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TDMS Study 05024-02 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Battelle Columbus                                         DATE: 09/04/94   
EXP: 05024                  N-METHYLOLACRYLAMIDE               TIME: 04:50:36   
TEST: 02              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 60333    
CONT: NO1CP9565302                                             CAS: 924-42-5    
PATHOLOGIST: J. TOFT                         S. EUSTIS                          
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REASONS FOR REMOVAL:                                                            
                                                                                
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REMOVAL DATE RANGE:                                                             


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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Battelle Columbus                                         DATE: 09/04/94  
EXP: 05024                  N-METHYLOLACRYLAMIDE               TIME: 04:50:36  
TEST: 02              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 60333   
CONT: NO1CP9565302                                             CAS: 924-42-5   
PATHOLOGIST: J. TOFT                         S. EUSTIS                         

                               N-METHYLOLACRYLAMIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      103   182   199   220   297   432   464   467   528   589                 |
 |      617   624   638   661   673   675   683   683   684   729                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 25 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 30     CENSORED DEATHS 0    TERMINAL 20        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      50    112   117   126   135   165   201   221   415   432                 |
 |      455   460   485   501   502   600   611   617   634   634                 |
 |      652   683   684   686   687   690   691   708   711   727                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 50 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 29     CENSORED DEATHS 0    TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      181   257   366   444   476   476   478   485   486   501                 |
 |      502   528   548   569   582   589   626   645   645   647                 |
 |      654   667   668   670   687   690   691   729   729                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                               N-METHYLOLACRYLAMIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   731 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0  98.0  92.0  90.0  90.0  84.0  82.0  80.0  72.0  60.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |25 MG/KG   |    98.0  88.0  84.0  84.0  82.0  74.0  70.0  68.0  58.0  40.0      |
 |           |                                                                    |
 |           |                                                                    |
 |50 MG/KG   |   100.0 100.0  96.0  96.0  94.0  84.0  76.0  68.0  58.0  42.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE          25 MG/KG         50 MG/KG      |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       60.0%            40.0%            42.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.125          P=0.070          P=0.128       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       507.4            479.7            559.2         |
 |NATURAL DEATHS (C)      |       (45.1)           (41.5)           (25.0)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       641.6            580.2            631.3         |
 |(STANDARD ERROR)        |       (23.7)           (30.4)           (18.8)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                               N-METHYLOLACRYLAMIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 8      CENSORED DEATHS 1    TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      563   655   675   684   690   690   716   724                             |
 |  CENSORED DEATHS                                                               |
 |      401                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 25 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      347   421   548   592   592   616   669   675   681   688                 |
 |      690   694   705   710   718                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 50 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 1    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      527   528   553   580   589   647   653   655   667   667                 |
 |      672   674   711   723   729   729                                         |
 |  CENSORED DEATHS                                                               |
 |      653                                                                       |
 |                                                                                |
 ==================================================================================

                               N-METHYLOLACRYLAMIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   731 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0  95.9  83.7      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |25 MG/KG   |   100.0 100.0 100.0  98.0  96.0  96.0  96.0  90.0  88.0  70.0      |
 |           |                                                                    |
 |           |                                                                    |
 |50 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  90.0  84.0  67.6      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE          25 MG/KG         50 MG/KG      |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       83.7%            70.0%            67.6%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.074          P=0.142          P=0.081       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       674.6            623.1            644.0         |
 |NATURAL DEATHS (C)      |       (17.7)           (28.4)           (17.2)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       715.4            698.6            701.6         |
 |(STANDARD ERROR)        |       ( 7.6)           (10.9)           ( 7.9)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                        N-METHYLOLACRYLAMIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        25 MG/KG         = 2
                                                        50 MG/KG         = 3

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

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

      |
      |
  100 + 1        2       1           3
      |          2       12          1           3
      |                   222        1  1  1     3                3           3
      |                     2 2            1           1                      3    3
P  90 +                       2   2                    1                    1
E     |                           2     2                                   1     133
R     |                                 2  2                              2       1 33      1
C     |                                                                   2 2        3 3    1         1
E  80 +                                                                     2   2                     1   1
N     |                                                                         22     3    3             11
T     |                                                                          2   2 2    3  3  3        1 1   1
      |                                                                                           3 3            1 1
S  70 +                                                                                2            3 32
U     |                                                                                               32 2 3       11
R     |                                                                                                  2232 3
V     |                                                                                                             1       1
I  60 +                                                                                                     2 32            1
V     |                                                                                                        2  3 2
A     |
L     |                                                                                                           3 22
   50 +
      |
      |                                                                                                              2  2   3
      |                                                                                                                 2 2 3
   40 +                                                                                                                   2 2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 15 obs hidden.

                                                        N-METHYLOLACRYLAMIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        25 MG/KG         = 2
                                                        50 MG/KG         = 3

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

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

      |
      |
  100 + 1                                                      2                            3    1
      |
      |                                                        2           2                     1             1
      |                                                                    2                3  2               1   1
   95 +
      |                                                                                        2   3  2            11
P     |                                                                                            3  3
E     |                                                                                                             11
R  90 +                                                                                               2  2    3
C     |
E     |                                                                                                  2    33  2  1   1
N     |                                                                                                           22     11
T  85 +
      |                                                                                                        3  322     1 1
S     |                                                                                                             22
U     |
R  80 +
V     |
I     |                                                                                                           33 22
V     |                                                                                                            3  223
A  75 +
L     |                                                                                                                22 3
      |                                                                                                                 22
      |                                                                                                                   3 3
   70 +                                                                                                                  2  2
      |
      |                                                                                                                     3
      |
   65 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 6 obs hidden.

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