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TDMS Study 88066-01 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: A. D. Little                                           POLYVINYL ALCOHOL                                  DATE: 08/15/96       
EXPERIMENT: 88066 TEST: 01                                                                                     TIME: 14:06:51       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-15330                              ROUTE: VAGINAL                                                 NTP C#: 88066        
PATHOLOGIST: GOAD, MARY                                                                                        CAS: 9002-89-5       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                       VEHICLE CONTROL VS 25%                                                       
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 002    VEHICLE CONTROL                                                               
                                       INCLUDE 003    25%                                                                           
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: A. D. Little                                           POLYVINYL ALCOHOL                                  DATE: 08/15/96      
EXPERIMENT: 88066 TEST: 01                                                                                     TIME: 14:06:51      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-15330                              ROUTE: VAGINAL                                                 NTP C#: 88066       
PATHOLOGIST: GOAD, MARY                                                                                        CAS: 9002-89-5      
                                 POLYVINYL ALCOHOL

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 100    UNCENSORED DEATHS 45     CENSORED DEATHS 4    TERMINAL 51        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      205   532   542   548   548   548   588   588   609   611                 |
 |      611   611   613   620   627   634   637   639   640   643                 |
 |      646   654   654   658   661   668   671   675   675   675                 |
 |      675   679   679   690   690   690   694   705   711   711                 |
 |      717   721   722   722   728                                               |
 |  CENSORED DEATHS                                                               |
 |      313   314   314   462                                                     |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 25%                                      |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 100    UNCENSORED DEATHS 34     CENSORED DEATHS 5    TERMINAL 61        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      72    324   372   514   542   553   619   620   620   624                 |
 |      624   627   634   638   640   646   646   651   658   661                 |
 |      668   675   682   686   688   690   696   697   701   704                 |
 |      708   714   721   721                                                     |
 |  CENSORED DEATHS                                                               |
 |      112   313   504   507   637                                               |
 |                                                                                |
 ==================================================================================
                                 POLYVINYL ALCOHOL

                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0  99.0  99.0  99.0  99.0  96.9  91.7  74.0  53.1      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |25%        |    99.0  99.0  99.0  98.0  97.0  97.0  94.9  93.8  79.1  64.4      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                        DOSE                    |
 |                                                                                |
 |                                VEHICLE                   25%                   |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       53.1%                     64.4%                 |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.158N                  P=0.158N              |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       639.2                     618.7                 |
 |NATURAL DEATHS (C)      |       (12.6)                    (22.4)                |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       673.5                     675.8                 |
 |(STANDARD ERROR)        |       ( 9.8)                    (11.7)                |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                         POLYVINYL ALCOHOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        25%              = 2

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

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

      |
      |
  100 + 1           2                    1
      |             2                    1                  2                               1
      |                                                     2      2                     2  1 11
      |                                                                                  2    2
   95 +                                                                                       22
      |                                                                                        1    1     2
      |
      |                                                                                             1   1122
   90 +
      |
      |                                                                                                    22
      |                                                                                                  11 22
P  85 +                                                                                                   11122
E     |
R     |                                                                                                     11
C     |                                                                                                       22
E  80 +                                                                                                        2 2
N     |                                                                                                      111 22
T     |                                                                                                           222
      |
S  75 +                                                                                                        1 1  22
U     |                                                                                                          11
R     |                                                                                                           11 22
V     |                                                                                                               22
I  70 +
V     |                                                                                                                22
A     |
L     |                                                                                                            1 1  22
   65 +
      |                                                                                                                  2  2
      |                                                                                                              11
      |                                                                                                               11
   60 +                                                                                                                11
      |                                                                                                                 11
      |
      |                                                                                                                  11
   55 +
      |                                                                                                                   1 1
      |
      |
   50 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.