National Toxicology Program

National Toxicology Program
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TR 364 Mouse Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 09/07/94   
EXP: 05048                       RHODAMINE 6G                  TIME: 01:51:04   
TEST: 02              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 56122    
CONT: N01-ES-28024                                             CAS: 989-38-8    
PATHOLOGIST: R. THOMPSON                                                        
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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Southern Research Inst                                    DATE: 09/07/94  
EXP: 05048                       RHODAMINE 6G                  TIME: 01:51:04  
TEST: 02              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 56122   
CONT: N01-ES-28024                                             CAS: 989-38-8   
PATHOLOGIST: R. THOMPSON                                                       

                                   RHODAMINE 6G


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      90    474   546   579   620   634   639   664   664   664                 |
 |      667   705   705   708                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.1%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 1    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      431   479   483   502   573   621   625   635   638   645                 |
 |      663   664   666   698   707   707   727                                   |
 |  CENSORED DEATHS                                                               |
 |      544                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.2%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      374   385   392   395   433   439   522   698   699   699                 |
 |      705   706                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                   RHODAMINE 6G


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       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   |    98.0  98.0  98.0  98.0  98.0  96.0  96.0  92.0  80.0  72.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.1%       |   100.0 100.0 100.0 100.0 100.0  94.0  92.0  90.0  75.6  65.4      |
 |           |                                                                    |
 |           |                                                                    |
 |0.2%       |   100.0 100.0 100.0 100.0  92.0  88.0  86.0  86.0  86.0  76.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                UNTREATD         0.1%             0.2%          |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       72.0%            65.4%            76.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.804N         P=0.588          P=0.863N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       597.1            615.5            537.3         |
 |NATURAL DEATHS (C)      |       (42.8)           (21.9)           (43.2)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       692.1            686.7            683.0         |
 |(STANDARD ERROR)        |       (14.4)           (10.9)           (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)

                                   RHODAMINE 6G


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      570   591   630   655   663   664   682   693   695   721                 |
 |      724                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.05%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      440   546   576   581   640   649   666   666   667   677                 |
 |      693   699   706   709   725                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.1%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      459   583   599   613   635   638   642   686   694   695                 |
 |      695   698   725   728                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                   RHODAMINE 6G


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       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   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  88.0  78.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.05%      |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  92.0  88.0  70.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.1%       |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  94.0  86.0  72.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                UNTREATD         0.05%            0.1%          |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       78.0%            70.0%            72.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.569          P=0.467          P=0.630       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       662.5            642.7            649.3         |
 |NATURAL DEATHS (C)      |       (14.9)           (19.8)           (19.1)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       714.4            703.1            706.7         |
 |(STANDARD ERROR)        |       ( 5.0)           ( 8.1)           ( 7.3)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                            RHODAMINE 6G
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        0.1%             = 2
                                                        0.2%             = 3

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

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

      |
      |
  100 + 1             1                                            3        2
      |
      |               1                                            3 3      2      12
      |                                                              33            1          1
   95 +
      |                                                               33            2  2      1    1
P     |                                                                3    3          2          21      1
E     |
R  90 +                                                                     33                    2       1 1
C     |
E     |                                                                      3             3              2211
N     |                                                                                    3               221   1    3
T  85 +
      |                                                                                                     22
S     |
U     |                                                                                                      22
R  80 +                                                                                                       2  11   33
V     |
I     |                                                                                                           1    1
V     |                                                                                                          22    3    3
A  75 +
L     |                                                                                                           2   211
      |                                                                                                                 1   1
      |                                                                                                               22
   70 +
      |
      |                                                                                                                2  2
      |
   65 +                                                                                                                   2 2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 4 obs hidden.

                                                            RHODAMINE 6G
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        0.05%            = 2
                                                        0.1%             = 3

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

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

      |
      |
  100 + 1                                                                    2   3                1
      |
      |                                                                      2   3            2   1 3 1
      |
   96 +                                                                                       2    23 13   1
      |
      |                                                                                                3 3 1   1
      |
P  92 +                                                                                            2     3  32 1 1
E     |
R     |                                                                                                     322
C     |
E  88 +                                                                                                       2  12 1
N     |
T     |                                                                                                      3      11
      |
S  84 +                                                                                                             311
U     |
R     |                                                                                                           22  1  1
V     |
I  80 +                                                                                                            2 2   11
V     |
A     |                                                                                                              22   1 1
L     |
   76 +                                                                                                               22  3
      |
      |                                                                                                                22
      |
   72 +                                                                                                                 2 2 3
      |
      |                                                                                                                   2 2
      |
   68 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 7 obs hidden.

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