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TDMS Study 05144-01 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Mason                                                     DATE: 09/17/94   
EXP: 05144                      SAFFLOWER OIL                  TIME: 19:57:17   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 62204    
CONT: N01-ES-55123                                             CAS: 8001-23-8   
PATHOLOGIST: K. MURTHY                       S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Mason                                                     DATE: 09/17/94  
EXP: 05144                      SAFFLOWER OIL                  TIME: 19:57:17  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 62204   
CONT: N01-ES-55123                                             CAS: 8001-23-8  
PATHOLOGIST: K. MURTHY                       S. EUSTIS                         

                                   SAFFLOWER OIL


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 ML/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 20     CENSORED DEATHS 10   TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      457   476   601   610   613   627   635   641   647   661                 |
 |      671   672   684   691   692   692   692   708   710   715                 |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   462   462   462   462   462   462                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.5 MLKG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 17     CENSORED DEATHS 10   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      388   398   485   491   600   614   615   618   624   634                 |
 |      634   679   683   693   708   710   727                                   |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   462   462   462   462   462                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 5.0 MLKG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 10   TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      165   329   340   531   554   610   613   655   672   721                 |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   462   462   462   462   462                 |
 |                                                                                |
 ==================================================================================

                                   SAFFLOWER OIL


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 10.0    ML/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 15     CENSORED DEATHS 9    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      302   547   582   607   613   617   627   633   672   691                 |
 |      715   718   722   724   726                                               |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   461   462   462   462                       |
 |                                                                                |
 ==================================================================================

                                   SAFFLOWER OIL


                       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 ML/KG    |   100.0 100.0 100.0 100.0 100.0  96.3  96.3  94.3  80.3  60.2      |
 |           |                                                                    |
 |           |                                                                    |
 |2.5 MLKG   |   100.0 100.0 100.0 100.0  96.7  94.7  92.6  90.6  78.5  66.5      |
 |           |                                                                    |
 |           |                                                                    |
 |5.0 MLKG   |   100.0  98.3  98.3  95.0  95.0  95.0  93.0  91.0  84.9  80.9      |
 |           |                                                                    |
 |           |                                                                    |
 |10.0       |   100.0 100.0 100.0  98.3  98.3  98.3  98.3  94.4  84.6  70.8      |
 |ML/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 ML/KG      2.5 MLKG     5.0 MLKG     10.0     |
 |                                                                       ML/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       60.2%        66.5%        80.9%        70.8%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.182N     P=0.756N     P=0.075N     P=0.341N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       644.8        605.9        519.0        633.1    |
 |NATURAL DEATHS (C)      |       (15.7)       (25.4)       (57.2)       (28.0)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       656.4        649.6        649.4        664.9    |
 |(STANDARD ERROR)        |       (13.4)       (14.7)       (17.4)       (14.1)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                           SAFFLOWER OIL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 ML/KG          = 1
                                                        2.5 MLKG         = 2
                                                        5.0 MLKG         = 3
                                                        10.0    ML/KG    = 4

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

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

      |
      |
  100 + 1                         3                     4             2          1
      |                           3                     4   3         22         1 1           4
      |
      |                                                     3 3        2           1 2         4    4  1
   95 +                                                       3                      22     3       4   4
      |                                                                                                1 1
      |                                                                               2     3   3      244
      |                                                                                         3      2 2
P  90 +                                                                                                  141
E     |                                                                                                   411
R     |                                                                                                  3     3
C     |                                                                                                  22411
E  85 +                                                                                                   224  3  3
N     |                                                                                                      11
T     |                                                                                                    22 1  13  4   3
      |                                                                                                              4   3  3
S  80 +                                                                                                          11
U     |                                                                                                     2      2
R     |
V     |                                                                                                           121    44
I  75 +                                                                                                             22
V     |                                                                                                             11
A     |                                                                                                              2  2
L     |                                                                                                                   4 4
   70 +
      |                                                                                                                 2 2
      |
      |                                                                                                              1  1 2 2
   65 +
      |
      |                                                                                                                 11
      |
   60 +                                                                                                                  1  1
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 11 obs hidden.