National Toxicology Program

National Toxicology Program
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TR 341 Rat Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 09/07/94   
EXP: 05051                     NITROFURANTOIN                  TIME: 07:15:02   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: C55196   
CONT: NOIES28024                                               CAS: 67-20-9     
PATHOLOGIST: R. THOMPSON                                                        
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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Southern Research Inst                                    DATE: 09/07/94  
EXP: 05051                     NITROFURANTOIN                  TIME: 07:15:02  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: C55196  
CONT: NOIES28024                                               CAS: 67-20-9    
PATHOLOGIST: R. THOMPSON                                                       

                                  NITROFURANTOIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 26     CENSORED DEATHS 0    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      387   455   506   533   554   559   579   591   591   601                 |
 |      621   621   630   633   643   645   653   659   677   678                 |
 |      695   715   723   729   729   729                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.13%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      320   483   489   548   561   601   602   630   644   656                 |
 |      671   679   687   699   700   708   712   720   722   726                 |
 |      727   728   728                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      386   387   413   493   532   559   619   632   633   635                 |
 |      636   639   646   670   670   697   699   705   709   715                 |
 |      716   719   728   728                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                  NITROFURANTOIN


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       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   |   100.0 100.0 100.0 100.0  98.0  96.0  92.0  80.0  64.0  48.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.13%      |   100.0 100.0 100.0  98.0  98.0  96.0  94.0  86.0  80.0  54.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.25%      |   100.0 100.0 100.0 100.0  94.0  94.0  90.0  88.0  74.0  52.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                UNTREATD         0.13%            0.25%         |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       48.0%            54.0%            52.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.668N         P=0.512N         P=0.732N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       620.6            640.9            623.6         |
 |NATURAL DEATHS (C)      |       (16.9)           (21.5)           (21.9)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       673.1            689.0            678.9         |
 |(STANDARD ERROR)        |       (11.7)           (11.6)           (12.9)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                  NITROFURANTOIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 25     CENSORED DEATHS 0    TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      428   481   510   568   602   620   633   649   658   661                 |
 |      666   671   673   691   700   701   702   709   719   720                 |
 |      727   727   728   729   729                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.06%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      390   423   435   456   491   498   554   564   567   601                 |
 |      621   633   653   665   665   670   687   714   715   720                 |
 |      726   727   728   728                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.13%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      394   412   448   448   491   513   554   598   624   646                 |
 |      675   677   678   686   693   699   700   700   705                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                  NITROFURANTOIN


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       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   |   100.0 100.0 100.0 100.0 100.0  96.0  94.0  90.0  80.0  50.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.06%      |   100.0 100.0 100.0 100.0  96.0  92.0  88.0  80.0  70.0  52.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.13%      |   100.0 100.0 100.0 100.0  96.0  92.0  88.0  84.0  80.0  62.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                UNTREATD         0.06%            0.13%         |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       50.0%            52.0%            62.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.446N         P=1.000          P=0.489N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       656.1            609.6            596.9         |
 |NATURAL DEATHS (C)      |       (16.4)           (22.5)           (25.5)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       693.0            672.2            679.4         |
 |(STANDARD ERROR)        |       ( 9.7)           (13.7)           (13.3)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

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

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

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

      |
      |
  100 + 1                                                  2          1
      |                                                    2          1         1   2
      |                                                               3  3      1   223 1    1 2
      |                                                                               3     31 212
P  90 +                                                                                     3   32     2
E     |                                                                                         1  1      3
R     |                                                                                            1  12  3232
C     |                                                                                               11     2 2
E  80 +                                                                                                1  1    2  2
N     |                                                                                                     33    22
T     |                                                                                                   11133   32 22
      |                                                                                                     11
S  70 +                                                                                                      11   3   2 2
U     |                                                                                                       11
R     |                                                                                                        1 1 1  33222
V     |                                                                                                                 33
I  60 +                                                                                                            1  1
V     |                                                                                                               1  1
A     |                                                                                                                  11 1
L     |                                                                                                                   3 3
   50 +
      |                                                                                                                     1
      |
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 21 obs hidden.

                                                           NITROFURANTOIN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        0.06%            = 2
                                                        0.13%            = 3

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

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

      |
      |
  100 + 1                                                             23    1
      |
      |                                                               23 3 21       1
      |                                                                  3 2 23     1   1
   95 +
      |                                                                      2   2      1         1
      |                                                                       3  2    2           1    1
      |
   90 +                                                                               22 3             1  1
      |
      |                                                                                2 3      2         1 1
      |                                                                                         22     3    1 1
P  85 +
E     |                                                                                                3   3  11
R     |                                                                                          2     2   3  31 1
C     |
E  80 +                                                                                                2  2   3  113
N     |
T     |                                                                                                   2 2
      |                                                                                                     2  2  11
S  75 +
U     |                                                                                                        2 2 131
R     |                                                                                                             311
V     |
I  70 +                                                                                                          22  311
V     |
A     |                                                                                                           2  2
L     |                                                                                                              2 11
   65 +
      |                                                                                                               3311
      |                                                                                                                3    3
      |
   60 +                                                                                                                  11
      |
      |
      |
   55 +
      |                                                                                                                   1 1
      |                                                                                                                   2 2
      |
   50 +                                                                                                                     1
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 14 obs hidden.

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