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TDMS Study 05093-01 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                  P-NITROANILINE                                    DATE: 10/23/97       
EXPERIMENT: 05093 TEST: 01                                                                                     TIME: 07:02:49       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-45038                              ROUTE: GAVAGE                                                  NTP C#: 60786B       
PATHOLOGIST: H. GILES                        S. EUSTIS                                                         CAS: 100-01-6        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    VEHICLE CONTROL                                                               
                                       INCLUDE 004    VEHICLE CONTROL                                                               
                                       INCLUDE 007    100MG/KG                                                                      
                                       INCLUDE 010    100MG/KG                                                                      
                                       INCLUDE 013    30 MG/KG                                                                      
                                       INCLUDE 016    30 MG/KG                                                                      
                                       INCLUDE 019    3 MG/KG                                                                       
                                       INCLUDE 022    3 MG/KG                                                                       
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Southern Research Inst                                  P-NITROANILINE                                    DATE: 10/23/97      
EXPERIMENT: 05093 TEST: 01                                                                                     TIME: 07:02:49      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-45038                              ROUTE: GAVAGE                                                  NTP C#: 60786B      
PATHOLOGIST: H. GILES                        S. EUSTIS                                                         CAS: 100-01-6       
                                  P-NITROANILINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      8     518   527   540   575   611   619   640   667   692                 |
 |      721   721   724   725   725   725   725                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 3 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      399   525   536   555   570   571   584   602   611   654                 |
 |      654   659   681   681   701   701   714   725                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 30 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 1    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      445   478   501   570   591   599   631   680   690   701                 |
 |      701   725   725                                                           |
 |  CENSORED DEATHS                                                               |
 |      7                                                                         |
 |                                                                                |
 ==================================================================================
                                  P-NITROANILINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 100MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      298   477   563   571   649   656   701   716   724   725                 |
 |      725                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  P-NITROANILINE

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

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |    98.0  98.0  98.0  98.0  98.0  98.0  92.0  90.0  84.0  66.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |3 MG/KG    |   100.0 100.0 100.0 100.0  98.0  98.0  94.0  84.0  76.0  64.0      |
 |           |                                                                    |
 |           |                                                                    |
 |30 MG/KG   |   100.0 100.0 100.0 100.0 100.0  95.9  93.9  87.8  85.7  73.5      |
 |           |                                                                    |
 |           |                                                                    |
 |100MG/KG   |   100.0 100.0 100.0  98.0  98.0  96.0  96.0  92.0  88.0  78.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      3 MG/KG      30 MG/KG     100MG/KG |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       66.0%        64.0%        73.5%        78.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.137N     P=0.846      P=0.599N     P=0.270N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       615.5        617.9        618.2        618.6    |
 |NATURAL DEATHS (C)      |       (42.2)       (19.8)       (26.9)       (40.5)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       690.4        689.0        685.8        704.7    |
 |(STANDARD ERROR)        |       (16.0)       (10.3)       (16.9)       (10.8)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                  P-NITROANILINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 1    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      298   373   423   483   534   536   570   599   606   620                 |
 |      631   662   680   700   701   701   701   701   725   725                 |
 |  CENSORED DEATHS                                                               |
 |      2                                                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 3 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 0    TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      341   478   553   581   606   653   667   700   719                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 30 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 2    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      424   448   465   484   560   654   655   667   672   692                 |
 |      703   716   716   720   723   725                                         |
 |  CENSORED DEATHS                                                               |
 |      11    17                                                                  |
 |                                                                                |
 ==================================================================================
                                  P-NITROANILINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 100MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 1    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      402   477   501   542   634   651   665   667   681   692                 |
 |      708   711   716   723   724   725   725                                   |
 |  CENSORED DEATHS                                                               |
 |      347                                                                       |
 |                                                                                |
 ==================================================================================
                                  P-NITROANILINE

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

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0  98.0  93.9  91.8  87.8  83.7  75.5  59.2      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |3 MG/KG    |   100.0 100.0 100.0  98.0  98.0  96.0  96.0  92.0  88.0  82.0      |
 |           |                                                                    |
 |           |                                                                    |
 |30 MG/KG   |   100.0 100.0 100.0 100.0  97.9  91.7  91.7  89.6  85.4  66.7      |
 |           |                                                                    |
 |           |                                                                    |
 |100MG/KG   |   100.0 100.0 100.0 100.0  98.0  95.9  91.8  91.8  85.7  65.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      3 MG/KG      30 MG/KG     100MG/KG |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       59.2%        82.0%        66.7%        65.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.773      P=0.026N     P=0.490N     P=0.528N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       598.5        588.7        626.5        643.8    |
 |NATURAL DEATHS (C)      |       (27.7)       (39.9)       (27.6)       (24.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       662.2        703.7        667.6        692.4    |
 |(STANDARD ERROR)        |       (19.6)       (10.3)       (22.0)       (12.2)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                           P-NITROANILINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        3 MG/KG          = 2
                                                        30 MG/KG         = 3
                                                        100MG/KG         = 4

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

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

      |
      |
  100 + 1 1                                            4               2      3
      |
      |   1                                            4               2      3     3    1 2
      |                                                                             3  3 1 212   4
   95 +
      |                                                                                3    121 243
      |                                                                                       1 2 21          4
      |                                                                                           3   3
P  90 +                                                                                            1  33 1    44
E     |
R     |                                                                                           2 2  3 11 3  4       4
C     |                                                                                             2  2  1 31      3  4 4
E  85 +
N     |                                                                                                2 2   1    1 33   44
T     |                                                                                                  2     2  1  1
      |                                                                                                              3 3
S  80 +                                                                                                              1   1
U     |
R     |                                                                                                        2 2     3  3 4
V     |                                                                                                          2  2    11
I  75 +
V     |                                                                                                                   3 3
A     |                                                                                                             2  2
L     |
   70 +
      |
      |                                                                                                                22
      |                                                                                                                 2 1 1
   65 +
      |                                                                                                                   2 2
      |
      |
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 9 obs hidden.
                                                           P-NITROANILINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        3 MG/KG          = 2
                                                        30 MG/KG         = 3
                                                        100MG/KG         = 4

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

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

      |
      |
  100 + 1                                              1      2         4  3
      |
      |                                                1      2    1    4  3  3     2
      |                                                            1       1  3   3 2  4       2
   95 +
      |                                                                    1      3 13 4      42   2
      |                                                                                            2    2
      |                                                                             13       14 3           4
   90 +                                                                                         3       2   4 42
      |
P     |                                                                                      1    1           42 42
E     |                                                                                           1    1         42   2
R  85 +                                                                                                        3  3
C     |                                                                                                11         4 4 2  2
E     |                                                                                                                  2  2
N     |                                                                                                 1 1       3 43
T  80 +                                                                                                   1 1        4  4
      |                                                                                                              3 3
S     |                                                                                                     1    1     3 3
U     |
R  75 +                                                                                                          1  1   44
V     |                                                                                                             1 1  44
I     |
V     |                                                                                                               11 33
A  70 +
L     |
      |
      |                                                                                                                   3 3
   65 +                                                                                                                   4 4
      |                                                                                                                1  1
      |
      |
   60 +
      |                                                                                                                   1 1
      |
      |
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.