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TDMS Study 05185-04 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: IITRI                                               ISOBUTYL NITRITE (IBN)                                DATE: 05/20/95       
EXPERIMENT: 05185 TEST: 04                                                                                     TIME: 11:45:35       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01 ES 65143                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 61052B       
PATHOLOGIST: RICHARD LONG                                                                                      CAS: 542-56-3        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    


               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: IITRI                                               ISOBUTYL NITRITE (IBN)                                DATE: 05/20/95      
EXPERIMENT: 05185 TEST: 04                                                                                     TIME: 11:45:35      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01 ES 65143                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 61052B      
PATHOLOGIST: RICHARD LONG                                                                                      CAS: 542-56-3       

                              ISOBUTYL NITRITE (IBN)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 725 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 11     CENSORED DEATHS 12   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      136   455   479   509   512   529   563   594   604   618                 |
 |      711                                                                       |
 |  CENSORED DEATHS                                                               |
 |      61    457   457   457   457   457   457   457   457   457                 |
 |      457   570                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 37.5 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 15     CENSORED DEATHS 10   TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      124   379   561   581   614   667   667   682   684   687                 |
 |      692   693   699   703   724                                               |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 75 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 15     CENSORED DEATHS 10   TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      307   408   484   557   558   558   564   579   583   614                 |
 |      619   647   662   681   701                                               |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================

                              ISOBUTYL NITRITE (IBN)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 725 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 150 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 9    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      96    296   300   316   443   534   541   552   553   556                 |
 |      558   558   575   588   625   640   668   692   693   718                 |
 |      724                                                                       |
 |  CENSORED DEATHS                                                               |
 |      100   235   457   457   457   457   457   457   457                       |
 |                                                                                |
 ==================================================================================

                              ISOBUTYL NITRITE (IBN)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 725 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   725 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0  98.3  98.3  98.3  98.3  94.6  88.4  82.1  80.0  77.9      |
 |           |                                                                    |
 |           |                                                                    |
 |37.5 PPM   |   100.0  98.3  98.3  98.3  96.7  96.7  96.7  92.6  90.6  70.5      |
 |           |                                                                    |
 |           |                                                                    |
 |75 PPM     |   100.0 100.0 100.0  98.3  96.7  94.7  94.7  82.6  74.5  70.5      |
 |           |                                                                    |
 |           |                                                                    |
 |150 PPM    |   100.0  98.3  98.3  93.2  93.2  91.4  87.5  73.5  69.6  59.6      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      37.5 PPM     75 PPM       150 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       77.9%        70.5%        70.5%        59.6%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.047      P=0.677      P=0.599      P=0.083  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       519.1        610.5        568.1        534.6    |
 |NATURAL DEATHS (C)      |       (44.1)       (41.4)       (26.9)       (35.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       628.9        651.7        641.1        608.5    |
 |(STANDARD ERROR)        |       (19.2)       (16.4)       (15.2)       (21.3)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                              ISOBUTYL NITRITE (IBN)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 19     CENSORED DEATHS 9    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      71    91    572   576   585   589   595   613   635   638                 |
 |      643   649   689   690   691   691   696   709   709                       |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 37.5 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 9      CENSORED DEATHS 9    TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      183   512   520   586   614   645   697   707   728                       |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 75 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 59     UNCENSORED DEATHS 14     CENSORED DEATHS 9    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      210   415   434   460   558   558   585   628   636   639                 |
 |      660   663   706   719                                                     |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458                       |
 |                                                                                |
 ==================================================================================

                              ISOBUTYL NITRITE (IBN)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 150 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 12     CENSORED DEATHS 11   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      71    114   485   494   583   603   625   646   692   716                 |
 |      721   724                                                                 |
 |  CENSORED DEATHS                                                               |
 |      65    458   458   458   458   458   458   458   458   458                 |
 |      458                                                                       |
 |                                                                                |
 ==================================================================================

                              ISOBUTYL NITRITE (IBN)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |    98.3  96.7  96.7  96.7  96.7  96.7  96.7  86.8  76.9  63.1      |
 |           |                                                                    |
 |           |                                                                    |
 |37.5 PPM   |   100.0 100.0  98.3  98.3  98.3  98.3  94.4  92.4  88.5  82.6      |
 |           |                                                                    |
 |           |                                                                    |
 |75 PPM     |   100.0 100.0  98.3  98.3  96.6  92.9  92.9  86.8  76.7  72.7      |
 |           |                                                                    |
 |           |                                                                    |
 |150 PPM    |    98.3  96.6  96.6  96.6  96.6  94.6  92.5  88.4  84.3  76.1      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      37.5 PPM     75 PPM       150 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       63.1%        82.6%        72.7%        76.1%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.452N     P=0.045N     P=0.494N     P=0.238N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       585.9        576.9        562.2        539.5    |
 |NATURAL DEATHS (C)      |       (42.2)       (55.6)       (37.3)       (64.6)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       643.0        665.5        648.1        634.9    |
 |(STANDARD ERROR)        |       (18.5)       (15.5)       (16.4)       (21.4)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                       ISOBUTYL NITRITE (IBN)
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        37.5 PPM         = 2
                                                        75 PPM           = 3
                                                        150 PPM          = 4

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

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

      |
      |
  100 + 1              4    2 1                         3
      |                4    2 1                        43            2   3      1
      |
      |                                                              2   3      1   13           2
   95 +                                                4   4                        13  1       32 2
      |                                                    4                  4
      |                                                                                 11         2     2
      |                                                                       4              4           2        2
P  90 +                                                                                  1  144
E     |                                                                                     1   31
R     |                                                                                       44
C     |                                                                                          1 3  1           2 2
E  85 +                                                                                            33
N     |                                                                                        44     1 1
T     |                                                                                             3   131         22
      |
S  80 +                                                                                                  31             1
U     |                                                                                                   3   3
R     |                                                                                         4  4                    1 1
V     |                                                                                                       3  3   22
I  75 +                                                                                            44            3  3 22
V     |                                                                                             4      4
A     |                                                                                                             3  2  2
L     |                                                                                                    4 4
   70 +                                                                                                      4    4    3  2
      |
      |                                                                                                           4  4
      |
   65 +
      |                                                                                                              4   4
      |
      |                                                                                                                  44
   60 +                                                                                                                   4
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.

                                                       ISOBUTYL NITRITE (IBN)
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        37.5 PPM         = 2
                                                        75 PPM           = 3
                                                        150 PPM          = 4

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

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

      |
      |
  100 + 1           1                 2  3
      |             1 1    4          2  3                                3              2
      |
      |               1    4                                              3 3        4   2 2      1
   95 +                                                                     3    3   44    2      112
      |
      |                                                                          3    4         3  11    2
      |                                                                                             1 1
P  90 +                                                                                             4   42    2
E     |                                                                                         3   3   4  4  2       2
R     |
C     |                                                                                             3 1  1 3  4       22
E  85 +                                                                                                  1 31          2  2
N     |                                                                                                       4      4
T     |                                                                                                     11       4   42 2
      |                                                                                                      3   3
S  80 +
U     |                                                                                                      11
R     |                                                                                                       1      1   44
V     |                                                                                                          3     3  4 4
I  75 +                                                                                                                3 3
V     |
A     |                                                                                                                  3  3
L     |
   70 +
      |                                                                                                              11
      |                                                                                                               1 1
      |
   65 +
      |                                                                                                                 1   1
      |
      |
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 11 obs hidden.