National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/2721

TDMS Study 05021-03 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 09/03/94   
EXP: 05021                    CI PIGMENT RED 23                TIME: 21:21:31   
TEST: 03              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60377    
CONT: N01ES9565102                                             CAS: 6471-49-4   
PATHOLOGIST: P. HILDEBRANDT                  S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Southern Research Inst                                    DATE: 09/03/94  
EXP: 05021                    CI PIGMENT RED 23                TIME: 21:21:31  
TEST: 03              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60377   
CONT: N01ES9565102                                             CAS: 6471-49-4  
PATHOLOGIST: P. HILDEBRANDT                  S. EUSTIS                         

                                 CI PIGMENT RED 23


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 28     CENSORED DEATHS 10   TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      448   502   513   535   563   564   582   582   585   597                 |
 |      605   612   612   612   612   612   630   631   640   640                 |
 |      655   676   676   681   700   707   709   728                             |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 10   TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      301   477   513   513   557   592   592   592   604   610                 |
 |      644   647   675   681   686   686   699   711   720   723                 |
 |      728                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 14     CENSORED DEATHS 10   TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      479   535   591   591   617   618   620   666   673   674                 |
 |      681   693   711   727                                                     |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   457   457   457                 |
 |                                                                                |
 ==================================================================================

                                 CI PIGMENT RED 23


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 5.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 16     CENSORED DEATHS 9    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      242   412   513   514   612   618   618   629   648   664                 |
 |      676   687   688   696   718   727                                         |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   457   457   457   457   457                       |
 |                                                                                |
 ==================================================================================

                                 CI PIGMENT RED 23


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0 100.0 100.0 100.0 100.0  98.3  92.3  78.3  58.2  44.1      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |1.0%       |   100.0 100.0 100.0  98.3  98.3  96.3  92.3  82.3  76.3  58.2      |
 |           |                                                                    |
 |           |                                                                    |
 |2.5%       |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  92.0  86.0  72.0      |
 |           |                                                                    |
 |           |                                                                    |
 |5.0%       |   100.0 100.0  98.3  98.3  96.7  96.7  92.7  92.7  80.9  69.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATD     1.0%         2.5%         5.0%     |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       44.1%        58.2%        72.0%        69.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.011N     P=0.175N     P=0.005N     P=0.015N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       614.6        616.7        634.0        603.9    |
 |NATURAL DEATHS (C)      |       (12.5)       (22.6)       (18.6)       (32.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       630.2        644.3        661.4        654.8    |
 |(STANDARD ERROR)        |       (13.5)       (15.0)       (13.6)       (15.4)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)

                                 CI PIGMENT RED 23


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 10   TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      249   378   412   494   507   533   578   582   591   591                 |
 |      606   618   648   655   675   676   681   687   693   696                 |
 |      718                                                                       |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   459   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 16     CENSORED DEATHS 10   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      242   407   514   592   612   645   651   673   673   673                 |
 |      673   686   693   697   703   727                                         |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 17     CENSORED DEATHS 10   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      325   457   491   501   546   564   572   595   612   618                 |
 |      631   651   655   662   688   688   693                                   |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   459   459   459   459   459                 |
 |                                                                                |
 ==================================================================================

                                 CI PIGMENT RED 23


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 5.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 10   TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      505   535   592   592   610   618   624   627   627   707                 |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   459   459   459   459   459   459   459                 |
 |                                                                                |
 ==================================================================================

                                 CI PIGMENT RED 23


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0 100.0  98.3  98.3  95.0  95.0  88.9  80.9  72.8  58.6      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |1.0%       |   100.0 100.0  98.3  98.3  96.7  96.7  94.7  92.6  86.6  68.5      |
 |           |                                                                    |
 |           |                                                                    |
 |2.5%       |   100.0 100.0 100.0  98.3  98.3  96.7  92.6  84.6  72.5  66.5      |
 |           |                                                                    |
 |           |                                                                    |
 |5.0%       |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  92.0  82.0  80.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATD     1.0%         2.5%         5.0%     |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       58.6%        68.5%        66.5%        80.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.043N     P=0.306N     P=0.547N     P=0.029N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       584.2        616.3        585.2        603.7    |
 |NATURAL DEATHS (C)      |       (26.3)       (32.1)       (23.8)       (17.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       633.2        653.8        643.2        663.1    |
 |(STANDARD ERROR)        |       (16.1)       (15.4)       (15.0)       (13.6)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                         CI PIGMENT RED 23
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        1.0%             = 2
                                                        2.5%             = 3
                                                        5.0%             = 4

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

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

         |
         |
  104.35 +
         |
         |1                                      4       2                      1     3
         |                                       4       2                 4    1     2  1     3
   96.33 +                                                                 4          2  1 1   3        3
         |                                                                                 1   1
         |                                                                                 2   1  21    3  43
         |                                                                                        2     2  44
P  88.30 +                                                                                         1  1
E        |                                                                                                  34      3
R        |                                                                                              2 2  4  4   33
C        |                                                                                            1  122    4  4
E  80.27 +                                                                                               112   2   4 33
N        |                                                                                                11   22    433
T        |                                                                                                      2    2 3  3
         |                                                                                                           2244 3 3
S  72.24 +                                                                                                              4  43 3
U        |                                                                                                                 44
R        |                                                                                                 1 1        2 2   4 4
V        |                                                                                                   11         2 2
I  64.22 +                                                                                                    11          22
V        |                                                                                                                 22
A        |                                                                                                     1 1
L        |                                                                                                       1   1      2 2
   56.19 +
         |                                                                                                           11
         |                                                                                                            1 1
         |                                                                                                              11
   48.16 +                                                                                                               11
         |                                                                                                                1 1
         |                                                                                                                  1 1
         |
   40.14 +
         |
         -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
          0         10         20         30         40         50         60         70         80         90         100       110

                                                                     WEEK

NOTE: 10 obs hidden.

                                                         CI PIGMENT RED 23
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        1.0%             = 2
                                                        2.5%             = 3
                                                        5.0%             = 4

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

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

      |
      |
  100 + 1                                      21           3                           4
      |                                        21           3      1     2       3
      |                                                                                 4    4
      |                                                            1     1       3    3  2   4        4
   95 +                                                                  1            13 2            2
      |
      |                                                                               131     3       2  2
      |                                                                                 1    13  3       2    2
   90 +                                                                                                  44
      |                                                                                      1   331
P     |                                                                                            11     44
E     |                                                                                           3   3       2    2
R  85 +                                                                                             1 1  3
C     |
E     |                                                                                                  334           4
N     |                                                                                               1 1
T  80 +                                                                                                   3 3          4    4
      |                                                                                                 1 1 3 3    22
S     |
U     |                                                                                                   1   13    22
R  75 +                                                                                                       11 3   22
V     |
I     |                                                                                                        1 3 1 322
V     |
A  70 +                                                                                                                2  2
L     |                                                                                                            11     2 2
      |
      |                                                                                                             11      3
   65 +
      |
      |                                                                                                              11
      |                                                                                                               1  1
   60 +
      |                                                                                                                  1  1
      |
      |
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 11 obs hidden.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.