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TDMS Study 05084-01 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Mason                                                     DATE: 09/10/94   
EXP: 05084                    TURMERIC OLEORESIN               TIME: 21:56:47   
TEST: 01              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: 09/10/94  
EXP: 05084                    TURMERIC OLEORESIN               TIME: 21:56:47  
TEST: 01              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 RATS
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 32     CENSORED DEATHS 10   TERMINAL 18        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      404   435   465   494   505   521   521   529   531   543                 |
 |      543   553   563   567   589   609   633   634   644   655                 |
 |      662   671   676   687   695   695   696   696   711   715                 |
 |      718   722                                                                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   459   459   459   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2,000PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 33     CENSORED DEATHS 10   TERMINAL 17        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      337   519   534   549   582   583   588   602   606   611                 |
 |      612   648   652   658   658   660   683   690   690   696                 |
 |      696   703   703   704   707   710   715   718   718   721                 |
 |      722   722   723                                                           |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   459   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 10,000  PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 35     CENSORED DEATHS 10   TERMINAL 15        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      141   199   337   464   467   499   532   539   556   568                 |
 |      579   585   594   612   634   645   648   653   654   661                 |
 |      662   667   674   676   682   682   687   695   697   703                 |
 |      707   715   715   722   722                                               |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   459   459   459   459   459                 |
 |                                                                                |
 ==================================================================================

                                TURMERIC OLEORESIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 50,000  PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 34     CENSORED DEATHS 9    TERMINAL 17        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      270   367   368   371   374   400   404   414   456   479                 |
 |      487   492   504   521   521   522   522   528   538   569                 |
 |      580   610   615   633   640   669   673   676   682   682                 |
 |      695   695   711   716                                                     |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   459   459                       |
 |                                                                                |
 ==================================================================================

                                TURMERIC OLEORESIN


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0 100.0  98.3  94.7  78.5  70.5  58.4  36.2      |
 |           |                                                                    |
 |           |                                                                    |
 |2,000PPM   |   100.0 100.0 100.0  98.3  98.3  98.3  94.3  84.3  68.2  34.1      |
 |           |                                                                    |
 |           |                                                                    |
 |10,000  PPM|   100.0  98.3  96.7  95.0  95.0  91.0  84.9  74.8  58.6  30.3      |
 |           |                                                                    |
 |           |                                                                    |
 |50,000  PPM|   100.0 100.0  98.3  98.3  86.7  83.0  64.8  60.7  52.6  34.4      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        2,000PPM     10,000  PPM  50,000  P|M
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       36.2%        34.1%        30.3%        34.4%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.258      P=0.707N     P=0.778      P=0.440  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       602.6        649.1        599.2        540.7    |
 |NATURAL DEATHS (C)      |       (16.1)       (14.3)       (23.4)       (21.0)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       616.4        639.8        608.1        581.5    |
 |(STANDARD ERROR)        |       (14.5)       (13.9)       (17.6)       (17.3)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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 RATS
                       FIRST TERMINAL SACRIFICE AT 727 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 17     CENSORED DEATHS 10   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      461   468   517   517   550   553   574   603   643   643                 |
 |      646   676   680   681   692   707   717                                   |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2,000PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 23     CENSORED DEATHS 10   TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      444   506   552   552   560   591   595   598   615   622                 |
 |      647   654   667   685   694   700   700   700   700   700                 |
 |      702   702   702                                                           |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 10,000  PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 10   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      414   455   456   462   489   519   526   528   556   576                 |
 |      577   591   643   647   655   677   680   688   700   700                 |
 |      708   708                                                                 |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   455   455   455   455   457                 |
 |                                                                                |
 ==================================================================================

                                TURMERIC OLEORESIN


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 727 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 50,000  PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 17     CENSORED DEATHS 9    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      311   359   367   493   510   518   528   598   624   632                 |
 |      659   661   673   673   700   708   721                                   |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   457   457   457   457   457   457                       |
 |                                                                                |
 ==================================================================================

                                TURMERIC OLEORESIN


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 727 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   727 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0 100.0 100.0  96.0  92.0  84.0  78.0  66.0      |
 |           |                                                                    |
 |           |                                                                    |
 |2,000PPM   |   100.0 100.0 100.0 100.0 100.0  98.3  96.3  84.3  76.3  54.2      |
 |           |                                                                    |
 |           |                                                                    |
 |10,000  PPM|   100.0 100.0 100.0 100.0  98.3  92.7  84.6  76.6  70.5  56.4      |
 |           |                                                                    |
 |           |                                                                    |
 |50,000  PPM|   100.0 100.0 100.0  96.7  95.0  95.0  87.1  85.1  77.2  67.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        2,000PPM     10,000  PPM  50,000  P|M
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       66.0%        54.2%        56.4%        67.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.549N     P=0.391      P=0.366      P=1.000  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       607.5        634.3        588.9        572.6    |
 |NATURAL DEATHS (C)      |       (20.4)       (15.4)       (20.6)       (31.5)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       648.0        646.3        631.1        642.7    |
 |(STANDARD ERROR)        |       (14.2)       (13.7)       (15.1)       (16.0)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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=RATS SEX=MALE -------------------------------------------------------

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

      |
      |
  100 + 1                      3                   4          2         1
      |                        3        3          4          2   4     1    1    1        2 2
      |                                                       3                   1   1      2 2
      |                                                           44    4             1 1      2    2
   90 +                                                                           3    31  13
      |                                                                 4 4      4         113      2  2
P     |                                                                          4  4        3  3      22
E     |                                                                             44      1 1 3 3     22
R  80 +                                                                              444          333
C     |                                                                                4   4  11 1  3 3  2    22
E     |                                                                                               3  3
N     |                                                                                          1    1  3  3
T  70 +                                                                                    44         1 1   3 32 2
      |                                                                                     44          1   1 33 2  2
S     |                                                                                      4    4         11      22
U     |                                                                                           44         1 1 3   22
R  60 +                                                                                            4     4     1 1
V     |                                                                                                  4  4    111  22
I     |                                                                                                     44     1 1
V     |                                                                                                      4    43311
A  50 +                                                                                                           44   22
L     |                                                                                                            4333 22
      |                                                                                                               1 1
      |                                                                                                             4 3311
   40 +                                                                                                                  22
      |                                                                                                               43411 1
      |                                                                                                                  32 2
      |
   30 +                                                                                                                   3 3
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 32 obs hidden.

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

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

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

      |
  100 + 1                                                 4               3   2  1
      |                                                   4      4        3   2 3       2
      |                                                                          11
      |                                                          44             331     21     2
   95 +                                                           4                   4
      |
      |                                                                          3   34 41     12
      |                                                                              3  44 3
   90 +                                                                                         2     2
      |                                                                                  4 33
      |                                                                                     4  1  1    4
      |                                                                                           1   221
P  85 +                                                                                     3   3      4   4
E     |                                                                                                212 441
R     |                                                                                         3  3     22
C     |                                                                                                     4    4
E  80 +                                                                                                   2  11
N     |                                                                                            3  3       22
T     |                                                                                                       1  4 1
      |                                                                                               3      3 2  211
S  75 +                                                                                                      33
U     |                                                                                                           242 4
R     |                                                                                                       33    112
V     |                                                                                                               4 4
I  70 +                                                                                                        3   3 1 1
V     |                                                                                                            33   44
A     |                                                                                                                1 14
L     |                                                                                                             33   11
   65 +                                                                                                              33
      |
      |
      |
   60 +                                                                                                               223
      |
      |
      |                                                                                                                 3 3
   55 +
      |                                                                                                                2  2
      |
      |
   50 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 10 obs hidden.