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TDMS Study 05704-01 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: IRDC                                                      DATE: 09/18/94   
EXP: 05704                       RESORCINOL                    TIME: 17:09:51   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 05970A   
CONT: 05700-04                                                 CAS: 108-46-3    
PATHOLOGIST: F. VOELKER                      S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: IRDC                                                      DATE: 09/18/94  
EXP: 05704                       RESORCINOL                    TIME: 17:09:51  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 05970A  
CONT: 05700-04                                                 CAS: 108-46-3   
PATHOLOGIST: F. VOELKER                      S. EUSTIS                         

                                    RESORCINOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL M                                |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 12     CENSORED DEATHS 11   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      331   517   567   612   628   635   692   700   711   717                 |
 |      721   724                                                                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |      695                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 112MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 7      CENSORED DEATHS 10   TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      626   651   664   686   698   715   716                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 225MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 15     CENSORED DEATHS 11   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      6     15    133   140   141   209   241   310   429   590                 |
 |      628   641   653   679   708                                               |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |      574                                                                       |
 |                                                                                |
 ==================================================================================

                                    RESORCINOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL M  |   100.0 100.0 100.0  98.3  98.3  98.3  96.3  94.3  88.3  76.0      |
 |           |                                                                    |
 |           |                                                                    |
 |112MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  94.0  86.0      |
 |           |                                                                    |
 |           |                                                                    |
 |225MG/KG   |    96.7  91.7  88.3  86.7  86.7  85.0  85.0  82.9  76.5  72.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                CONTROL M        112MG/KG         225MG/KG      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       76.0%            86.0%            72.3%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.381          P=0.280N         P=0.462       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       629.6            679.4            368.2         |
 |NATURAL DEATHS (C)      |       (33.3)           (12.8)           (67.2)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       663.7            678.4            591.3         |
 |(STANDARD ERROR)        |       (14.6)           (13.2)           (26.7)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                    RESORCINOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL F                                |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 11     CENSORED DEATHS 11   TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      127   500   617   620   622   625   639   672   697   715                 |
 |      727                                                                       |
 |  CENSORED DEATHS                                                               |
 |      393   456   456   456   456   456   456   456   456   456                 |
 |      456                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 112MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 17     CENSORED DEATHS 10   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      5     7     124   260   484   582   600   601   604   604                 |
 |      626   639   666   682   699   699   715                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 225MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 16     CENSORED DEATHS 10   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      43    140   155   313   400   497   621   632   636   676                 |
 |      680   681   682   685   688   708                                         |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                                    RESORCINOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL F  |   100.0  98.3  98.3  98.3  98.3  98.3  96.3  96.3  86.0  77.8      |
 |           |                                                                    |
 |           |                                                                    |
 |112MG/KG   |    96.7  95.0  93.3  93.3  93.3  91.3  91.3  81.2  77.1  67.0      |
 |           |                                                                    |
 |           |                                                                    |
 |225MG/KG   |    98.3  95.0  95.0  93.3  91.7  91.7  89.6  89.6  83.5  69.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                CONTROL F        112MG/KG         225MG/KG      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       77.8%            67.0%            69.3%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.327          P=0.232          P=0.359       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       596.5            505.7            514.8         |
 |NATURAL DEATHS (C)      |       (50.5)           (59.3)           (57.4)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       654.2            620.8            627.0         |
 |(STANDARD ERROR)        |       (16.8)           (22.8)           (21.6)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                             RESORCINOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL M        = 1
                                                        112MG/KG         = 2
                                                        225MG/KG         = 3

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

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

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

                                                                   WEEK

NOTE: 2 obs hidden.

                                                             RESORCINOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL F        = 1
                                                        112MG/KG         = 2
                                                        225MG/KG         = 3

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

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

      |
      |
  100 + 12      3            1
      |         3            13                                                        1
      |
      |  2                  2 3  3                                                     1                  1
   95 +                     2    3                2       3
      |                                           2       3             3            2
P     |
E     |                                                                 3            23             2
R  90 +                                                                               3                   11
C     |                                                                                             2  2
E     |                                                                                                   3131
N     |                                                                                                      1    1
T  85 +                                                                                                22
      |                                                                                                     3     13  1
S     |                                                                                                               1  1
U     |                                                                                                 2  2       33
R  80 +                                                                                                                  11
V     |                                                                                                    2 2
I     |                                                                                                      2    2       1 1
V     |
A  75 +                                                                                                           2 2
L     |                                                                                                             33
      |                                                                                                             2 2
      |                                                                                                              3  3
   70 +
      |                                                                                                               2 32  3
      |                                                                                                                  2  2
      |
   65 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 3 obs hidden.