National Toxicology Program

National Toxicology Program
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TR 341 Mouse Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 09/07/94   
EXP: 05051                     NITROFURANTOIN                  TIME: 14:53:11   
TEST: 02              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: C55196   
CONT: NOIES28024                                               CAS: 67-20-9     
PATHOLOGIST: H. GILES                                                           
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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Southern Research Inst                                    DATE: 09/07/94  
EXP: 05051                     NITROFURANTOIN                  TIME: 14:53:11  
TEST: 02              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: C55196  
CONT: NOIES28024                                               CAS: 67-20-9    
PATHOLOGIST: H. GILES                                                          

                                  NITROFURANTOIN


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      53    58    61    81    127   207   408   449   457   460                 |
 |      473   533   611   631   651   664   688   688   697   708                 |
 |      713   714                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.13%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      55    156   186   236   335   378   496   530   574   580                 |
 |      602   605   614   622   631   660   673   699   714   723                 |
 |      723                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      65    527   575   576   602   621   639   660   667   669                 |
 |      684   687   694   695   729   729                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                  NITROFURANTOIN


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |    92.0  90.0  88.0  88.0  86.0  78.0  76.0  76.0  68.0  56.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.13%      |    98.0  96.0  92.0  90.0  88.0  88.0  84.0  76.0  68.0  58.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.25%      |    98.0  98.0  98.0  98.0  98.0  98.0  96.0  90.0  84.0  68.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                UNTREATD         0.13%            0.25%         |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       56.0%            58.0%            68.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.173N         P=0.897N         P=0.197N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       460.5            513.9            613.7         |
 |NATURAL DEATHS (C)      |       (52.9)           (44.8)           (39.3)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       611.4            639.2            692.8         |
 |(STANDARD ERROR)        |       (29.9)           (24.0)           (14.5)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                  NITROFURANTOIN


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 31     CENSORED DEATHS 0    TERMINAL 19        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      148   444   452   456   475   500   521   524   534   561                 |
 |      589   593   601   603   607   607   631   635   649   654                 |
 |      667   686   687   696   708   714   714   717   722   728                 |
 |      728                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.13%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      469   575   596   609   617   670   687   694   696   706                 |
 |      708   709   709                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      568   625   630   639   649   656   660   678   696   708                 |
 |      729   729   729                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                  NITROFURANTOIN


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0  98.0  98.0  98.0  98.0  90.0  82.0  72.0  60.0  38.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.13%      |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  94.0  90.0  74.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.25%      |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0  86.0  74.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                UNTREATD         0.13%            0.25%         |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       38.0%            74.0%            74.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001          P<0.001          P<0.001       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       598.4            649.6            668.9         |
 |NATURAL DEATHS (C)      |       (22.0)           (20.2)           (13.5)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       648.4            709.1            714.1         |
 |(STANDARD ERROR)        |       (16.3)           ( 7.2)           ( 5.1)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                           NITROFURANTOIN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        0.13%            = 2
                                                        0.25%            = 3

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

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

      |
      |
  100 + 1        1 3
      |
      |          113             2                                                          3
      |                          2    2                                                     3      3
   95 +
      |           1  1                2      2
      |              1       1               2               2                                     3   3
      |
   90 +                      1           1                   2     2                                   3  3
      |
P     |                                  1                         2     1            2                   3  3
E     |                                                                  1      1     2     2                3   3
R  85 +
C     |                                                                         11          2     2              33
E     |                                                                                           22
N     |
T  80 +                                                                          1 1               2   2          3 3
      |
S     |                                                                            1         1         22           33
U     |                                                                                      1          21           33
R  75 +
V     |                                                                                                  12 1
I     |                                                                                                   2 1 1       3     3
V     |
A  70 +                                                                                                     2 1  1
L     |
      |                                                                                                          1 2 1      3
      |                                                                                                            2  2
   65 +
      |                                                                                                              11 2
      |                                                                                                               1 1 2
      |
   60 +
      |
      |                                                                                                                   2 2
      |                                                                                                                 1   1
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 11 obs hidden.

                                                           NITROFURANTOIN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        0.13%            = 2
                                                        0.25%            = 3

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

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

      |
      |
  100 + 1                       1                                                 2               3
      |                         1                                             1   2               32       3
      |                                                                       1 11                 2   22  3 3
      |                                                                          1 1                    2 2  33
   90 +                                                                            1   1                  2   33  2
      |                                                                                1   1                   3 32  2
P     |                                                                                    1 1                   3 3 22
E     |                                                                                      1   1                    223
R  80 +                                                                                          1    1                22   3
C     |
E     |                                                                                               111               2   2
N     |
T  70 +
      |                                                                                                 1   1
S     |                                                                                                     1 1
U     |                                                                                                       11
R  60 +                                                                                                        1  1
V     |                                                                                                           1 1
I     |                                                                                                             111
V     |                                                                                                               1 1
A  50 +
L     |
      |                                                                                                                 111
      |
   40 +
      |                                                                                                                   1 1
      |
      |
   30 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 12 obs hidden.

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