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TDMS Study 05092-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                  O-NITROANISOLE                                    DATE: 04/15/97       
EXPERIMENT: 05092 TEST: 03                                                                                     TIME: 12:00:15       
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       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                              15 SSAC                                                               
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       EXCLUDE 001    0.0%                                                                          
                                       EXCLUDE 002    0.0%     3 SSAC                                                               
                                       EXCLUDE 003    0.0%     6 SSAC                                                               
                                       EXCLUDE 004    0.0%     9 SSAC                                                               
                                       EXCLUDE 006    0.0%                                                                          
                                       EXCLUDE 007    0.0%     3 SSAC                                                               
                                       EXCLUDE 008    0.0%     6 SSAC                                                               
                                       EXCLUDE 009    0.0%     9 SSAC                                                               
                                       EXCLUDE 011    1.80%                                                                         
                                       EXCLUDE 012    1.80%     3 SSAC                                                              
                                       EXCLUDE 013    1.80%     6 SSAC                                                              
                                       EXCLUDE 014    1.80%     9 SSAC                                                              
                                       EXCLUDE 016    1.80%                                                                         
                                       EXCLUDE 017    1.80%   3 SSAC                                                                
                                       EXCLUDE 018    1.80%   6 SSAC                                                                
                                       EXCLUDE 019    1.80%   9 SSAC                                                                
                                       EXCLUDE 021    0.600%                                                                        
                                       EXCLUDE 022    0.600%  3 SSAC                                                                
                                       EXCLUDE 023    0.600%  6 SSAC                                                                
                                       EXCLUDE 024    0.600%  9 SSAC                                                                
                                       EXCLUDE 026    0.600%                                                                        
                                       EXCLUDE 027    0.600%  3 SSAC                                                                
                                       EXCLUDE 028    0.600%  6 SSAC                                                                
                                       EXCLUDE 029    0.600%  9 SSAC                                                                
                                       EXCLUDE 031    SENTINEL                                                                      
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Southern Research Inst                                  O-NITROANISOLE                                    DATE: 04/15/97      
EXPERIMENT: 05092 TEST: 03                                                                                     TIME: 12:00:15      
TEST TYPE:  SPECIAL STUDY                       CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-45038                              ROUTE: DOSED FEED                                              NTP C#: 60388B      
PATHOLOGIST: R. THOMPSON                                                                                       CAS: 0091-23-6      
                                  O-NITROANISOLE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 99999 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0.0%     15 SSAC                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 1      CENSORED DEATHS 9    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      410                                                                       |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   456   456   456   456                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.600%  15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 7      CENSORED DEATHS 3    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      305   329   329   364   424   428   430                                   |
 |  CENSORED DEATHS                                                               |
 |      455   456   456                                                           |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 1.80%    15 SSAC                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      210   216   218   233   236   249   262   287   298   319                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  O-NITROANISOLE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 99999 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   1E5 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0.0%       |   100.0 100.0 100.0 100.0  90.0  90.0  90.0  90.0  90.0  90.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 |0.600%     |   100.0 100.0 100.0  60.0  50.0  30.0  30.0  30.0  30.0  30.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 |1.80%      |   100.0 100.0  30.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                0.0%             0.600%           1.80%         |
 |                                15 SSAC          15 SSAC          15 SSAC       |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       90.0%            30.0%             0.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001          P=0.020          P<0.001       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       410.0            372.7            252.8         |
 |NATURAL DEATHS (C)      |       (  . )           (20.4)           (11.9)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       450.9            397.6            252.8         |
 |(STANDARD ERROR)        |       ( 4.5)           (18.8)           (11.9)        |
 |                        |                                                       |
 ==================================================================================
                                    

       (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 99999 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0.0%     15 SSAC                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 2      CENSORED DEATHS 8    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      408   413                                                                 |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   456   456   456                             |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.600%  15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 1.80%   15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      84    265   281   298   309   317   336   345   345   346                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  O-NITROANISOLE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 99999 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   1E5 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0.0%       |   100.0 100.0 100.0 100.0  80.0  80.0  80.0  80.0  80.0  80.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 |0.600%     |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 |1.80%      |    90.0  90.0  80.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                0.0%             0.600%           1.80%         |
 |                                15 SSAC          15 SSAC          15 SSAC       |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       80.0%           100.0%             0.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001          P=0.456N         P<0.001       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       410.5               .             292.6         |
 |NATURAL DEATHS (C)      |       ( 2.5)           (  . )           (24.8)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       446.4            455.5            292.6         |
 |(STANDARD ERROR)        |       ( 6.0)           ( 0.2)           (24.8)        |
 |                        |                                                       |
 ==================================================================================
                                    

       (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%     15 SSAC = 1
                                                        0.600%  15 SSAC  = 2
                                                        1.80%    15 SSAC = 3

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

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

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

                                                                   WEEK

NOTE: 2 obs hidden.
                                                           O-NITROANISOLE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0.0%     15 SSAC = 1
                                                        0.600%  15 SSAC  = 2
                                                        1.80%   15 SSAC  = 3

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

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

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

                                                                   WEEK

NOTE: 2 obs hidden.