https://ntp.niehs.nih.gov/go/12009

TDMS Study 60968-02 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                     ISOBUTYRALDEHYDE                                   DATE: 09/23/96       
EXPERIMENT: 60968 TEST: 02                                                                                     TIME: 16:35:24       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-95241                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 60968B       
PATHOLOGIST: S. GRUMBEIN                     GRUMBEIN, SONDRA                                                  CAS: 0078-84-2       
------------------------------------------------------------------------------------------------------------------------------------
                                                             CORE STUDY                                                             
               REASONS FOR REMOVAL:    ALL                                                                                          
               REMOVAL DATE RANGE:     ALL                                                                                          
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Northwest                                     ISOBUTYRALDEHYDE                                   DATE: 09/23/96      
EXPERIMENT: 60968 TEST: 02                                                                                     TIME: 16:35:24      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-95241                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 60968B      
PATHOLOGIST: S. GRUMBEIN                     GRUMBEIN, SONDRA                                                  CAS: 0078-84-2      
                                 ISOBUTYRALDEHYDE
                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      455   520   639   639   639   659   664   676   682   685                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 500 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      415   573   580   605   611   623   632   649   670   680                 |
 |      709   712   723                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      43    322   359   410   421   448   529   535   560   630                 |
 |      632   649   672   711   728                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                 ISOBUTYRALDEHYDE
                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 2000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      415   499   547   571   588   597   616   639   649   653                 |
 |      653   658   665   670   679   690   691   709   723   723                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                 ISOBUTYRALDEHYDE
                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   733 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  96.0  86.0  80.0      |
 |           |                                                                    |
 |           |                                                                    |
 |500 PPM    |   100.0 100.0 100.0 100.0  98.0  98.0  98.0  92.0  84.0  74.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1000 PPM   |    98.0  98.0  98.0  94.0  90.0  88.0  84.0  82.0  76.0  70.0      |
 |           |                                                                    |
 |           |                                                                    |
 |2000 PPM   |   100.0 100.0 100.0 100.0  98.0  98.0  96.0  88.0  74.0  60.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      500 PPM      1000 PPM     2000 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       80.0%        74.0%        70.0%        60.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.034      P=0.605      P=0.270      P=0.051  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       625.8        629.4        509.9        631.8    |
 |NATURAL DEATHS (C)      |       (24.2)       (22.5)       (47.0)       (17.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       711.6        706.1        666.1        692.5    |
 |(STANDARD ERROR)        |       ( 7.7)       ( 8.6)       (20.1)       ( 9.9)   |
 |                        |                                                       |
 ==================================================================================
       (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)
                                 ISOBUTYRALDEHYDE
                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 735 DAYS
                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 1    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      76    344   533   543   583   596   611   623   637   639                 |
 |      646   646   657   686   691   695   700   701   701   712                 |
 |      723                                                                       |
 |  CENSORED DEATHS                                                               |
 |      69                                                                        |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 500 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 1    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      93    527   546   595   611   611   621   623   636   663                 |
 |      681   686   691   695   702   712   731                                   |
 |  CENSORED DEATHS                                                               |
 |      603                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      537   547   554   577   581   609   611   631   633   645                 |
 |      653   665   674   713                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                 ISOBUTYRALDEHYDE
                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 735 DAYS
                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 2000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      415   415   483   611   652   653   653   653   653   665                 |
 |      681   682   702                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                 ISOBUTYRALDEHYDE
                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 735 DAYS
 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   735 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |    98.0  98.0  98.0  95.9  95.9  95.9  91.8  87.8  73.5  57.1      |
 |           |                                                                    |
 |           |                                                                    |
 |500 PPM    |   100.0  98.0  98.0  98.0  98.0  98.0  96.0  92.0  79.7  65.4      |
 |           |                                                                    |
 |           |                                                                    |
 |1000 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  90.0  76.0  72.0      |
 |           |                                                                    |
 |           |                                                                    |
 |2000 PPM   |   100.0 100.0 100.0 100.0  96.0  94.0  94.0  94.0  80.0  74.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      500 PPM      1000 PPM     2000 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       57.1%        65.4%        72.0%        74.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.103N     P=0.508N     P=0.225N     P=0.120N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       606.8        613.2        616.4        609.1    |
 |NATURAL DEATHS (C)      |       (32.4)       (35.4)       (14.0)       (28.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       667.8        690.9        701.8        702.3    |
 |(STANDARD ERROR)        |       (20.2)       (14.5)       ( 8.5)       (10.6)   |
 |                        |                                                       |
 ==================================================================================
       (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)
                                                          ISOBUTYRALDEHYDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        500 PPM          = 2
                                                        1000 PPM         = 3
                                                        2000 PPM         = 4
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.
      |
      |
  100 + 1       3                                                         2     1
      |
      |         3                                          3              2     1      4   1      2
      |                                                    3     3                     4   1   4  22         1
   95 +
      |                                                          3       3                     4  42    2
      |                                                                  3 3                      4 4   22
      |
P  90 +                                                                    3  3                     4  4 22  1   1
E     |
R     |                                                                       3             3          4 42 2
C     |                                                                                     33           4  242  1 1
E  85 +
N     |                                                                                      3  3            42   211
T     |                                                                                         3          3  44  2 2
      |
S  80 +                                                                                                    33       1   2   1
U     |
R     |                                                                                                     3 3
V     |                                                                                                       34 43     2 2
I  75 +
V     |                                                                                                          43     3 2 2
A     |                                                                                                           44    3 3
L     |
   70 +                                                                                                            4 4    3 3
      |
      |
      |                                                                                                              4  4
   65 +
      |                                                                                                                 4 4
      |
      |
   60 +                                                                                                                   4 4
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110
                                                                   WEEK
NOTE: 8 obs hidden.
                                                          ISOBUTYRALDEHYDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        500 PPM          = 2
                                                        1000 PPM         = 3
                                                        2000 PPM         = 4
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.
      |
      |
  100 + 1           1  2                                                  4                  3
      |
      |             1  2                                       1                            23 3
      |                                                        1          4         4       21233
   95 +
      |                                                                             4        11 3  3  2  4
      |                                                                                               2  2     4
      |                                                                                       1     1
   90 +                                                                                            31  13
      |
P     |                                                                                                1312
E     |                                                                                                  11 3
R  85 +
C     |                                                                                                   1 1
E     |                                                                                                     3 34 4
N     |                                                                                                     11   2
T  80 +                                                                                                      113 2  2
      |
S     |                                                                                                        3 3
U     |                                                                                                          3 322 4
R  75 +                                                                                                       11
V     |                                                                                                        1   312243   4
I     |                                                                                                                 3   3
V     |                                                                                                             1122
A  70 +                                                                                                              1122
L     |
      |                                                                                                                 2   2
      |
   65 +                                                                                                               11    2
      |
      |
      |                                                                                                                11
   60 +
      |                                                                                                                 1 1
      |                                                                                                                   1 1
      |
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110
                                                                   WEEK
NOTE: 15 obs hidden.