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TDMS Study 05102-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                    BENZETHONIUM CHLORIDE                                DATE: 05/19/95       
EXPERIMENT: 05102 TEST: 06                                                                                     TIME: 18:49:18       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75177                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 61494B       
PATHOLOGIST: A. SINGER                       S. EUSTIS                                                         CAS: 121-54-0        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Columbus                                    BENZETHONIUM CHLORIDE                                DATE: 05/19/95      
EXPERIMENT: 05102 TEST: 06                                                                                     TIME: 18:49:18      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-75177                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 61494B      
PATHOLOGIST: A. SINGER                       S. EUSTIS                                                         CAS: 121-54-0       

                               BENZETHONIUM CHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0MG/KG                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 7      CENSORED DEATHS 10   TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      577   603   613   637   655   717   719                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = .15MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 59     UNCENSORED DEATHS 12     CENSORED DEATHS 9    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      513   571   621   624   695   701   703   712   712   717                 |
 |      719   721                                                                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 59     UNCENSORED DEATHS 8      CENSORED DEATHS 9    TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      560   635   638   660   663   684   713   727                             |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456                       |
 |                                                                                |
 ==================================================================================

                               BENZETHONIUM CHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1.5MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 11     CENSORED DEATHS 10   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      518   584   612   659   684   687   695   705   712   719                 |
 |      725                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                               BENZETHONIUM CHLORIDE


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0MG/KG     |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  90.0  86.0      |
 |           |                                                                    |
 |           |                                                                    |
 |.15MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  96.0  92.0  76.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0  90.0  84.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1.5MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  96.0  92.0  78.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       86.0%        76.0%        84.0%        78.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.671      P=0.320      P=1.000      P=0.449  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       645.9        667.4        660.0        663.6    |
 |NATURAL DEATHS (C)      |       (20.8)       (19.9)       (18.4)       (19.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       673.8        674.8        678.0        671.5    |
 |(STANDARD ERROR)        |       (13.3)       (13.2)       (13.0)       (13.4)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                               BENZETHONIUM CHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0MG/KG                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 9    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      317   428   568   632   660   674   677   687   689   691                 |
 |      698   719   722                                                           |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   639                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = .15MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 19     CENSORED DEATHS 7    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      268   308   372   459   471   512   518   543   565   583                 |
 |      596   597   613   626   635   656   699   701   715                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456                                   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 58     UNCENSORED DEATHS 17     CENSORED DEATHS 10   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      526   568   591   591   609   621   648   664   674   677                 |
 |      690   697   698   704   712   717   718                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                               BENZETHONIUM CHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1.5MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 20     CENSORED DEATHS 6    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      120   249   316   428   479   485   520   551   589   612                 |
 |      647   682   689   690   691   695   698   698   698   720                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456                                         |
 |                                                                                |
 ==================================================================================

                               BENZETHONIUM CHLORIDE


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0MG/KG     |   100.0 100.0 100.0  98.3  98.3  96.7  96.7  94.7  90.8  75.0      |
 |           |                                                                    |
 |           |                                                                    |
 |.15MG/KG   |   100.0 100.0  98.3  96.7  95.0  91.2  85.5  77.9  70.3  64.6      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  97.9  91.7  83.3  64.6      |
 |           |                                                                    |
 |           |                                                                    |
 |1.5MG/KG   |   100.0  98.3  96.7  95.0  95.0  89.6  87.7  84.0  80.3  63.5      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       75.0%        64.6%        64.6%        63.5%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.406      P=0.222      P=0.373      P=0.226  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       627.8        549.3        653.2        562.9    |
 |NATURAL DEATHS (C)      |       (33.9)       (29.3)       (14.2)       (38.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       669.2        640.3        659.7        646.3    |
 |(STANDARD ERROR)        |       (14.1)       (16.4)       (13.7)       (18.0)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                       BENZETHONIUM CHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0MG/KG           = 1
                                                        .15MG/KG         = 2
                                                        0.5MG/KG         = 3
                                                        1.5MG/KG         = 4

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

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

      |
      |
  100 + 1                                                                                2      3  1
      |
      |                                                                                  2      3 214   1   3
      |
P  96 +                                                                                           2 4   112 33
E     |
R     |                                                                                                  12213   3
C     |
E  92 +                                                                                                    21  1 4  4 2
N     |
T     |                                                                                                        1 3  3422 1
      |
S  88 +                                                                                                             344 3
U     |
R     |                                                                                                               42213 1
V     |
I  84 +                                                                                                                44 3 3
V     |
A     |                                                                                                                 22
L     |
   80 +                                                                                                                  44
      |
      |                                                                                                                   4 4
      |
   76 +                                                                                                                  2  2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 13 obs hidden.

                                                       BENZETHONIUM CHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0MG/KG           = 1
                                                        .15MG/KG         = 2
                                                        0.5MG/KG         = 3
                                                        1.5MG/KG         = 4

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

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

      |
      |
  100 + 1                   4                      2       1                                3
      |                     4                   4  2    2  1                1
      |                                                                                     3     3
      |                                         4       2  4       2        1                     1   3
   95 +                                                    4       2        4    2                1         1
      |                                                                     4       4
      |                                                                          2 2                        1    1
      |                                                                            244   2            3 3        1 1
P  90 +                                                                              4     4            3 3
E     |
R     |                                                                                  2 4  24          3   3    1 1
C     |                                                                                        4      4
E  85 +                                                                                       2  2            3  3
N     |                                                                                          2  2 4  4       3 3
T     |                                                                                                  4    4
      |                                                                                             2  2             11
S  80 +                                                                                                       4     4
U     |                                                                                                            3431  1
R     |                                                                                                2 2           33  11
V     |                                                                                                  2 2
I  75 +                                                                                                                   1 1
V     |                                                                                                    22
A     |                                                                                                     2  2     433
L     |                                                                                                                33
   70 +                                                                                                        2      2
      |                                                                                                               2233
      |
      |                                                                                                                2 2
   65 +                                                                                                               4  2  2
      |                                                                                                                  4  4
      |
      |
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 9 obs hidden.