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TDMS Study 05024-01 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Battelle Columbus                                         DATE: 09/04/94   
EXP: 05024                  N-METHYLOLACRYLAMIDE               TIME: 03:30:58   
TEST: 01              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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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Battelle Columbus                                         DATE: 09/04/94  
EXP: 05024                  N-METHYLOLACRYLAMIDE               TIME: 03:30:58  
TEST: 01              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 RATS
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      410   422   515   531   554   589   593   624   627   637                 |
 |      655   667   674   676   688   690   695   708   711   719                 |
 |      719   725                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 6 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 28     CENSORED DEATHS 0    TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      379   408   421   492   509   515   515   549   555   561                 |
 |      575   596   596   600   600   608   641   641   676   677                 |
 |      684   690   695   697   708   722   726   726                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 12 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      367   425   487   548   555   573   604   627   654   654                 |
 |      655   690   695   695   708   708   708   712   712   719                 |
 |      722   726   726                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                               N-METHYLOLACRYLAMIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       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  96.0  96.0  92.0  86.0  78.0  56.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |6 MG/KG    |   100.0 100.0 100.0 100.0  94.0  94.0  86.0  70.0  64.0  44.0      |
 |           |                                                                    |
 |           |                                                                    |
 |12 MG/KG   |   100.0 100.0 100.0 100.0  96.0  96.0  94.0  86.0  78.0  54.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE          6 MG/KG          12 MG/KG      |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       56.0%            44.0%            54.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=1.000          P=0.226          P=1.000       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       628.6            598.6            637.8         |
 |NATURAL DEATHS (C)      |       (19.6)           (18.8)           (21.2)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       685.9            656.9            688.1         |
 |(STANDARD ERROR)        |       (11.2)           (14.0)           (11.7)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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 RATS
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      351   381   529   578   613   639   656   676   676   698                 |
 |      702   702   702   718   725                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 6 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 28     CENSORED DEATHS 0    TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      119   296   423   443   443   458   508   532   535   549                 |
 |      550   575   575   590   612   626   641   644   656   667                 |
 |      668   668   684   688   698   711   715   726                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 12 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      383   443   555   578   578   595   617   625   652   652                 |
 |      668   688   711   712   715   715   726                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                               N-METHYLOLACRYLAMIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       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  98.0  96.0  96.0  94.0  92.0  86.0  70.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |6 MG/KG    |   100.0  98.0  98.0  96.0  94.0  88.0  82.0  72.0  62.0  44.0      |
 |           |                                                                    |
 |           |                                                                    |
 |12 MG/KG   |   100.0 100.0 100.0 100.0  98.0  96.0  96.0  88.0  80.0  66.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE          6 MG/KG          12 MG/KG      |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       70.0%            44.0%            66.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.747          P=0.007          P=0.788       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       623.1            571.4            624.3         |
 |NATURAL DEATHS (C)      |       (30.4)           (26.0)           (23.5)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       698.6            641.6            694.7         |
 |(STANDARD ERROR)        |       (11.4)           (18.4)           (10.7)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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
                                                        6 MG/KG          = 2
                                                        12 MG/KG         = 3

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

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

      |
      |
  100 + 1                                                         3  2   1
      |                                                           3  2   1 1
      |                                                                  2 1         32  1  1  3
      |                                                                               2 2   1  31
P  90 +                                                                                 22      1 3   1
E     |                                                                                           3     3
R     |                                                                                  2     22     1 3  1   3
C     |                                                                                         22         11
E  80 +                                                                                          2 2        1  1
N     |                                                                                            2   2       1  1  3
T     |                                                                                                           11 33
      |                                                                                                            1 13 3
S  70 +                                                                                                22
U     |                                                                                                 2    2       11
R     |                                                                                                      2     2  1 1
V     |                                                                                                                 11
I  60 +                                                                                                            22    33
V     |                                                                                                             22   11
A     |                                                                                                              22   1 1
L     |                                                                                                               2 2
   50 +                                                                                                                 2 2
      |
      |                                                                                                                   2 2
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 19 obs hidden.

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

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

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

      |
      |
  104 +
      |
      | 1                  2                                    1    3
      |                    2                           2        1    1        3
   96 +                                                2             1     2  3             1   3
      |                                                                    2  2             1   3  1
      |                                                                                            1     1
      |                                                                       2  2                 3  3  1   1
P  88 +                                                                          2      2             3   3  1 1
E     |                                                                                 2   2             33   1   1
R     |                                                                                     22             3   3
C     |                                                                                      2 2                   1  1
E  80 +                                                                                                        3  3   11
N     |                                                                                        2   2              3  3
T     |                                                                                                              3  3
      |                                                                                            2  2                1 1
S  72 +                                                                                               2  2              311
U     |                                                                                                  2 2              1 1
R     |                                                                                                    2 2           33
V     |                                                                                                                   3 3
I  64 +                                                                                                      2 2
V     |                                                                                                        2  2
A     |
L     |
   56 +                                                                                                           2 2
      |                                                                                                             22
      |                                                                                                              22
      |                                                                                                               2 2
   48 +                                                                                                                 22
      |                                                                                                                  22
      |                                                                                                                   2 2
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 5 obs hidden.

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