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TDMS Study 05007-05 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 09/03/94   
EXP: 05007                      POLYSORBATE 80                 TIME: 11:42:45   
TEST: 05              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                          
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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Southern Research Inst                                    DATE: 09/03/94  
EXP: 05007                      POLYSORBATE 80                 TIME: 11:42:45  
TEST: 05              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 MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 59     UNCENSORED DEATHS 18     CENSORED DEATHS 8    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      90    168   260   272   436   440   472   492   538   575                 |
 |      580   634   637   639   640   654   707   715                             |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   704                             |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 19     CENSORED DEATHS 7    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      310   361   451   533   541   581   596   598   634   646                 |
 |      651   672   678   705   706   707   708   708   709                       |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457                                   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 5.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 18     CENSORED DEATHS 10   TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      147   150   170   280   561   570   604   608   613   614                 |
 |      637   644   645   672   708   709   715   717                             |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================

                                  POLYSORBATE 80


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |    98.3  96.6  94.9  93.2  93.2  87.9  84.0  80.1  70.3  66.3      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |2.5%       |   100.0 100.0 100.0  96.7  96.7  95.0  91.2  85.5  79.8  64.6      |
 |           |                                                                    |
 |           |                                                                    |
 |5.0%       |   100.0  95.0  95.0  93.3  93.3  93.3  93.3  87.2  75.1  64.9      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                UNTREATD         2.5%             5.0%          |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       66.3%            64.6%            64.9%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=1.000N         P=1.000N         P=1.000N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       497.2            605.0            542.4         |
 |NATURAL DEATHS (C)      |       (44.2)           (27.4)           (47.8)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       625.6            658.0            627.7         |
 |(STANDARD ERROR)        |       (20.6)           (14.7)           (20.2)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)

                                  POLYSORBATE 80


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 9    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      255   391   557   559   580   586   587   609   614   636                 |
 |      636   637   653   683   696   700   706   707   707   707                 |
 |      708                                                                       |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 10   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      114   192   247   437   458   498   499   523   585   588                 |
 |      588   610   628   637   638   639   651   672   703   706                 |
 |      707   707                                                                 |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 5.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 24     CENSORED DEATHS 10   TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      361   378   409   438   442   447   469   474   477   514                 |
 |      548   577   581   584   624   629   647   687   693   694                 |
 |      702   702   717   717                                                     |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 ==================================================================================

                                  POLYSORBATE 80


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0 100.0  98.3  98.3  96.7  96.7  96.7  86.8  75.0  59.2      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |2.5%       |   100.0  98.3  95.0  95.0  95.0  91.7  85.6  79.4  67.2  57.0      |
 |           |                                                                    |
 |           |                                                                    |
 |5.0%       |   100.0 100.0 100.0  98.3  95.0  83.9  81.8  73.6  67.5  53.2      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                UNTREATD         2.5%             5.0%          |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       59.2%            57.0%            53.2%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.388          P=0.740          P=0.431       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       615.0            546.7            563.0         |
 |NATURAL DEATHS (C)      |       (24.5)           (35.9)           (24.1)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       648.4            617.0            617.4         |
 |(STANDARD ERROR)        |       (15.0)           (19.2)           (16.6)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

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

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

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

      |
      |
  100 + 1             1        3                          2
      |               1        33 1                       2      2
      |
      |                         3 1 3             1              2              2
   95 +                             3             113                           2            2
      |                                            13                        1                   3
P     |                                                                                      22
E     |                                                                                       2  332
R  90 +                                                                      1     1
C     |                                                                                           32   23
E     |                                                                            1  1
N     |                                                                               1      1
T  85 +                                                                                                233  2
      |                                                                                      1     1        2 2
S     |
U     |                                                                                                  3  3
R  80 +                                                                                            1        1 2   2
V     |                                                                                                     33
I     |                                                                                                      33   22
V     |                                                                                                     11     2   2
A  75 +                                                                                                       3   3
L     |
      |                                                                                                      1 1  3     3
      |
   70 +                                                                                                        1       12
      |                                                                                                                131
      |
      |                                                                                                                  1  1
   65 +                                                                                                                 23  2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 5 obs hidden.

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

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

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

      |
      |
  100 + 1                  2                     1               3
      |                    2           2         1               3 3  1
      |
      |                                2        2                  3  1  3                      1
   95 +                                         2                        3   2
      |                                                                      23  2
      |                                                                                         1  1
      |                                                                          2     2           11
   90 +                                                                       3   3
      |
      |                                                                           33   2   2
      |                                                                            33               1   1
P  85 +                                                                                    2        2   11
E     |                                                                             3    3
R     |                                                                                                  1  1
C     |                                                                                  3     3
E  80 +                                                                                        3   32    2
N     |
T     |                                                                                                  2 21  1
      |                                                                                            33
S  75 +                                                                                                    22  1    1
U     |                                                                                             3      322
R     |                                                                                                             1 1
V     |
I  70 +                                                                                                    3  3
V     |                                                                                                      22       11
A     |                                                                                                       2   2  3
L     |
   65 +                                                                                                           2    2
      |                                                                                                              33
      |
      |                                                                                                               311
   60 +
      |                                                                                                                 1   1
      |                                                                                                                2 3  2
      |
   55 +
      |                                                                                                                  3  3
      |
      |
   50 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 7 obs hidden.