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TDMS Study 05121-07 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                             SCOPOLAMINE HYDROBROMIDE TRIHYDRATE                         DATE: 04/03/96       
EXPERIMENT: 05121 TEST: 07                                                                                     TIME: 22:23:48       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85227                              ROUTE: GAVAGE                                                  NTP C#: 03098C       
PATHOLOGIST: A. SINGER                                                                                         CAS: 6533-68-2       
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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                             SCOPOLAMINE HYDROBROMIDE TRIHYDRATE                         DATE: 04/03/96      
EXPERIMENT: 05121 TEST: 07                                                                                     TIME: 22:23:48      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-85227                              ROUTE: GAVAGE                                                  NTP C#: 03098C      
PATHOLOGIST: A. SINGER                                                                                         CAS: 6533-68-2      
                        SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 726 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 10     CENSORED DEATHS 20   TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      294   447   540   647   680   683   694   700   707   725                 |
 |  CENSORED DEATHS                                                               |
 |      449   456   456   456   456   456   456   456   456   456                 |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0 MG/KG FEED RTD                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 8      CENSORED DEATHS 11   TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      15    15    15    24    24    532   606   721                             |
 |  CENSORED DEATHS                                                               |
 |      7     456   456   456   456   456   456   456   456   456                 |
 |      456                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 11     CENSORED DEATHS 20   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      405   541   604   618   663   669   692   705   707   707                 |
 |      709                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================
                        SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 726 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 5 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 9      CENSORED DEATHS 22   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      376   520   560   590   594   606   691   693   707                       |
 |  CENSORED DEATHS                                                               |
 |      50    131   456   456   456   456   456   456   456   456                 |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |      456   456                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 25 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 9      CENSORED DEATHS 22   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      405   405   432   587   594   622   697   705   707                       |
 |  CENSORED DEATHS                                                               |
 |      300   456   456   456   456   456   456   456   456   456                 |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |      456   627                                                                 |
 |                                                                                |
 ==================================================================================
                        SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 726 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   726 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0  98.6  98.6  97.1  95.1  95.1  93.1  81.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0          |    91.5  91.5  91.5  91.5  91.5  91.5  89.4  89.4  87.4  85.3      |
 |MG/KG FEED |TD                                                                  |
 |           |                                                                    |
 |1 MG/KG    |   100.0 100.0 100.0 100.0  98.6  98.6  96.6  94.5  90.5  78.5      |
 |           |                                                                    |
 |           |                                                                    |
 |5 MG/KG    |   100.0 100.0 100.0 100.0  98.5  98.5  96.4  90.1  88.0  81.8      |
 |           |                                                                    |
 |           |                                                                    |
 |25 MG/KG   |   100.0 100.0 100.0 100.0  97.1  95.7  95.7  91.5  89.4  83.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
                        SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 726 DAYS

 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                           DOSE                                              |
 |                                                                                                                             |
 |                                0 MG/KG            0                  1 MG/KG            5 MG/KG            25 MG/KG         |
 |                                                   MG/KG FEED RTD                                                            |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       81.0%              85.3%              78.5%              81.8%              83.0%            |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=1.000N            -----             P=0.992            P=1.000N           P=1.000N         |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       611.7              244.0              638.2              593.0              572.7            |
 |NATURAL DEATHS (C)      |       (44.8)             ( 111)             (28.4)             (34.6)             (42.5)           |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       632.4              604.8              635.1              613.6              621.6            |
 |(STANDARD ERROR)        |       (15.5)             (28.7)             (14.8)             (18.4)             (15.9)           |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    

