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TDMS Study 05084-02 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Mason                                                     DATE: 09/11/94   
EXP: 05084                    TURMERIC OLEORESIN               TIME: 00:39:14   
TEST: 02              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60015    
CONT: N01ES9561902                                             CAS: 458-37-7    
PATHOLOGIST: R. FLEISCHMAN                                                      
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REASONS FOR REMOVAL:                                                            
                                                                                
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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Mason                                                     DATE: 09/11/94  
EXP: 05084                    TURMERIC OLEORESIN               TIME: 00:39:14  
TEST: 02              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60015   
CONT: N01ES9561902                                             CAS: 458-37-7   
PATHOLOGIST: R. FLEISCHMAN                                                     

                                TURMERIC OLEORESIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 7      CENSORED DEATHS 10   TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      159   479   609   618   634   664   717                                   |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2,000PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 7      CENSORED DEATHS 10   TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      507   542   661   679   691   693   715                                   |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   455   455   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 10,000  PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 10   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      224   399   541   541   595   639   640   647   708   713                 |
 |      713   716   725                                                           |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================

                                TURMERIC OLEORESIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 50,000  PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 8      CENSORED DEATHS 10   TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      437   537   598   627   678   680   724   724                             |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================

                                TURMERIC OLEORESIN


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0  98.3  98.3  98.3  98.3  96.3  96.3  96.3  88.3  86.3      |
 |           |                                                                    |
 |           |                                                                    |
 |2,000PPM   |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  96.0  94.0  86.0      |
 |           |                                                                    |
 |           |                                                                    |
 |10,000  PPM|   100.0 100.0  98.3  98.3  96.7  96.7  92.6  90.6  84.6  74.5      |
 |           |                                                                    |
 |           |                                                                    |
 |50,000  PPM|   100.0 100.0 100.0 100.0 100.0  98.3  96.3  94.3  92.3  84.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        2,000PPM     10,000  PPM  50,000  P|M
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       86.3%        86.0%        74.5%        84.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=1.000N     P=1.000N     P=0.223      P=1.000  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       554.3        641.1        600.1        625.6    |
 |NATURAL DEATHS (C)      |       (71.4)       (31.0)       (40.9)       (35.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       663.1        673.2        655.6        669.8    |
 |(STANDARD ERROR)        |       (16.1)       (13.6)       (15.9)       (13.9)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                TURMERIC OLEORESIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 11   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      515   522   536   586   628   673   681   701   703   703                 |
 |  CENSORED DEATHS                                                               |
 |      84    450   450   450   450   450   450   450   453   453                 |
 |      453                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2,000PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 9      CENSORED DEATHS 10   TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      206   281   467   552   599   666   681   701   718                       |
 |  CENSORED DEATHS                                                               |
 |      450   450   450   450   453   453   453   453   453   453                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 10,000  PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 17     CENSORED DEATHS 9    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      6     9     13    400   437   524   534   609   662   667                 |
 |      667   677   703   704   705   714   721                                   |
 |  CENSORED DEATHS                                                               |
 |      450   450   450   450   450   450   453   453   453                       |
 |                                                                                |
 ==================================================================================

                                TURMERIC OLEORESIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 50,000  PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 8      CENSORED DEATHS 10   TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      233   449   621   662   667   701   703   703                             |
 |  CENSORED DEATHS                                                               |
 |      450   450   450   453   453   453   453   453   453   453                 |
 |                                                                                |
 ==================================================================================

                                TURMERIC OLEORESIN


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0 100.0 100.0 100.0  93.9  91.8  89.8  79.6      |
 |           |                                                                    |
 |           |                                                                    |
 |2,000PPM   |   100.0 100.0  98.3  96.7  96.7  94.7  94.7  90.6  90.6  82.6      |
 |           |                                                                    |
 |           |                                                                    |
 |10,000  PPM|    95.0  95.0  95.0  95.0  93.3  91.7  87.7  87.7  83.7  67.8      |
 |           |                                                                    |
 |           |                                                                    |
 |50,000  PPM|   100.0 100.0  98.3  98.3  98.3  96.7  96.7  96.7  92.6  84.6      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        2,000PPM     10,000  PPM  50,000  P|M
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       79.6%        82.6%        67.8%        84.6%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.505N     P=0.980N     P=0.198      P=0.743N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       624.8        541.2        514.8        592.4    |
 |NATURAL DEATHS (C)      |       (24.8)       (62.5)       (63.0)       (59.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       654.5        654.6        626.6        664.6    |
 |(STANDARD ERROR)        |       (17.0)       (17.1)       (23.3)       (15.6)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                         TURMERIC OLEORESIN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        2,000PPM         = 2
                                                        10,000  PPM      = 3
                                                        50,000  PPM      = 4

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

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

      |
      |
  100 + 1                        1         3                                 4          2
      |                          1         3                           3     4      1        4
      |                                                                                 2     2
      |                                                                3            1        42        41        2
P  95 +
E     |                                                                                                41 14     2 2
R     |                                                                                       3       3   141      2 2
C     |                                                                                               3      3
E  90 +                                                                                                     1    1 44
N     |                                                                                                          1  4    14
T     |                                                                                                              2   2
      |                                                                                                      33          1  1
S  85 +                                                                                                       3         3
U     |                                                                                                                   4 4
R     |
V     |
I  80 +
V     |                                                                                                                 33
A     |
L     |                                                                                                                  33
   75 +                                                                                                                   3 3
      |
      |
      |
   70 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 7 obs hidden.

                                                         TURMERIC OLEORESIN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        2,000PPM         = 2
                                                        10,000  PPM      = 3
                                                        50,000  PPM      = 4

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

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

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

                                                                   WEEK

NOTE: 7 obs hidden.