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TDMS Study 05121-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                             SCOPOLAMINE HYDROBROMIDE TRIHYDRATE                         DATE: 04/03/96       
EXPERIMENT: 05121 TEST: 05                                                                                     TIME: 21:44:21       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01 ES 85227                              ROUTE: GAVAGE                                                  NTP C#: 03098C       
PATHOLOGIST: M. RYAN                                                                                           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: 05                                                                                     TIME: 21:44:21      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01 ES 85227                              ROUTE: GAVAGE                                                  NTP C#: 03098C      
PATHOLOGIST: M. RYAN                                                                                           CAS: 6533-68-2      
                        SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = O MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 28     CENSORED DEATHS 12   TERMINAL 20        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      430   443   471   492   508   523   581   600   639   642                 |
 |      645   649   655   656   656   660   663   671   673   686                 |
 |      686   698   702   702   706   713   720   720                             |
 |  CENSORED DEATHS                                                               |
 |      273   456   456   456   456   456   456   456   456   456                 |
 |      456   566                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 34     CENSORED DEATHS 12   TERMINAL 14        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      404   446   492   504   504   533   533   540   560   583                 |
 |      585   589   592   612   631   632   656   658   660   660                 |
 |      666   669   671   678   678   678   688   688   702   702                 |
 |      702   706   713   715                                                     |
 |  CENSORED DEATHS                                                               |
 |      281   456   456   456   456   456   456   456   456   456                 |
 |      456   561                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 5 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 27     CENSORED DEATHS 11   TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      178   463   565   576   576   589   596   609   625   627                 |
 |      631   631   643   646   646   649   656   660   666   673                 |
 |      681   686   686   686   706   713   713                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |      631                                                                       |
 |                                                                                |
 ==================================================================================
                        SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 25 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 11   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      144   351   404   504   516   540   565   575   584   589                 |
 |      589   656   666   673   673   679   684   685   686   692                 |
 |      713                                                                       |
 |  CENSORED DEATHS                                                               |
 |      126   456   456   456   456   456   456   456   456   456                 |
 |      456                                                                       |
 |                                                                                |
 ==================================================================================
                        SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |O MG/KG    |   100.0 100.0 100.0 100.0 100.0  94.6  88.4  84.2  65.2  42.1      |
 |           |                                                                    |
 |           |                                                                    |
 |1 MG/KG    |   100.0 100.0 100.0 100.0  98.3  96.6  84.3  73.8  59.0  29.5      |
 |           |                                                                    |
 |           |                                                                    |
 |5 MG/KG    |   100.0  98.3  98.3  98.3  98.3  96.3  96.3  86.3  63.9  45.3      |
 |           |                                                                    |
 |           |                                                                    |
 |25 MG/KG   |   100.0  98.3  98.3  96.6  94.9  94.9  88.7  78.4  76.3  57.8      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       42.1%        29.5%        45.3%        57.8%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.057N     P=0.219      P=0.995N     P=0.274N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       628.2        618.5        621.3        579.4    |
 |NATURAL DEATHS (C)      |       (16.6)       (14.2)       (20.0)       (30.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       625.2        609.9        632.3        619.7    |
 |(STANDARD ERROR)        |       (15.3)       (14.7)       (14.9)       (18.8)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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 RATS
                       FIRST TERMINAL SACRIFICE AT 726 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = O MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 16     CENSORED DEATHS 10   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      374   437   461   463   562   562   582   611   611   627                 |
 |      658   660   663   671   685   693                                         |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 25     CENSORED DEATHS 18   TERMINAL 17        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      239   299   357   358   377   379   408   422   463   463                 |
 |      467   517   519   541   544   562   562   572   581   603                 |
 |      624   628   628   635   635                                               |
 |  CENSORED DEATHS                                                               |
 |      178   204   204   204   204   204   204   204   204   204                 |
 |      204   204   204   204   204   204   204   379                             |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 5 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 12   TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      237   325   373   404   467   471   547   547   555   600                 |
 |      622   622   631   632   645   653   680   697   700   707                 |
 |      708   709                                                                 |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |      652   700                                                                 |
 |                                                                                |
 ==================================================================================
                        SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 25 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 23     CENSORED DEATHS 15   TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      41    58    190   291   332   332   346   372   391   392                 |
 |      394   473   485   502   520   570   576   590   603   607                 |
 |      629   647   663                                                           |
 |  CENSORED DEATHS                                                               |
 |      178   254   336   457   457   457   457   457   457   457                 |
 |      457   457   457   498   499                                               |
 |                                                                                |
 ==================================================================================
                        SCOPOLAMINE HYDROBROMIDE TRIHYDRATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |O MG/KG    |   100.0 100.0 100.0 100.0  98.3  92.6  92.6  86.6  74.5  68.5      |
 |           |                                                                    |
 |           |                                                                    |
 |1 MG/KG    |   100.0 100.0  97.7  90.7  81.3  74.1  64.5  52.6  40.6  40.6      |
 |           |                                                                    |
 |           |                                                                    |
 |5 MG/KG    |   100.0 100.0  98.3  96.7  93.3  89.3  89.3  81.2  68.9  56.2      |
 |           |                                                                    |
 |           |                                                                    |
 |25 MG/KG   |    96.7  96.7  95.0  88.0  81.0  76.5  71.7  62.1  52.6  52.6      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                O MG/KG      1 MG/KG      5 MG/KG      25 MG/KG |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       68.5%        40.6%        56.2%        52.6%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.311      P=0.002      P=0.286      P=0.041  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       582.5        495.3        569.6        435.0    |
 |NATURAL DEATHS (C)      |       (24.7)       (22.9)       (29.0)       (36.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       642.9        475.8        622.2        538.5    |
 |(STANDARD ERROR)        |       (14.9)       (27.5)       (16.9)       (23.9)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        O MG/KG          = 1
                                                        1 MG/KG          = 2
                                                        5 MG/KG          = 3
                                                        25 MG/KG         = 4

