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TDMS Study 05006-05 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 09/03/94   
EXP: 05006                      BENZALDEHYDE                   TIME: 09:00:54   
TEST: 05              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 56133    
CONT: NO1CP9565101                                             CAS: 000100527   
PATHOLOGIST: J. HEATH                        S. EUSTIS                          
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REASONS FOR REMOVAL:                                                            
                                                                                
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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Southern Research Inst                                    DATE: 09/03/94  
EXP: 05006                      BENZALDEHYDE                   TIME: 09:00:54  
TEST: 05              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 56133   
CONT: NO1CP9565101                                             CAS: 000100527  
PATHOLOGIST: J. HEATH                        S. EUSTIS                         

                                   BENZALDEHYDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      479   507   508   585   588   593   593   600   610   696                 |
 |      722   724   726                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 200.    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      235   495   561   564   617   632   652   668   668   676                 |
 |      682   692   697   708   710   711   714   714   719   722                 |
 |      728                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 400.    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 29     CENSORED DEATHS 0    TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      154   202   264   299   373   373   375   388   427   446                 |
 |      499   506   512   558   558   558   573   585   593   605                 |
 |      626   680   680   697   705   712   715   718   718                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                   BENZALDEHYDE


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


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0  98.0  94.0  84.0  82.0  74.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |200.       |   100.0 100.0  98.0  98.0  98.0  98.0  96.0  92.0  86.0  58.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |400.       |   100.0  98.0  94.0  92.0  84.0  80.0  74.0  60.0  58.0  42.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE          200.             400.          |
 |                                CONTROL          MG/KG            MG/KG         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       74.0%            58.0%            42.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001          P=0.176          P<0.001       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       610.1            646.0            520.7         |
 |NATURAL DEATHS (C)      |       (23.5)           (24.6)           (30.4)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       698.1            694.1            608.2         |
 |(STANDARD ERROR)        |       ( 9.5)           (11.7)           (22.9)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                   BENZALDEHYDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      364   463   520   534   578   579   602   620   674   674                 |
 |      681   695   698   701   711   715   719                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 200.    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      491   495   542   583   613   620   628   652   668   669                 |
 |      682   684   696   697   697   702   718                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 400.    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      138   151   159   231   250   275   485   520   521   554                 |
 |      561   570   613   629   652   659   676   692   695   698                 |
 |      711                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                   BENZALDEHYDE


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0  98.0  98.0  96.0  92.0  86.0  84.0  66.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |200.       |   100.0 100.0 100.0 100.0 100.0 100.0  94.0  92.0  84.0  66.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |400.       |   100.0  94.0  90.0  88.0  88.0  86.0  82.0  76.0  68.0  58.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE          200.             400.          |
 |                                CONTROL          MG/KG            MG/KG         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       66.0%            66.0%            58.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.302          P=1.000N         P=0.352       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       619.3            637.5            497.1         |
 |NATURAL DEATHS (C)      |       (24.7)           (17.4)           (44.6)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       692.4            698.5            632.2         |
 |(STANDARD ERROR)        |       (11.1)           ( 8.5)           (24.7)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                            BENZALDEHYDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        200.    MG/KG    = 2
                                                        400.    MG/KG    = 3

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

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

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

                                                                   WEEK

NOTE: 8 obs hidden.

                                                            BENZALDEHYDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        200.    MG/KG    = 2
                                                        400.    MG/KG    = 3

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

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

      |
      |
  100 + 1                     3                                  1                    2
      |
      |                       3 3                                1                1
      |                         33                                                1   2    1  2
   95 +
      |                          3          3                                              1 12     2
      |                                     3   3                                            1     12    2
      |
   90 +                                         3   3                                                    22
      |
P     |                                             3                                3             1   1  22
E     |                                                                              3     3           1  12   2
R  85 +
C     |                                                                                                   1    2  21
E     |                                                                                    3    3
N     |
T  80 +                                                                                         33                211
      |
S     |                                                                                          33                 1 1
U     |                                                                                           3      3          2 2
R  75 +
V     |                                                                                                  3 3          11
I     |                                                                                                    3   3       11
V     |
A  70 +                                                                                                        3 3    2211
L     |
      |                                                                                                          3 3   2 2
      |                                                                                                            3 3   1  1
   65 +
      |                                                                                                              33
      |
      |
   60 +                                                                                                               3 3
      |
      |                                                                                                                 3   3
      |
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 5 obs hidden.

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