       (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)
                        SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 726 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 16     CENSORED DEATHS 21   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      492   511   581   594   604   610   611   611   618   661                 |
 |      679   707   709   712   717   720                                         |
 |  CENSORED DEATHS                                                               |
 |      7     373   457   457   457   457   457   457   457   457                 |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |      457                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0 MG/KG FEED RTD                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 11   TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      464   589   611   617   618   630   686   707   707   709                 |
 |      720   721   723                                                           |
 |  CENSORED DEATHS                                                               |
 |      7     457   457   457   457   457   457   457   457   457                 |
 |      457                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 14     CENSORED DEATHS 20   TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      415   448   482   532   562   590   594   630   676   680                 |
 |      694   705   708   708                                                     |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================
                        SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 726 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 5 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 12     CENSORED DEATHS 21   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      243   302   356   510   578   604   617   647   676   678                 |
 |      685   706                                                                 |
 |  CENSORED DEATHS                                                               |
 |      373   457   457   457   457   457   457   457   457   457                 |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |      457                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 25 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 13     CENSORED DEATHS 19   TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      350   399   432   468   544   551   604   636   670   677                 |
 |      680   691   694                                                           |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |      457   457   457   457   457   457   457   457   457                       |
 |                                                                                |
 ==================================================================================
                        SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 726 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   726 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0 100.0  95.9  89.8  79.6  67.3      |
 |           |                                                                    |
 |           |                                                                    |
 |0          |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  95.9  87.8  73.5      |
 |MG/KG FEED |TD                                                                  |
 |           |                                                                    |
 |1 MG/KG    |   100.0 100.0 100.0 100.0  98.6  95.1  93.1  87.0  85.0  72.9      |
 |           |                                                                    |
 |           |                                                                    |
 |5 MG/KG    |   100.0 100.0  98.6  95.7  95.7  95.7  93.6  89.5  85.3  77.0      |
 |           |                                                                    |
 |           |                                                                    |
 |25 MG/KG   |   100.0 100.0 100.0  98.6  97.1  93.7  91.7  87.7  85.7  75.8      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
                        SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 726 DAYS

 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                           DOSE                                              |
 |                                                                                                                             |
 |                                0 MG/KG            0                  1 MG/KG            5 MG/KG            25 MG/KG         |
 |                                                   MG/KG FEED RTD                                                            |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       67.3%              73.5%              72.9%              77.0%              75.8%            |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.854N            -----             P=0.835N           P=0.571N           P=0.656N         |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       633.6              654.0              601.7              550.2              568.9            |
 |NATURAL DEATHS (C)      |       (17.9)             (21.0)             (27.1)             (46.7)             (33.7)           |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       616.5              653.6              624.3              614.0              623.8            |
 |(STANDARD ERROR)        |       (17.0)             (17.3)             (14.9)             (16.7)             (15.4)           |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    

       (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)
                                                SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        0 MG/KG FEED RTD = 2
                                                        1 MG/KG          = 3
                                                        5 MG/KG          = 4
                                                        25 MG/KG         = 5

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

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

        |
        |
  100.0 +1  2                                          1            4    3
        |
        |                                              1            4    3     1            4  3
        |
   97.5 +
        |                                                                5   5 1               1
        |                                                                                   4  3 4       3
        |                                                                    5                       5
   95.0 +   22                                                                                 1               1
        |                                                                                        4     4 3 3
P       |                                                                                            5 5
E       |                                                                                                      1     1
R  92.5 +                                                                                                  3      3
C       |
E       |    2                                                                               2         5   5
N       |                                                                                                         33
T  90.0 +                                                                                              4 4
        |                                                                                    2           2 5           5
S       |                                                                                                          3 131
U       |                                                                                                4            4
R  87.5 +                                                                                                2             55 2
V       |
I       |                                                                                                             3 3
V       |
A  85.0 +                                                                                                              11 22
L       |
        |                                                                                                             4 4
        |                                                                                                               1  1
   82.5 +
        |                                                                                                               4  4
        |                                                                                                                  1
        |                                                                                                               33
   80.0 +
        |
        |                                                                                                                3 3
        |
   77.5 +
        |
        -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-
         0         10         20         30         40         50         60         70         80         90         100        110

                                                                    WEEK

NOTE: 7 obs hidden.
                                                SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        0 MG/KG FEED RTD = 2
                                                        1 MG/KG          = 3
                                                        5 MG/KG          = 4
                                                        25 MG/KG         = 5

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

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

      |
      |
  100 + 1                                      4               5          3       2   1
      |                                        4        4      5       5  3   3
      |                                                 4       4      5    5 3   2 3 1 1             2
      |                                                         4           5     5     1          1  2  2
   95 +                                                                             3       3
      |                                                                           5     4     5    1  1  22
P     |                                                                                     3    3
E     |                                                                                       55 3 4  1 1
R  90 +                                                                                        5        1122
C     |
E     |                                                                                               3 5 425 4     2
N     |                                                                                                     5     5 2  2
T  85 +                                                                                                    3  4    3
      |                                                                                                  11       55
S     |                                                                                                            33
U     |                                                                                                   1      1 43 322
R  80 +                                                                                                          1 155  22
V     |                                                                                                             4 33
I     |                                                                                                            1 5513 4
V     |                                                                                                               5   5
A  75 +                                                                                                                1122
L     |                                                                                                                   2
      |                                                                                                                 3 3
      |                                                                                                                 11
   70 +
      |
      |                                                                                                                  11
      |
   65 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 19 obs hidden.