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

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

      |
      |
  100 + 1                      4     3                                  2   1
      |                        4     3                          4       2   1 1   31  2          3
      |                                                                 4          1  12         3 3
      |                                                                               1414
   90 +                                                                                214 1 24    3  3
      |                                                                                    1 22  4 1  313
P     |                                                                                       2 2  44  13  3 1
E     |                                                                                         2   2 4
R  80 +                                                                                                    3311
C     |                                                                                             2 2     33 4  4
E     |                                                                                               2  2   311  44
N     |                                                                                                  2  2
T  70 +                                                                                                        1 1
      |                                                                                                     2 32   44
S     |                                                                                                        3 11
U     |                                                                                                        2 21144
R  60 +                                                                                                          22114  4
V     |                                                                                                             1 1 4 4
I     |                                                                                                               11
V     |                                                                                                           223  3
A  50 +                                                                                                                33
L     |                                                                                                            2 2 111
      |                                                                                                                 3 3
      |                                                                                                              2 2 11
   40 +
      |
      |
      |                                                                                                                222
   30 +                                                                                                                  22
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 31 obs hidden.
                                                SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        O MG/KG          = 1
                                                        1 MG/KG          = 2
                                                        5 MG/KG          = 3
                                                        25 MG/KG         = 4

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

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

      |
      |
  100 + 1      4                             3 2                   1
      |        4  4                    4     3 2       2    3      1         1   1
      |                                4              42        2  3    3        11
      |                                               4      4  22      3         13             1
P  90 +                                                      4 4 2 2               3           3
E     |                                                        4   2 24                          1  1    1
R     |                                                              2   2                     33
C     |                                                               44 2 2      2             3      3 1 1
E  80 +                                                                4           4                   3  31   1
N     |                                                                            4 4 4                  3 3  1 1
T     |                                                                           2    4 2 4                     11
      |                                                                                  2 2      4         3 3   1 1
S  70 +                                                                                    2  2   44          33    11
U     |                                                                                            4  4             313   1
R     |                                                                                       2  2    4 4
V     |                                                                                                               33
I  60 +                                                                                          22     4  4           33
V     |                                                                                           22       4  4
A     |                                                                                            2    2     4  4      3 3
L     |                                                                                                 2  2     4        4
   50 +
      |
      |                                                                                                    22
      |
   40 +                                                                                                     2             2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 17 obs hidden.