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TDMS Study 05156-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                COBALT SULFATE HEPTAHYDRATE                             DATE: 07/25/96       
EXPERIMENT: 05156 TEST: 05                                                                                     TIME: 11:39:04       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-05287                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 61530B       
PATHOLOGIST: GRUMBEIN, S.                                                                                      CAS: 10026-24-1      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             CORE STUDY                                                             
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Northwest                                COBALT SULFATE HEPTAHYDRATE                             DATE: 07/25/96      
EXPERIMENT: 05156 TEST: 05                                                                                     TIME: 11:39:04      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-05287                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 61530B      
PATHOLOGIST: GRUMBEIN, S.                                                                                      CAS: 10026-24-1     
                            COBALT SULFATE HEPTAHYDRATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 734 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 33     CENSORED DEATHS 0    TERMINAL 17        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      435   453   526   526   527   534   548   568   576   579                 |
 |      582   589   593   602   602   603   605   610   610   610                 |
 |      619   631   632   643   645   649   664   673   679   680                 |
 |      691   692   727                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.3     MG/M3                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 35     CENSORED DEATHS 0    TERMINAL 15        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      408   471   475   495   541   554   576   579   589   589                 |
 |      600   610   629   629   631   631   632   638   638   645                 |
 |      646   649   652   663   669   671   678   680   680   681                 |
 |      691   694   701   719   722                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 1.0     MG/M3                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 29     CENSORED DEATHS 0    TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      272   435   467   509   518   526   534   581   582   611                 |
 |      611   630   631   632   642   649   652   654   657   671                 |
 |      673   673   678   681   694   699   709   713   729                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                            COBALT SULFATE HEPTAHYDRATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 734 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 3.0     MG/M3                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 35     CENSORED DEATHS 0    TERMINAL 15        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      401   463   463   511   526   534   545   562   562   567                 |
 |      574   579   586   589   593   603   604   611   611   611                 |
 |      632   638   638   643   646   663   666   669   673   680                 |
 |      692   693   694   706   720                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                            COBALT SULFATE HEPTAHYDRATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 734 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   734 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0  96.0  88.0  66.0  46.0  34.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.3        |   100.0 100.0 100.0 100.0  98.0  94.0  90.0  78.0  52.0  30.0      |
 |MG/M3      |                                                                    |
 |           |                                                                    |
 |1.0        |   100.0 100.0 100.0  98.0  98.0  94.0  86.0  82.0  62.0  42.0      |
 |MG/M3      |                                                                    |
 |           |                                                                    |
 |3.0        |   100.0 100.0 100.0 100.0  98.0  94.0  86.0  66.0  48.0  30.0      |
 |MG/M3      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      0.3          1.0          3.0      |
 |                                             MG/M3        MG/M3        MG/M3    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       34.0%        30.0%        42.0%        30.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.723      P=1.000N     P=0.292N     P=0.876  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       603.1        621.6        610.8        604.2    |
 |NATURAL DEATHS (C)      |       (11.4)       (12.4)       (18.5)       (12.5)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       647.6        655.3        662.5        643.2    |
 |(STANDARD ERROR)        |       (11.6)       (11.4)       (13.8)       (12.2)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                            COBALT SULFATE HEPTAHYDRATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 735 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      385   569   572   582   582   602   610   632   638   666                 |
 |      679   692   694   705   709   709   719   721   727   727                 |
 |      733   733                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.3     MG/M3                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 49     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      362   420   483   491   517   526   526   585   610   610                 |
 |      610   652   670   673   673   687   694   702   709   709                 |
 |      714   722   728   731                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 1.0     MG/M3                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      355   510   526   541   568   596   600   603   619   632                 |
 |      652   659   685   692   694   695   709   722   722   722                 |
 |      723   727   729   732                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                            COBALT SULFATE HEPTAHYDRATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 735 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 3.0     MG/M3                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      6     386   470   585   610   611   632   642   650   652                 |
 |      663   673   679   680   686   692   693   709   709   722                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                            COBALT SULFATE HEPTAHYDRATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 735 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   735 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0  98.0  98.0  98.0  88.0  82.0  56.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.3        |   100.0 100.0 100.0  98.0  95.9  93.9  85.7  83.7  75.5  51.0      |
 |MG/M3      |                                                                    |
 |           |                                                                    |
 |1.0        |   100.0 100.0 100.0  98.0  98.0  98.0  92.0  84.0  76.0  52.0      |
 |MG/M3      |                                                                    |
 |           |                                                                    |
 |3.0        |    98.0  98.0  98.0  98.0  96.0  94.0  94.0  92.0  78.0  60.0      |
 |MG/M3      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      0.3          1.0          3.0      |
 |                                             MG/M3        MG/M3        MG/M3    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       56.0%        51.0%        52.0%        60.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.642N     P=0.583      P=0.756      P=0.959N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       653.9        616.8        642.2        607.5    |
 |NATURAL DEATHS (C)      |       (17.8)       (21.6)       (19.0)       (36.6)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       699.3        677.1        690.5        684.0    |
 |(STANDARD ERROR)        |       ( 9.6)       (13.5)       (11.2)       (16.9)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                    COBALT SULFATE HEPTAHYDRATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        0.3     MG/M3    = 2
                                                        1.0     MG/M3    = 3
                                                        3.0     MG/M3    = 4

