National Toxicology Program

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TDMS Study 05128-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                D & C YELLOW NO. 11                                 DATE: 04/03/96       
EXPERIMENT: 05128 TEST: 06                                                                                     TIME: 23:52:11       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-95271                              ROUTE: DOSED FEED                                              NTP C#: 61789B       
PATHOLOGIST: J. E. HEATH                                                                                       CAS: 8003-22-3       
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Southern Research Inst                                D & C YELLOW NO. 11                                 DATE: 04/03/96      
EXPERIMENT: 05128 TEST: 06                                                                                     TIME: 23:52:11      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-95271                              ROUTE: DOSED FEED                                              NTP C#: 61789B      
PATHOLOGIST: J. E. HEATH                                                                                       CAS: 8003-22-3      
                                D & C YELLOW NO. 11

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATDCONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 31     CENSORED DEATHS 10   TERMINAL 19        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      481   509   530   590   600   615   619   621   622   623                 |
 |      628   632   632   637   638   650   656   656   667   677                 |
 |      688   693   695   695   701   702   706   706   716   719                 |
 |      722                                                                       |
 |  CENSORED DEATHS                                                               |
 |      357   357   357   357   357   357   357   357   357   357                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.05%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 31     CENSORED DEATHS 9    TERMINAL 20        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      222   509   509   510   545   546   558   558   560   570                 |
 |      575   586   593   602   611   628   628   642   656   656                 |
 |      658   672   677   688   695   712   716   719   719   726                 |
 |      727                                                                       |
 |  CENSORED DEATHS                                                               |
 |      357   357   357   357   357   357   357   357   357                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.17%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 59     UNCENSORED DEATHS 42     CENSORED DEATHS 9    TERMINAL 8         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      246   384   406   453   468   491   499   502   551   590                 |
 |      600   600   607   610   615   631   646   646   649   649                 |
 |      649   650   650   659   663   663   667   672   680   686                 |
 |      686   686   686   692   695   695   695   706   712   714                 |
 |      719   727                                                                 |
 |  CENSORED DEATHS                                                               |
 |      357   357   357   357   357   357   357   357   357                       |
 |                                                                                |
 ==================================================================================
                                D & C YELLOW NO. 11

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 52     CENSORED DEATHS 6    TERMINAL 2         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      302   320   345   345   370   432   481   492   496   498                 |
 |      498   498   502   505   509   510   534   546   563   566                 |
 |      568   572   589   590   596   596   602   615   617   624                 |
 |      624   629   656   656   658   678   678   690   691   693                 |
 |      695   695   695   700   700   704   706   716   716   722                 |
 |      726   727                                                                 |
 |  CENSORED DEATHS                                                               |
 |      357   357   357   357   357   357                                         |
 |                                                                                |
 ==================================================================================
                                D & C YELLOW NO. 11

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   733 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATDCON|ROL100.0 100.0 100.0 100.0 100.0  98.0  94.0  90.0  64.0  38.0      |
 |U          |                                                                    |
 |           |                                                                    |
 |0.05%      |   100.0 100.0  98.3  98.3  98.3  98.3  90.5  72.8  59.0  39.3      |
 |           |                                                                    |
 |           |                                                                    |
 |0.17%      |   100.0 100.0  98.3  98.3  94.3  90.3  84.3  76.2  48.1  16.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5%       |   100.0 100.0 100.0  93.3  91.5  87.7  69.1  50.4  35.5   3.7      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATDCONTR0.05%        0.17%        0.5%     |
 |                                U                                               |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       38.0%        39.3%        16.0%         3.7%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.974      P=0.013      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       646.0        612.0        616.5        585.3    |
 |NATURAL DEATHS (C)      |       (10.8)       (18.1)       (16.1)       (15.9)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       625.4        614.1        592.7        567.4    |
 |(STANDARD ERROR)        |       (17.3)       (18.3)       (18.2)       (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)
                                D & C YELLOW NO. 11

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 740 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATDCONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 28     CENSORED DEATHS 10   TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      481   537   570   572   572   589   589   602   607   629                 |
 |      650   651   656   660   671   684   699   700   701   712                 |
 |      719   722   729   730   730   734   734   734                             |
 |  CENSORED DEATHS                                                               |
 |      358   358   358   358   358   358   358   358   358   358                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.05%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 25     CENSORED DEATHS 9    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      308   462   546   548   600   601   622   622   628   629                 |
 |      631   631   642   645   656   672   688   688   693   695                 |
 |      705   712   716   726   734                                               |
 |  CENSORED DEATHS                                                               |
 |      358   358   358   358   358   358   358   358   358                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.17%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 10   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      456   532   588   597   610   638   658   660   671   701                 |
 |      719   722   722                                                           |
 |  CENSORED DEATHS                                                               |
 |      358   358   358   358   358   358   358   358   358   358                 |
 |                                                                                |
 ==================================================================================
                                D & C YELLOW NO. 11

