National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/2314

TDMS Study 05067-10 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                   THEOPHYLLINE                                     DATE: 07/03/96       
EXPERIMENT: 05067 TEST: 10                                                                                     TIME: 12:27:37       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-05297                              ROUTE: GAVAGE                                                  NTP C#: 61609D       
PATHOLOGIST: ROGER THOMPSON                                                                                    CAS: 58-55-9         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             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: 07/03/96      
EXPERIMENT: 05067 TEST: 10                                                                                     TIME: 12:27:37      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-05297                              ROUTE: GAVAGE                                                  NTP C#: 61609D      
PATHOLOGIST: ROGER THOMPSON                                                                                    CAS: 58-55-9        
                                   THEOPHYLLINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 725 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      438   485   605   627   627   635   635   676   700   700                 |
 |      701   703   704   711                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 15 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      421   464   511   521   522   554   562   569   627   627                 |
 |      633   635   698   706   711                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 50 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 6      CENSORED DEATHS 0    TERMINAL 44        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      556   577   620   668   672   700                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                   THEOPHYLLINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 725 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 150     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      16    32    95    121   184   211   212   282   331   332                 |
 |      334   352   359   359   382   405   407   442   449   481                 |
 |      598   636   636   703                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                   THEOPHYLLINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 725 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   725 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0  96.0  96.0  94.0  86.0  72.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |15 MG/KG   |   100.0 100.0 100.0 100.0  98.0  96.0  90.0  84.0  76.0  70.0      |
 |           |                                                                    |
 |           |                                                                    |
 |50 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  94.0  88.0      |
 |           |                                                                    |
 |           |                                                                    |
 |150        |    96.0  92.0  86.0  72.0  66.0  60.0  60.0  58.0  54.0  52.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      15 MG/KG     50 MG/KG     150      |
 |                                CONTROL                                MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       72.0%        70.0%        88.0%        52.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.001      P=0.838      P=0.090N     P=0.014  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       639.1        584.1        632.2        348.3    |
 |NATURAL DEATHS (C)      |       (22.5)       (22.7)       (23.4)       (37.9)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       700.9        682.7        713.9        544.2    |
 |(STANDARD ERROR)        |       ( 8.2)       (11.4)       ( 5.0)       (32.4)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                   THEOPHYLLINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 725 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      501   555   561   583   605   624   627   642   643   643                 |
 |      654   655   684                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 7.5     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      494   584   591   603   604   611   633   637   644   652                 |
 |      658   687   702                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 25 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      542   593   612   629   655   661   667   668   669   688                 |
 |      696   699   704   704   705   710                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                   THEOPHYLLINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 725 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 75 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      241   242   367   394   526   569   578   627   639   655                 |
 |      658   687   687   702   704   705   719                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                   THEOPHYLLINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 725 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   725 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  90.0  76.0  74.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |7.5        |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  90.0  78.0  74.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |25 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  96.0  88.0  68.0      |
 |           |                                                                    |
 |           |                                                                    |
 |75 MG/KG   |   100.0 100.0  96.0  96.0  92.0  92.0  90.0  86.0  78.0  66.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      7.5          25 MG/KG     75 MG/KG |
 |                                CONTROL      MG/KG                              |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       74.0%        74.0%        68.0%        66.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.407      P=1.000N     P=0.851      P=0.537  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       613.6        623.1        662.6        570.6    |
 |NATURAL DEATHS (C)      |       (14.1)       (14.6)       (11.9)       (39.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       696.0        698.5        705.0        672.5    |
 |(STANDARD ERROR)        |       ( 7.8)       ( 7.4)       ( 5.6)       (16.7)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                                                            THEOPHYLLINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        15 MG/KG         = 2
                                                        50 MG/KG         = 3
                                                        150     MG/KG    = 4

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

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

      |
  100 + 1  4                                                               2 1                  3
      |
      |    4  4                                                            2 1    2  1          3  3
      |       4        4                                                          2  1  2          3    1 3
   95 +
      |                4    4                                                           2  2            1 31      3
      |                     4         4
      |
   90 +                               4   4                                                2    2          11     3   3
      |
      |                                                                                         22                    3   3
      |                                   4          4                                           22         1      1
P  85 +
E     |                                              4       4                                    2        2       1  1
R     |
C     |
E  80 +                                                                                                    22         11
N     |
T     |                                                      4  4
      |                                                         44                                          2         2
S  75 +
U     |                                                                                                               211
R     |                                                          4   4                                                 21 1
V     |
I  70 +                                                              4  4                                               2 2
V     |
A     |                                                                 44
L     |                                                                  4    4
   65 +
      |                                                                       4 4
      |                                                                         4   4
      |
   60 +                                                                             4                  4
      |
      |                                                                                                4    4
      |
   55 +
      |                                                                                                     4          4
      |                                                                                                                4  4
      |
   50 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 5 obs hidden.
                                                            THEOPHYLLINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        7.5     MG/KG    = 2
                                                        25 MG/KG         = 3
                                                        75 MG/KG         = 4

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

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

      |
      |
  100 + 1                                      4                                      21      3
      |
      |                                                                               21      3 1   2 3
      |                                        4                  4                             11  2 2  3
   95 +
      |                                                           4    4                         1  1 2 23 3
P     |                                                                4                    4       1   1  3   3
E     |
R  90 +                                                                                     4     4     12 1   3 3
C     |
E     |                                                                                           44     2  2    33
N     |                                                                                            4       1 1
T  85 +
      |                                                                                                    422
S     |                                                                                                      2 2  3  3
U     |
R  80 +                                                                                                      1 1     33
V     |
I     |                                                                                                        2     2
V     |                                                                                                        1    1232
A  75 +
L     |                                                                                                             14 2  1
      |
      |
   70 +                                                                                                                33
      |
      |                                                                                                                4343
      |                                                                                                                  44
   65 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 14 obs hidden.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.