85 +
E     |                                                                                          22     1 1 3  4     4
R     |                                                                                                              44
C     |
E  80 +                                                                                           22      1 1         44
N     |
T     |                                                                                                     3 3        4 4
      |                                                                                            2        2
S  75 +                                                                                                     1 31
U     |                                                                                                     22 1 1       4  4
R     |                                                                                                      22             4
V     |                                                                                                          11
I  70 +                                                                                                       22 3 3
V     |
A     |                                                                                                           131
L     |                                                                                                        2 2
   65 +                                                                                                             11
      |
      |                                                                                                          2   2
      |                                                                                                              3   3
   60 +
      |                                                                                                              1 1
      |                                                                                                              2   33 2
      |                                                                                                                     2
   55 +                                                                                                                   3 3
      |                                                                                                                1 1
      |                                                                                                                  1  1
      |
   50 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 15 obs hidden.