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TDMS Study 05007-06 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 09/03/94   
EXP: 05007                      POLYSORBATE 80                 TIME: 13:00:26   
TEST: 06              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60286    
CONT: N01CP9565102                                             CAS: 9005-65-6   
PATHOLOGIST: J. SAGARTZ                      S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
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REMOVAL DATE RANGE:                                                             


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INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Southern Research Inst                                    DATE: 09/03/94  
EXP: 05007                      POLYSORBATE 80                 TIME: 13:00:26  
TEST: 06              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60286   
CONT: N01CP9565102                                             CAS: 9005-65-6  
PATHOLOGIST: J. SAGARTZ                      S. EUSTIS                         

                                  POLYSORBATE 80


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 10   TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      455   464   470   493   561   561   567   585   614   630                 |
 |      640   640   662   681   688   698   700   701   712   717                 |
 |      723                                                                       |
 |  CENSORED DEATHS                                                               |
 |      462   462   462   462   462   462   462   462   462   462                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 32     CENSORED DEATHS 10   TERMINAL 18        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      98    477   503   535   589   606   613   616   617   618                 |
 |      632   635   637   638   640   644   646   658   667   675                 |
 |      677   683   687   692   695   700   701   701   708   710                 |
 |      722   724                                                                 |
 |  CENSORED DEATHS                                                               |
 |      462   462   462   462   462   462   462   462   462   462                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 5.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 32     CENSORED DEATHS 10   TERMINAL 18        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      258   400   454   458   461   494   503   570   574   575                 |
 |      597   625   637   644   646   646   647   668   679   682                 |
 |      682   688   689   699   699   699   699   700   701   709                 |
 |      710   724                                                                 |
 |  CENSORED DEATHS                                                               |
 |      462   462   462   462   462   462   462   462   462   462                 |
 |                                                                                |
 ==================================================================================

                                  POLYSORBATE 80


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0 100.0 100.0 100.0 100.0  94.3  92.3  84.3  74.3  58.2      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |2.5%       |   100.0  98.3  98.3  98.3  98.3  96.3  92.3  90.3  64.2  36.1      |
 |           |                                                                    |
 |           |                                                                    |
 |5.0%       |   100.0 100.0  98.3  98.3  96.7  91.7  87.6  79.4  67.2  36.7      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                UNTREATD         2.5%             5.0%          |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       58.2%            36.1%            36.7%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.043          P=0.058          P=0.048       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       617.2            629.5            613.0         |
 |NATURAL DEATHS (C)      |       (19.5)           (20.1)           (19.7)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       645.4            631.4            622.7         |
 |(STANDARD ERROR)        |       (14.2)           (15.6)           (15.5)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                  POLYSORBATE 80


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 27     CENSORED DEATHS 10   TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      195   367   514   548   561   573   575   594   617   617                 |
 |      629   630   631   640   644   645   645   646   662   675                 |
 |      699   701   709   710   710   710   716                                   |
 |  CENSORED DEATHS                                                               |
 |      463   463   463   463   463   463   463   463   463   463                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 25     CENSORED DEATHS 10   TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      273   323   466   467   467   532   561   610   619   623                 |
 |      630   637   638   640   640   646   687   700   700   702                 |
 |      702   716   717   717   724                                               |
 |  CENSORED DEATHS                                                               |
 |      463   463   463   463   463   463   463   463   463   463                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 5.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 25     CENSORED DEATHS 10   TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      316   432   535   567   568   571   610   610   612   612                 |
 |      619   623   633   634   640   644   694   694   698   699                 |
 |      700   702   708   716   717                                               |
 |  CENSORED DEATHS                                                               |
 |      463   463   463   463   463   463   463   463   463   463                 |
 |                                                                                |
 ==================================================================================

                                  POLYSORBATE 80


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0 100.0  98.3  98.3  96.7  96.7  94.7  84.6  62.4  46.3      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |2.5%       |   100.0 100.0 100.0  96.7  96.7  90.6  88.6  86.6  68.5  50.3      |
 |           |                                                                    |
 |           |                                                                    |
 |5.0%       |   100.0 100.0 100.0  98.3  98.3  96.7  94.7  88.6  68.5  50.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                UNTREATD         2.5%             5.0%          |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       46.3%            50.3%            50.3%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.779N         P=0.780N         P=0.843N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       613.4            605.5            622.2         |
 |NATURAL DEATHS (C)      |       (21.7)           (24.4)           (18.6)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       632.7            633.2            640.2         |
 |(STANDARD ERROR)        |       (15.4)           (15.9)           (14.3)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                           POLYSORBATE 80
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        2.5%             = 2
                                                        5.0%             = 3

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

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

      |
      |
  100 + 1              2                         3                              1
      |                2                         3                      3       1 112  2
      |                                                                         33 1  12     2
      |                                                                          3    1      2   1    2
   90 +                                                                               33              2 2
      |                                                                                3         13 1   22
P     |                                                                                             1    12
E     |                                                                                           33   3 1 1
R  80 +                                                                                                3  2121
C     |                                                                                                    331   1
E     |                                                                                                     22   1  1
N     |                                                                                                      33     11
T  70 +                                                                                                              11
      |                                                                                                      22   3
S     |                                                                                                       22  23  111
U     |                                                                                                           223   11
R  60 +                                                                                                             33   11
V     |                                                                                                            22     1 1
I     |                                                                                                             223
V     |                                                                                                              22
A  50 +
L     |                                                                                                               22
      |                                                                                                               322
      |                                                                                                                33
   40 +                                                                                                                 2 2
      |                                                                                                                 3 3 3
      |                                                                                                                   2 2
      |
   30 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 20 obs hidden.

                                                           POLYSORBATE 80
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        2.5%             = 2
                                                        5.0%             = 3

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

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

         |
         |
  104.72 +
         |
         |1                              1           2       3
         |                               1           2       32     1         3
   96.67 +                                                    2     1         3     2      1   3
         |                                                                                 1   3 1 3
         |                                                                                       1 13
         |                                                                          2         2    11
P  88.61 +                                                                                    2    211     3
E        |                                                                                         2 1  1  2
R        |                                                                                              1  21
C        |
E  80.56 +                                                                                                 311
N        |                                                                                                   22
T        |                                                                                                  3112
         |                                                                                                    11
S  72.50 +                                                                                                    33
U        |                                                                                                     11
R        |                                                                                                     32      23
V        |                                                                                                             22
I  64.44 +                                                                                                      1  1
V        |                                                                                                         1 1  22
A        |                                                                                                           1  1
L        |                                                                                                              11 2
   56.39 +                                                                                                               11
         |                                                                                                                33
         |                                                                                                                 22
         |                                                                                                                 32 2
   48.33 +                                                                                                                11
         |                                                                                                                 1  1
         |
         |
   40.28 +
         |
         -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
          0         10         20         30         40         50         60         70         80         90         100       110

                                                                     WEEK

NOTE: 18 obs hidden.