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TDMS Study 05092-03 Pathology Tables

TP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                  O-NITROANISOLE                                    DATE: 04/11/97       
EXPERIMENT: 05092 TEST: 03                                                                                     TIME: 14:59:55       
TEST TYPE:  SPECIAL STUDY                       CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-45038                              ROUTE: DOSED FEED                                              NTP C#: 60388B       
PATHOLOGIST: R. THOMPSON                                                                                       CAS: 0091-23-6       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            Core Animals                                                            
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       EXCLUDE 002    0.0%     3 SSAC                                                               
                                       EXCLUDE 003    0.0%     6 SSAC                                                               
                                       EXCLUDE 004    0.0%     9 SSAC                                                               
                                       EXCLUDE 005    0.0%     15 SSAC                                                              
                                       EXCLUDE 007    0.0%     3 SSAC                                                               
                                       EXCLUDE 008    0.0%     6 SSAC                                                               
                                       EXCLUDE 009    0.0%     9 SSAC                                                               
                                       EXCLUDE 010    0.0%     15 SSAC                                                              
                                       EXCLUDE 012    1.80%     3 SSAC                                                              
                                       EXCLUDE 013    1.80%     6 SSAC                                                              
                                       EXCLUDE 014    1.80%     9 SSAC                                                              
                                       EXCLUDE 015    1.80%    15 SSAC                                                              
                                       EXCLUDE 017    1.80%   3 SSAC                                                                
                                       EXCLUDE 018    1.80%   6 SSAC                                                                
                                       EXCLUDE 019    1.80%   9 SSAC                                                                
                                       EXCLUDE 020    1.80%   15 SSAC                                                               
                                       EXCLUDE 022    0.600%  3 SSAC                                                                
                                       EXCLUDE 023    0.600%  6 SSAC                                                                
                                       EXCLUDE 024    0.600%  9 SSAC                                                                
                                       EXCLUDE 025    0.600%  15 SSAC                                                               
                                       EXCLUDE 027    0.600%  3 SSAC                                                                
                                       EXCLUDE 028    0.600%  6 SSAC                                                                
                                       EXCLUDE 029    0.600%  9 SSAC                                                                
                                       EXCLUDE 030    0.600%  15 SSAC                                                               
                                       EXCLUDE 031    SENTINEL                                                                      
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Southern Research Inst                                  O-NITROANISOLE                                    DATE: 04/11/97      
EXPERIMENT: 05092 TEST: 03                                                                                     TIME: 14:59:55      
TEST TYPE:  SPECIAL STUDY                       CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-45038                              ROUTE: DOSED FEED                                              NTP C#: 60388B      
PATHOLOGIST: R. THOMPSON                     S. EUSTIS                                                         CAS: 0091-23-6      
                                  O-NITROANISOLE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 20     UNCENSORED DEATHS 7      CENSORED DEATHS 0    TERMINAL 13        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      564   582   590   639   648   701   707                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.600%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 20     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 1         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      207   275   351   413   423   429   434   457   480   512                 |
 |      582   612   617   618   636   639   646   648   680                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.80%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 20     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      158   211   217   219   228   238   242   248   249   254                 |
 |      256   266   268   277   277   292   298   298   300   335                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  O-NITROANISOLE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   728 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0.0%       |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  85.0  75.0  65.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.600%     |   100.0 100.0  95.0  85.0  75.0  55.0  50.0  45.0  10.0   5.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1.80%      |   100.0  95.0  35.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                0.0%             0.600%           1.80%         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       65.0%             5.0%             0.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001          P<0.001          P<0.001       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       633.0            508.4            256.6         |
 |NATURAL DEATHS (C)      |       (21.6)           (31.7)           ( 8.9)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       694.8            519.4            256.6         |
 |(STANDARD ERROR)        |       (12.6)           (32.0)           ( 8.9)        |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                  O-NITROANISOLE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 20     UNCENSORED DEATHS 6      CENSORED DEATHS 0    TERMINAL 14        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      103   421   590   648   662   679                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.600%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 20     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 4         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      311   359   421   421   424   452   476   477   504   552                 |
 |      601   632   639   639   662   668                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.80%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 20     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      48    219   221   239   247   248   268   268   284   303                 |
 |      307   307   309   324   327   333   336   340   408   425                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  O-NITROANISOLE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   728 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0.0%       |   100.0  95.0  95.0  95.0  90.0  90.0  90.0  85.0  75.0  70.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.600%     |   100.0 100.0 100.0  90.0  75.0  60.0  55.0  45.0  25.0  20.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1.80%      |    95.0  95.0  60.0  10.0   0.0   0.0   0.0   0.0   0.0   0.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                0.0%             0.600%           1.80%         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       70.0%            20.0%             0.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001          P=0.002          P<0.001       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       517.2            514.9            288.1         |
 |NATURAL DEATHS (C)      |       (91.4)           (28.7)           (17.6)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       664.8            557.5            288.1         |
 |(STANDARD ERROR)        |       (33.9)           (30.0)           (17.6)        |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                           O-NITROANISOLE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0.0%             = 1
                                                        0.600%           = 2
                                                        1.80%            = 3

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

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

      |
      |
  100 + 1                        3       2                                                       1
      |
      |                          3       23         2                                            1  1
      |
   90 +                                             2           2                                   1 1
      |
      |                                   33                    2        2                            1      1
      |
   80 +                                    33                            2 2                                 11
      |
      |                                     33                             22                                 1        1
      |
P  70 +                                      3 3
E     |
R     |                                        33                           2    2                                     1  1
C     |
E  60 +                                                                          2  2
N     |
T     |                                         33                                  2    2
      |
S  50 +                                                                                  2          2
U     |
R     |                                          33                                                 2    2
V     |
I  40 +                                           33                                                     22
V     |
A     |                                            33
L     |
   30 +                                                                                                   2 2
      |
      |                                             3 3                                                     22
      |
   20 +                                               33                                                     22
      |
      |
      |
   10 +                                                                                                       2     2
      |
      |                                                3     3                                                      2     2
      |
    0 +                                                      3
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 2 obs hidden.
                                                           O-NITROANISOLE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0.0%             = 1
                                                        0.600%           = 2
                                                        1.80%            = 3

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

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

      |
      |
  100 + 1       3        1                                2
      |
      |         3        1                 3              2      2         1
      |
   90 +                                                          2         1                          1
      |
      |                                    3   3                                                      1       1
      |
   80 +                                        33                                                             1  1
      |
      |                                                                    2    2                                1 1
      |
P  70 +                                         3  3                            2  2                               1      1
E     |
R     |                                                                            22
C     |
E  60 +                                            3 3                              2  2
N     |
T     |                                              3  3                              2       2
      |
S  50 +                                                                                        2       2
U     |
R     |                                                                                                2    2
V     |
I  40 +                                                 3 3                                                 22
V     |
A     |                                                   3 3
L     |
   30 +                                                                                                      2   2
      |
      |                                                     33                                                   22
      |
   20 +                                                                                                           2       2
      |
      |                                                      33
      |
   10 +                                                       3          3
      |
      |                                                                  3 3
      |
    0 +                                                                    3
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 3 obs hidden.