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TDMS Study 05057-01 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Mason                                                     DATE: 09/08/94   
EXP: 05057                       HC YELLOW 4                   TIME: 04:42:19   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 56019    
CONT: N01ES9561901                                             CAS: 5982043-8   
PATHOLOGIST: K. MURTHY                       S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


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TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Mason                                                     DATE: 09/08/94  
EXP: 05057                       HC YELLOW 4                   TIME: 04:42:19  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 56019   
CONT: N01ES9561901                                             CAS: 5982043-8  
PATHOLOGIST: K. MURTHY                       S. EUSTIS                         

                                    HC YELLOW 4


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATED 61 UM                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 30     CENSORED DEATHS 19   TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      288   470   485   508   587   598   605   610   619   625                 |
 |      637   637   639   651   655   658   662   665   666   673                 |
 |      689   694   707   710   710   713   721   722   724   725                 |
 |  CENSORED DEATHS                                                               |
 |      175   175   175   175   175   175   176   176   176   176                 |
 |      470   470   470   470   470   470   470   470   470                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.25%    61                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 21     CENSORED DEATHS 20   TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      367   396   467   481   588   619   620   623   626   626                 |
 |      646   653   658   668   672   673   718   723   723   728                 |
 |      728                                                                       |
 |  CENSORED DEATHS                                                               |
 |      175   175   175   176   176   176   176   176   176   176                 |
 |      470   470   470   470   470   470   470   470   470   470                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5%    61                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 69     UNCENSORED DEATHS 21     CENSORED DEATHS 20   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      367   430   436   553   557   570   588   605   654   658                 |
 |      668   676   680   694   694   694   696   702   704   714                 |
 |      715                                                                       |
 |  CENSORED DEATHS                                                               |
 |      175   175   175   175   175   175   176   176   176   176                 |
 |      470   470   470   470   470   470   470   470   470   470                 |
 |                                                                                |
 ==================================================================================

                                    HC YELLOW 4


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATED  |   100.0 100.0 100.0  98.3  98.3  94.7  92.7  86.8  65.1  41.4      |
 |61 UM      |                                                                    |
 |           |                                                                    |
 |0.25%    61|   100.0 100.0 100.0 100.0  96.7  93.0  93.0  91.0  74.8  58.6      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5%    61 |   100.0 100.0 100.0 100.0  98.3  94.9  94.9  84.6  80.5  57.8      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                UNTREATED        0.25%    61      0.5%    61    |
 |                                61 UM                                           |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       41.4%            58.6%            57.8%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.141N         P=0.139N         P=0.174N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       635.1            619.2            621.7         |
 |NATURAL DEATHS (C)      |       (17.2)           (23.1)           (22.4)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       576.4            580.0            578.6         |
 |(STANDARD ERROR)        |       (23.0)           (23.4)           (23.7)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                    HC YELLOW 4


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATED 61UF                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 23     CENSORED DEATHS 20   TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      409   422   447   531   582   600   612   625   645   647                 |
 |      650   658   658   658   692   699   700   701   702   710                 |
 |      710   723   728                                                           |
 |  CENSORED DEATHS                                                               |
 |      182   182   182   183   183   183   183   183   183   183                 |
 |      464   464   464   464   464   464   464   464   464   464                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5%    61                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 19     CENSORED DEATHS 20   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      478   544   545   611   612   619   628   664   666   668                 |
 |      672   685   686   710   710   710   710   713   713                       |
 |  CENSORED DEATHS                                                               |
 |      182   182   182   182   183   183   183   183   183   183                 |
 |      464   464   464   464   464   464   464   464   464   464                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.0%    61                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 16     CENSORED DEATHS 20   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      497   531   545   557   632   632   643   650   651   672                 |
 |      686   692   710   715   716   722                                         |
 |  CENSORED DEATHS                                                               |
 |      182   182   182   182   182   182   182   182   183   183                 |
 |      464   464   464   464   464   464   464   464   464   464                 |
 |                                                                                |
 ==================================================================================

                                    HC YELLOW 4


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATED  |   100.0 100.0 100.0 100.0  96.7  95.0  93.0  88.9  72.8  54.6      |
 |61UF       |                                                                    |
 |           |                                                                    |
 |0.5%    61 |   100.0 100.0 100.0 100.0 100.0  98.0  94.0  94.0  84.0  62.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1.0%    61 |   100.0 100.0 100.0 100.0 100.0 100.0  94.0  92.0  82.0  68.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                UNTREATED        0.5%    61       1.0%    61    |
 |                                61UF                                            |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       54.6%            62.0%            68.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.168N         P=0.453N         P=0.210N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       630.8            649.7            640.7         |
 |NATURAL DEATHS (C)      |       (19.7)           (15.5)           (18.0)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       580.8            591.6            592.8         |
 |(STANDARD ERROR)        |       (23.1)           (23.1)           (23.2)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                            HC YELLOW 4
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATED 61 UM  = 1
                                                        0.25%    61      = 2
                                                        0.5%    61       = 3

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

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

      |
      |
  100 + 1                                             1           2
      |                                               1           2    2    33    21 1
      |                                                                      3    2 21  1      3
      |                                                                             2   1      33   1
P  90 +                                                                                         3 3 1  11 2
E     |                                                                                           3 3   11
R     |                                                                                                 3112   3
C     |                                                                                                   11
E  80 +                                                                                                    11 22  3
N     |                                                                                                     11    333
T     |                                                                                                      112  2 3 3
      |                                                                                                       11
S  70 +                                                                                                        1 122
U     |                                                                                                            2     22
R     |                                                                                                          11   33
V     |                                                                                                           11   33
I  60 +                                                                                                            1 11 33
V     |                                                                                                               11 32 2
A     |                                                                                                                11
L     |
   50 +                                                                                                                 11
      |                                                                                                                  11
      |
      |                                                                                                                   1 1
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 20 obs hidden.

                                                            HC YELLOW 4
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATED 61UF   = 1
                                                        0.5%    61       = 2
                                                        1.0%    61       = 3

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

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

      |
      |
  100 + 1                                                                1          2 3
      |                                                                  1 1
      |                                                                             2 3     3 2
      |                                                                    1  1             3 3
   95 +                                                                       1             1
      |                                                                                       2 3        2
      |                                                                                     1   3   1       3
      |                                                                                             1  1
   90 +                                                                                                  22
      |                                                                                                1 1
P     |                                                                                                  12133
E     |                                                                                                    2 33  2
R  85 +                                                                                                    1  1
C     |                                                                                                          22
E     |                                                                                                       3   3
N     |
T  80 +                                                                                                           3 3
      |                                                                                                       11
S     |                                                                                                           2 23
U     |                                                                                                              3  3
R  75 +
V     |                                                                                                             2   23
I     |                                                                                                        1     1
V     |                                                                                                              11
A  70 +                                                                                                                  33
L     |
      |                                                                                                                   3 3
      |                                                                                                               11
   65 +
      |
      |                                                                                                                11   2
      |
   60 +
      |                                                                                                                 1 1
      |
      |
   55 +                                                                                                                   1 1
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 7 obs hidden.