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TDMS Study 05004-03 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 09/03/94   
EXP: 05004                          FURAN                      TIME: 00:15:07   
TEST: 03              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 56202    
CONT: N01CP9565101                                             CAS: 110-00-9    
PATHOLOGIST: H. GILES                        S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
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REMOVAL DATE RANGE:                                                             


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TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Southern Research Inst                                    DATE: 09/03/94  
EXP: 05004                          FURAN                      TIME: 00:15:07  
TEST: 03              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 56202   
CONT: N01CP9565101                                             CAS: 110-00-9   
PATHOLOGIST: H. GILES                        S. EUSTIS                         

                                       FURAN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 6    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      464   549   611   629   645   659   660   666   680   689                 |
 |      716                                                                       |
 |  CENSORED DEATHS                                                               |
 |      53    115   188   319   407   613                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2. MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 5    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      384   421   470   525   539   587   602   629   660   660                 |
 |      660   660   668   680   687   694   702                                   |
 |  CENSORED DEATHS                                                               |
 |      25    29    54    60    85                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 4. MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 4    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      394   520   541   556   589   613   618   618   627   627                 |
 |      633   634   639   665   678   688   688   703   707   725                 |
 |  CENSORED DEATHS                                                               |
 |      46    70    254   410                                                     |
 |                                                                                |
 ==================================================================================

                                       FURAN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 8. MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 33     CENSORED DEATHS 1    TERMINAL 16        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      421   421   443   448   456   490   575   583   591   609                 |
 |      617   624   645   655   656   665   666   667   680   686                 |
 |      688   688   694   694   694   695   695   695   695   696                 |
 |      698   707   723                                                           |
 |  CENSORED DEATHS                                                               |
 |      52                                                                        |
 |                                                                                |
 ==================================================================================

                                       FURAN


                       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  97.8  97.8  95.6  84.2  75.1      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |2. MG/KG   |   100.0 100.0 100.0 100.0  95.6  93.3  88.9  84.4  73.3  62.2      |
 |           |                                                                    |
 |           |                                                                    |
 |4. MG/KG   |   100.0 100.0 100.0 100.0  97.9  97.9  93.5  89.2  69.6  56.5      |
 |           |                                                                    |
 |           |                                                                    |
 |8. MG/KG   |   100.0 100.0 100.0 100.0  95.9  89.8  87.8  81.6  67.3  32.7      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       75.1%        62.2%        56.5%        32.7%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.245      P=0.086      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       633.5        601.6        623.2        626.1    |
 |NATURAL DEATHS (C)      |       (21.5)       (24.1)       (17.3)       (16.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       654.4        617.9        643.9        647.5    |
 |(STANDARD ERROR)        |       (22.9)       (29.4)       (22.2)       (17.6)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                       FURAN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      470   528   537   556   605   605   655   659   665   666                 |
 |      684   687   688   688   695   714                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2. MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      364   436   478   541   561   575   575   602   617   639                 |
 |      642   659   665   667   688   689   697   703                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 4. MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      388   402   421   462   541   549   557   561   591   627                 |
 |      627   635   654   655   666   688   688   691   702   703                 |
 |      708   714                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                       FURAN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 8. MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 29     CENSORED DEATHS 2    TERMINAL 19        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      339   424   457   471   511   521   532   549   575   583                 |
 |      592   596   598   613   623   627   633   644   663   664                 |
 |      665   665   689   696   697   698   701   716   718                       |
 |  CENSORED DEATHS                                                               |
 |      143   238                                                                 |
 |                                                                                |
 ==================================================================================

                                       FURAN


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE 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  88.0  82.0  68.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |2. MG/KG   |   100.0 100.0 100.0  98.0  98.0  94.0  92.0  84.0  74.0  64.0      |
 |           |                                                                    |
 |           |                                                                    |
 |4. MG/KG   |   100.0 100.0 100.0 100.0  94.0  92.0  90.0  82.0  72.0  56.0      |
 |           |                                                                    |
 |           |                                                                    |
 |8. MG/KG   |   100.0 100.0 100.0  97.9  95.8  91.7  85.4  72.9  54.2  39.6      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       68.0%        64.0%        56.0%        39.6%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.002      P=0.732      P=0.263      P=0.006  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       631.4        599.9        601.4        602.1    |
 |NATURAL DEATHS (C)      |       (18.2)       (22.5)       (22.2)       (17.7)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       697.8        682.5        672.8        633.8    |
 |(STANDARD ERROR)        |       ( 8.6)       (11.9)       (13.2)       (18.6)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                               FURAN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        2. MG/KG         = 2
                                                        4. MG/KG         = 3
                                                        8. MG/KG         = 4

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

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

      |
      |
  100 + 1                                                            2 3   4      1
      |                                                              2 3   2      1        3   1
      |                                                                    2  4    2       3  31         1
      |                                                                       4  4 2       2  3 3     3  1 1
   90 +                                                                          4   4     2 2      2 3  3 1  1  1
      |                                                                              4             42  2 33
P     |                                                                                            44  2   2     11
E     |                                                                                             4 4 4 32     21 1
R  80 +                                                                                                 4 4         11
C     |                                                                                                   433        1   1
E     |                                                                                                    4334          1  1
N     |                                                                                                      344 22
T  70 +                                                                                                        4 32322
      |                                                                                                          443 22
S     |                                                                                                               22
U     |                                                                                                           4 43 2    2
R  60 +                                                                                                             44
V     |                                                                                                                3  3 3
I     |                                                                                                              44
V     |
A  50 +
L     |
      |
      |
   40 +
      |                                                                                                               44
      |                                                                                                                4  4
      |                                                                                                                   4 4
   30 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 16 obs hidden.

                                                               FURAN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        2. MG/KG         = 2
                                                        4. MG/KG         = 3
                                                        8. MG/KG         = 4

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

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

      |
      |
  100 + 1                                                     4  2    3            1
      |                                                       4  2    3 3  4 2     1        1
      |                                                                 3  3 2   3 42       112 1
      |                                                                          3 4    4     2 12      1
P  90 +                                                                                 4  4  33 2 2
E     |                                                                                    44  33       1      1
R     |                                                                                     4  433 2  32  2    1 1
C     |                                                                                        4   44 3   23 2   11
E  80 +                                                                                             4 4           1 1
N     |                                                                                               44   332   2  11
T     |                                                                                                     3  3 22
      |                                                                                                4 4     3  2  11
S  70 +                                                                                                  444      3  31 1
U     |                                                                                                    44        22 1   1
R     |                                                                                                     44       322    2
V     |                                                                                                      4   4
I  60 +                                                                                                                33
V     |
A     |                                                                                                          4   4  3   3
L     |                                                                                                              44
   50 +
      |
      |                                                                                                               44 4
      |
   40 +                                                                                                                  4  4
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 19 obs hidden.

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