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

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

      |
  104 +
      |
      | 1                                          3                    42   1
      |                                            3                    42   1  1 42
   96 +                                                                      3  1 3         1
      |                                                                           32  2 3
      |                                                                               2 33  4 2
      |                                                                                  3  112 2
   88 +                                                                                     31412  2
      |                                                                                      341 413
      |                                                                                           113 2
      |                                                                                             3    3
P  80 +                                                                                          4411 22
E     |                                                                                           441 12 2 3
R     |                                                                                            44    2 23
C     |                                                                                             4 11
E  72 +                                                                                                    223
N     |                                                                                               411    33
T     |                                                                                                       33
      |                                                                                                 11  22
S  64 +
U     |                                                                                                      223  3
R     |                                                                                                  11 4     33
V     |                                                                                                   1 14
I  56 +                                                                                                       22
V     |                                                                                                     11 2 2 33
A     |                                                                                                      11  22 3 3
L     |                                                                                                       4  4
   48 +                                                                                                       1  122  3 3
      |                                                                                                          1 12
      |                                                                                                           44    3   3
      |                                                                                                            11       3
   40 +                                                                                                             11
      |                                                                                                              22
      |                                                                                                              122  1
      |                                                                                                               42 21 1
   32 +                                                                                                                4 22
      |                                                                                                                  42 2
      |
      |
   24 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 39 obs hidden.
                                                    COBALT SULFATE HEPTAHYDRATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        0.3     MG/M3    = 2
                                                        1.0     MG/M3    = 3
                                                        3.0     MG/M3    = 4

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

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

      |
  100 + 14                                                      32   1
      |
      |  4                                                      32   14   2             3         1
      |                                                               4   2        42   3   3
   95 +
      |                                                                            42 2     3 3   1 1
      |                                                                                       3   3 4    4
      |                                                                               2  2
   90 +                                                                                  2  2     3 1  1
      |
      |                                                                                                1 1  4
      |                                                                                     2       2  331  14
P  85 +
E     |                                                                                             2   323 114
R     |                                                                                                   3 3144  1
C     |
E  80 +                                                                                                     3  3 411
N     |
T     |                                                                                                  2     2 3 1 1
      |                                                                                                          3  311
S  75 +                                                                                                        2  2
U     |                                                                                                           223311
R     |                                                                                                              3311
V     |
I  70 +                                                                                                            242
V     |
A     |                                                                                                              22 11
L     |                                                                                                              4  3 3
   65 +                                                                                                               22
      |                                                                                                                2211
      |                                                                                                                 4 4
      |
   60 +                                                                                                                   1 1
      |
      |                                                                                                                 2 2
      |                                                                                                                   3 1
   55 +
      |
      |                                                                                                                   2 2
      |                                                                                                                     2
   50 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 22 obs hidden.