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 740 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 28     CENSORED DEATHS 9    TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      147   441   448   469   506   530   568   590   596   648                 |
 |      656   656   658   658   672   695   700   712   720   723                 |
 |      723   728   728   728   729   729   733   734                             |
 |  CENSORED DEATHS                                                               |
 |      358   358   358   358   358   358   358   358   358                       |
 |                                                                                |
 ==================================================================================
                                D & C YELLOW NO. 11

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 740 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   740 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATDCON|ROL100.0 100.0 100.0 100.0 100.0  98.0  96.0  84.0  72.0  44.0      |
 |U          |                                                                    |
 |           |                                                                    |
 |0.05%      |   100.0 100.0 100.0  98.3  98.3  96.4  96.4  88.5  70.8  51.1      |
 |           |                                                                    |
 |           |                                                                    |
 |0.17%      |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  92.0  84.0  74.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5%       |   100.0  98.3  98.3  98.3  98.3  92.4  88.5  82.6  72.8  45.2      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATDCONTR0.05%        0.17%        0.5%     |
 |                                U                                               |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       44.0%        51.1%        74.0%        45.2%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.882      P=0.769N     P=0.006N     P=1.000N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       655.9        632.0        636.5        629.5    |
 |NATURAL DEATHS (C)      |       (13.3)       (18.5)       (22.1)       (25.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       637.1        637.7        653.9        631.1    |
 |(STANDARD ERROR)        |       (18.1)       (18.3)       (18.6)       (20.0)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                                                        D & C YELLOW NO. 11
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATDCONTROL  = 1
                                                        0.05%            = 2
                                                        0.17%            = 3
                                                        0.5%             = 4

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

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

      |
  100 + 1                                  2    3       4                           1
      |                                    2    3       4  4   4     3  3           1   1
      |                                                                 3       3       1   1         1
      |                                                        4  4         4   3 3     2     2       11
   90 +                                                                     4     3 4 3                1 1
      |                                                                             4 33      2 2        11
      |                                                                               43       3
      |                                                                                        32 2   3
   80 +                                                                                           22  33  11
      |                                                                                44          22 2    11
      |                                                                                               2233
      |                                                                                                2 2  11
P  70 +                                                                                 4    44          2 2311
E     |                                                                                       4  4         23211
R     |                                                                                                      2 1  1
C     |                                                                                          44               11
E  60 +                                                                                           4   4        2  21 1
N     |                                                                                                           22
T     |                                                                                               44      3  3 2 11
      |                                                                                                              211
S  50 +                                                                                                4 4            2 22
U     |                                                                                                  444     33
R     |                                                                                                           3 3  1 1
V     |                                                                                                                  22
I  40 +                                                                                                    4   4         11 2
V     |                                                                                                                   1 1
A     |                                                                                                        4   433
L     |                                                                                                            4 33
   30 +
      |
      |                                                                                                              4333
      |
   20 +                                                                                                                 33
      |                                                                                                               44 33
      |                                                                                                                   3 3
      |                                                                                                                4 4
   10 +                                                                                                                  44
      |
      |
      |                                                                                                                   4 4
    0 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 25 obs hidden.
                                                        D & C YELLOW NO. 11
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATDCONTROL  = 1
                                                        0.05%            = 2
                                                        0.17%            = 3
                                                        0.5%             = 4

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

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

      |
      |
  100 + 1                      4                        2                        3  1
      |                        4                        2                    44  2  1       312
      |                                                                       4   4         3122  1 3  3
      |                                                                           4     4      2       2 3
P  90 +                                                                                 4   4     1   1  3   3
E     |                                                                                     4     4   42  2  3 3
R     |                                                                                               111 22   3 33
C     |                                                                                                41  1  4   3    3
E  80 +                                                                                                    12 14       3 3
N     |                                                                                                     22           33
T     |                                                                                                      211 1        3  3
      |                                                                                                       22 11
S  70 +                                                                                                        2  1 124
U     |                                                                                                             1 1 4
R     |                                                                                                               1144
V     |                                                                                                              221144
I  60 +                                                                                                               2211
V     |                                                                                                                 211
A     |                                                                                                                  21 1
L     |                                                                                                                   2 2
   50 +                                                                                                                     22
      |
      |                                                                                                                     11
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 31 obs hidden.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.