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TDMS Study 05067-09 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                   THEOPHYLLINE                                     DATE: 07/11/96       
EXPERIMENT: 05067 TEST: 09                                                                                     TIME: 17:51:19       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-05297                              ROUTE: GAVAGE                                                  NTP C#: 61609D       
PATHOLOGIST: DANIEL FARNELL                  FARNELL, DANIEL R.                                                CAS: 58-55-9         
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                                                             CORE STUDY                                                             
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Southern Research Inst                                   THEOPHYLLINE                                     DATE: 07/11/96      
EXPERIMENT: 05067 TEST: 09                                                                                     TIME: 17:51:19      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-05297                              ROUTE: GAVAGE                                                  NTP C#: 61609D      
PATHOLOGIST: DANIEL FARNELL                  FARNELL, DANIEL R.                                                CAS: 58-55-9        
                                   THEOPHYLLINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 26     CENSORED DEATHS 1    TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      529   533   545   546   572   598   607   614   616   617                 |
 |      617   638   638   642   649   649   658   670   670   671                 |
 |      671   700   719   726   727   728                                         |
 |  CENSORED DEATHS                                                               |
 |      388                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 7.5     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 1    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      372   497   500   547   558   566   616   616   624   644                 |
 |      666   667   706   713   719   723                                         |
 |  CENSORED DEATHS                                                               |
 |      234                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 25 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 1    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      233   422   425   498   498   520   558   558   560   572                 |
 |      590   616   617   622   639   647   666   670   680   706                 |
 |  CENSORED DEATHS                                                               |
 |      526                                                                       |
 |                                                                                |
 ==================================================================================
                                   THEOPHYLLINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 75 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 26     CENSORED DEATHS 0    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      211   241   306   387   387   441   456   457   457   457                 |
 |      457   457   462   497   498   552   566   572   576   595                 |
 |      642   643   649   671   706   706                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                   THEOPHYLLINE

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

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0 100.0  93.9  87.8  65.3  46.9      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |7.5        |   100.0 100.0 100.0 100.0  98.0  98.0  93.9  87.8  79.6  67.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |25 MG/KG   |   100.0 100.0  98.0  98.0  94.0  94.0  88.0  77.8  67.5  59.3      |
 |           |                                                                    |
 |           |                                                                    |
 |75 MG/KG   |   100.0 100.0  96.0  94.0  90.0  74.0  70.0  60.0  54.0  48.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      7.5          25 MG/KG     75 MG/KG |
 |                                CONTROL      MG/KG                              |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       46.9%        67.3%        59.3%        48.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.118      P=0.084N     P=0.526N     P=0.586  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       636.5        608.4        564.9        501.9    |
 |NATURAL DEATHS (C)      |       (11.6)       (24.4)       (25.0)       (25.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       674.1        680.5        659.3        610.9    |
 |(STANDARD ERROR)        |       (10.6)       (14.3)       (15.3)       (21.0)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                   THEOPHYLLINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      399   441   498   498   524   533   545   576   580   630                 |
 |      667   667   670   670   678   691   719   720                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 7.5     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 1    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      5     404   478   504   579   595   598   600   600   614                 |
 |      614   614   646   651   670   691   692   694   700                       |
 |  CENSORED DEATHS                                                               |
 |      293                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 25 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      497   498   520   531   541   551   601   617   642   649                 |
 |      661   663   670   671   674   719   723                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                   THEOPHYLLINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 75 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 3    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      393   421   586   614   614   614   642   648   660   671                 |
 |      691   695   695   706                                                     |
 |  CENSORED DEATHS                                                               |
 |      244   244   336                                                           |
 |                                                                                |
 ==================================================================================
                                   THEOPHYLLINE

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

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0  98.0  96.0  86.0  82.0  80.0  64.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |7.5        |    98.0  98.0  98.0  98.0  96.0  93.9  91.9  81.7  71.5  61.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |25 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  90.0  86.0  76.0  66.0      |
 |           |                                                                    |
 |           |                                                                    |
 |75 MG/KG   |   100.0 100.0 100.0 100.0  95.7  95.7  95.7  93.6  80.9  70.2      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      7.5          25 MG/KG     75 MG/KG |
 |                                CONTROL      MG/KG                              |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       64.0%        61.3%        66.0%        70.2%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.389N     P=0.916      P=0.955N     P=0.584N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       594.8        576.3        613.4        617.9    |
 |NATURAL DEATHS (C)      |       (23.1)       (36.4)       (18.4)       (25.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       680.7        662.2        689.7        670.6    |
 |(STANDARD ERROR)        |       (12.3)       (18.8)       ( 9.9)       (17.5)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                            THEOPHYLLINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        7.5     MG/KG    = 2
                                                        25 MG/KG         = 3
                                                        75 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       3          2     11
      |                                        4        4             4    3          22     112
      |                                                                                       122 1
P  90 +                                                               4      4         3   3    221    1
E     |                                                                      4   4         3    32     112
R     |                                                                                                 11
C     |                                                                                         3 3      112 2
E  80 +                                                                                           3   3      2    2
N     |                                                                                               3  31  1
T     |                                                                          4    4                  33       2    2
      |                                                                               44                  3  11        222
S  70 +                                                                                4       4             33          22
U     |                                                                                        4 4            11  3       2 2
R     |                                                                                          444           1  1
V     |                                                                                            4  4           3 3  3
I  60 +                                                                                               4      4         3    3
V     |                                                                                                           1   1
A     |                                                                                                      44   4   1  1
L     |                                                                                                           4    4 11
   50 +
      |                                                                                                                4  1 1
      |
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 15 obs hidden.
                                                            THEOPHYLLINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        7.5     MG/KG    = 2
                                                        25 MG/KG         = 3
                                                        75 MG/KG         = 4

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

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

      |
      |
  100 + 12                                                             1              3
      |
      |  2                                                             12  4 1        33
      |                                                                 2  4 1      2  1   3        4
   95 +
      |                                                                             2  2   33       4    4
      |                                                                                1   13 3    2
      |
P  90 +                                                                                    1 133   2  2
E     |
R     |                                                                                      113      22 4   4
C     |                                                                                       1    1   3  3
E  85 +                                                                                                      44
N     |                                                                                                   3  3
T     |                                                                                            1       1 33  4
      |                                                                                                2 2       44
S  80 +                                                                                                    1  3  31
U     |                                                                                                           4  4
R     |
V     |                                                                                                          33  44
I  75 +                                                                                                  2    2
V     |
A     |                                                                                                           11  44
L     |                                                                                                       2   2
   70 +                                                                                                           21 1 4 3  4
      |
      |                                                                                                              1   13
      |                                                                                                                   3 3
   65 +                                                                                                              22
      |                                                                                                                  1  1
      |
      |                                                                                                               2     2
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 14 obs hidden.