https://ntp.niehs.nih.gov/go/4556

TDMS Study 05185-03 Pathology Tables


NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: IITRI                                               ISOBUTYL NITRITE (IBN)                                DATE: 05/20/95       
EXPERIMENT: 05185 TEST: 03                                                                                     TIME: 11:03:25       
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: 03                                                                                     TIME: 11:03:25      
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 RATS
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 29     CENSORED DEATHS 10   TERMINAL 17        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      415   427   495   498   525   532   533   563   583   611                 |
 |      617   624   631   639   639   640   641   644   654   665                 |
 |      666   666   666   667   681   684   692   695   726                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 37.5 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 23     CENSORED DEATHS 10   TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      353   436   471   551   555   568   576   636   645   645                 |
 |      646   651   663   672   675   682   695   695   700   701                 |
 |      702   718   720                                                           |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 75 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 9      CENSORED DEATHS 11   TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      540   552   606   631   667   684   703   712   719                       |
 |  CENSORED DEATHS                                                               |
 |      200   456   456   456   456   456   456   456   456   456                 |
 |      456                                                                       |
 |                                                                                |
 ==================================================================================
                              ISOBUTYL NITRITE (IBN)
                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 150 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 18     CENSORED DEATHS 10   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      330   523   564   582   589   604   610   611   611   636                 |
 |      640   647   667   699   717   721   722   728                             |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================
                              ISOBUTYL NITRITE (IBN)
                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       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    |   100.0 100.0 100.0 100.0  98.2  96.4  85.5  81.1  57.0  37.3      |
 |           |                                                                    |
 |           |                                                                    |
 |37.5 PPM   |   100.0 100.0 100.0  98.2  98.2  94.2  94.2  85.5  72.3  50.4      |
 |           |                                                                    |
 |           |                                                                    |
 |75 PPM     |   100.0 100.0 100.0 100.0 100.0 100.0  97.8  95.6  91.1  80.0      |
 |           |                                                                    |
 |           |                                                                    |
 |150 PPM    |   100.0 100.0 100.0  98.2  98.2  98.2  96.0  87.3  74.2  61.1      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      37.5 PPM     75 PPM       150 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       37.3%        50.4%        80.0%        61.1%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.009N     P=0.152N     P<0.001      P=0.029N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       611.0        624.2        646.0        622.3    |
 |NATURAL DEATHS (C)      |       (14.9)       (20.2)       (22.6)       (22.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       619.1        637.2        657.5        645.9    |
 |(STANDARD ERROR)        |       (14.6)       (15.4)       (16.5)       (15.2)   |
 |                        |                                                       |
 ==================================================================================
       (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 RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 17     CENSORED DEATHS 10   TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      464   516   526   602   604   640   640   641   646   652                 |
 |      658   666   668   671   702   720   721                                   |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 37.5 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 10     CENSORED DEATHS 11   TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      378   477   624   645   648   659   672   686   720   729                 |
 |  CENSORED DEATHS                                                               |
 |      176   457   457   457   457   457   457   457   457   457                 |
 |      457                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 75 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 15     CENSORED DEATHS 10   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      316   377   504   604   610   636   647   650   653   674                 |
 |      686   705   708   726   730                                               |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================
                              ISOBUTYL NITRITE (IBN)
                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 150 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 13     CENSORED DEATHS 10   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      234   394   483   500   533   608   617   622   630   674                 |
 |      681   696   705                                                           |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================
                              ISOBUTYL NITRITE (IBN)
                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       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    |   100.0 100.0 100.0 100.0 100.0  97.8  93.5  89.1  76.1  63.0      |
 |           |                                                                    |
 |           |                                                                    |
 |37.5 PPM   |   100.0 100.0 100.0 100.0  98.2  96.0  96.0  96.0  87.0  78.1      |
 |           |                                                                    |
 |           |                                                                    |
 |75 PPM     |   100.0 100.0 100.0  98.2  96.4  96.4  94.2  92.0  81.1  67.9      |
 |           |                                                                    |
 |           |                                                                    |
 |150 PPM    |   100.0 100.0  98.2  98.2  96.4  94.2  89.9  89.9  81.1  72.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      37.5 PPM     75 PPM       150 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       63.0%        78.1%        67.9%        72.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.783N     P=0.167N     P=0.764N     P=0.573N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       631.6        623.8        615.1        567.5    |
 |NATURAL DEATHS (C)      |       (17.2)       (35.1)       (31.9)       (38.0)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       652.9        654.3        652.1        645.3    |
 |(STANDARD ERROR)        |       (14.6)       (17.6)       (16.3)       (17.2)   |
 |                        |                                                       |
 ==================================================================================
       (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=RATS SEX=MALE -------------------------------------------------------
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.
      |
      |
  100 + 1                                                    4  2         1                   3
      |                                                      4  2         11 2     2  1    4  33
      |                                                                            2  11   4   2 4  4   3
      |                                                                                1   1   22   4 4 3   3
   90 +                                                                                    11   2 2   4 4   3     3 3
      |                                                                                     11    22    44          3  3
P     |                                                                                      1   1 2        2          33
E     |                                                                                          1  1       2 2         33
R  80 +                                                                                             1    11 4            3  3
C     |                                                                                                   11444
E     |                                                                                                    11 2  24
N     |                                                                                                     11   22   4
T  70 +                                                                                                           22  4  4
      |                                                                                                            22
S     |                                                                                                             2 2  44
U     |                                                                                                      1 1
R  60 +                                                                                                        1 1    22  4 4
V     |                                                                                                          11
I     |                                                                                                                2 2
V     |
A  50 +                                                                                                                  2  2
L     |                                                                                                           1 1
      |                                                                                                             11
      |                                                                                                              11
   40 +                                                                                                               1   1
      |                                                                                                                   1 1
      |
      |
   30 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110
                                                                   WEEK
NOTE: 13 obs hidden.
                                                       ISOBUTYL NITRITE (IBN)
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        37.5 PPM         = 2
                                                        75 PPM           = 3
                                                        150 PPM          = 4
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.
      |
      |
  100 + 1                                    4             3       2              1
      |                                      4             3       2   4            2
      |                                                                           1      1
      |                                                            3   4            2  3 1  1              2
   95 +
      |                                                                             4  3    1          13  2  2
      |                                                                                4     4          33
      |                                                                                                11
P  90 +                                                                                      4          43  3
E     |                                                                                                 1    12  2
R     |                                                                                                 4 4 3 3  22
C     |
E  85 +                                                                                                           2 2
N     |                                                                                                   44  33
T     |                                                                                                      11     2    2
      |                                                                                                    4   3   3
S  80 +                                                                                                       11         2  2
U     |                                                                                                            33
R     |                                                                                                                     2
V     |                                                                                                        1  1 3 43
I  75 +                                                                                                               433
V     |
A     |                                                                                                                43 3 4
L     |
   70 +                                                                                                           1    1  3 3
      |
      |                                                                                                                1 1  3
      |
   65 +
      |
      |                                                                                                                  1  1
      |
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110
                                                                   WEEK
NOTE: 11 obs hidden.