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TDMS Study 05212-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                          OXAZEPAM                                       DATE: 07/19/96       
EXPERIMENT: 05212 TEST: 05                                                                                     TIME: 17:01:29       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-15322                              ROUTE: DOSED FEED                                              NTP C#: 62453B       
PATHOLOGIST: RYAN, M.                                                                                          CAS: 604-75-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             CORE STUDY                                                             
                                                                                                                                    

               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 PPM                                                                         
                                       INCLUDE 002    0 PPM                                                                         
                                       INCLUDE 003    625 PPM                                                                       
                                       INCLUDE 004    625 PPM                                                                       
                                       INCLUDE 007    2500 PPM                                                                      
                                       INCLUDE 008    2500 PPM                                                                      
                                       INCLUDE 009    5000 PPM                                                                      
                                       INCLUDE 010    5000 PPM                                                                      
                                       INCLUDE 011    10,000  PPM STOP                                                              
                                       INCLUDE 012    10,000  PPM STOP                                                              
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Columbus                                          OXAZEPAM                                       DATE: 07/19/96      
EXPERIMENT: 05212 TEST: 05                                                                                     TIME: 17:01:29      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-15322                              ROUTE: DOSED FEED                                              NTP C#: 62453B      
PATHOLOGIST: RYAN, M.                                                                                          CAS: 604-75-1       
                                     OXAZEPAM

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 33     CENSORED DEATHS 0    TERMINAL 17        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      471   480   491   498   517   519   537   541   554   571                 |
 |      585   592   601   608   621   681   682   682   682   684                 |
 |      688   690   690   694   695   695   696   698   698   698                 |
 |      711   716   723                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 625 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 39     CENSORED DEATHS 0    TERMINAL 11        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      386   426   448   452   466   473   481   501   523   524                 |
 |      536   536   550   557   571   572   578   585   585   586                 |
 |      586   589   604   614   620   625   628   634   642   651                 |
 |      652   667   682   698   702   709   712   714   722                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2500 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 44     CENSORED DEATHS 0    TERMINAL 6         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      381   400   415   424   440   479   507   526   554   558                 |
 |      568   570   571   576   596   599   600   605   613   613                 |
 |      620   626   633   641   641   653   655   659   659   662                 |
 |      663   663   673   676   680   681   684   687   689   695                 |
 |      701   702   705   716                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                     OXAZEPAM

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 5000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 50     CENSORED DEATHS 0    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      223   224   237   422   432   439   439   442   451   451                 |
 |      452   467   498   498   507   512   516   519   521   526                 |
 |      528   529   529   529   530   530   541   541   543   550                 |
 |      562   562   562   575   576   577   585   605   605   610                 |
 |      618   620   628   631   634   647   688   705   710   712                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 10,000  PPM STOP                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 50     CENSORED DEATHS 0    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      317   480   484   490   498   542   558   564   567   572                 |
 |      584   585   587   590   590   596   596   605   613   613                 |
 |      613   614   614   616   618   620   627   631   634   638                 |
 |      641   641   641   645   647   653   659   670   681   687                 |
 |      690   691   692   694   696   697   702   719   719   722                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                     OXAZEPAM

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

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0 100.0 100.0  96.0  84.0  74.0  70.0  34.0      |
 |           |                                                                    |
 |           |                                                                    |
 |625 PPM    |   100.0 100.0 100.0 100.0  98.0  86.0  76.0  54.0  38.0  22.0      |
 |           |                                                                    |
 |           |                                                                    |
 |2500 PPM   |   100.0 100.0 100.0 100.0  92.0  88.0  84.0  64.0  36.0  12.0      |
 |           |                                                                    |
 |           |                                                                    |
 |5000 PPM   |   100.0 100.0  94.0  94.0  92.0  76.0  42.0  22.0   8.0   0.0      |
 |           |                                                                    |
 |           |                                                                    |
 |10,000     |   100.0 100.0 100.0  98.0  98.0  94.0  88.0  64.0  26.0   0.0      |
 |PPM STOP   |                                                                    |
 |           |                                                                    |
 ==================================================================================
                                     OXAZEPAM

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

 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                           DOSE                                              |
 |                                                                                                                             |
 |                                0 PPM              625 PPM            2500 PPM           5000 PPM           10,000           |
 |                                                                                                            PPM STOP         |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       34.0%              22.0%              12.0%               0.0%               0.0%            |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P<0.001            P=0.070            P=0.002            P<0.001            P<0.001          |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       626.9              584.3              605.9              530.8              616.9            |
 |NATURAL DEATHS (C)      |       (14.4)             (14.0)             (13.5)             (15.1)             (10.5)           |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       662.0              616.3              620.8              530.8              616.9            |
 |(STANDARD ERROR)        |       (11.7)             (13.9)             (13.2)             (15.1)             (10.5)           |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    

       (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)
                                     OXAZEPAM

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 1    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      223   228   522   529   550   569   571   583   613   641                 |
 |      647   690   696   697   700   701   708                                   |
 |  CENSORED DEATHS                                                               |
 |      597                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 625 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      288   400   475   478   550   590   606   612   631   633                 |
 |      634   647   654   666   669   697   708   715   717   718                 |
 |      718   718   718   728                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2500 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 30     CENSORED DEATHS 0    TERMINAL 20        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      414   432   453   506   539   540   550   556   565   578                 |
 |      583   585   589   597   597   611   632   633   634   646                 |
 |      652   669   692   697   700   700   701   703   703   728                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                     OXAZEPAM

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 5000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      17    413   550   613   624   631   634   638   641   646                 |
 |      669   675   679   683   700   711   715   715   721                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 10,000  PPM STOP                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 25     CENSORED DEATHS 0    TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      478   506   562   562   562   570   585   599   604   609                 |
 |      609   646   662   669   669   697   699   703   714   715                 |
 |      716   718   719   725   725                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                     OXAZEPAM

                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0  96.0  96.0  96.0  96.0  92.0  84.0  77.9  65.6      |
 |           |                                                                    |
 |           |                                                                    |
 |625 PPM    |   100.0 100.0 100.0  98.0  96.0  92.0  92.0  88.0  74.0  52.0      |
 |           |                                                                    |
 |           |                                                                    |
 |2500 PPM   |   100.0 100.0 100.0 100.0  98.0  94.0  88.0  70.0  58.0  40.0      |
 |           |                                                                    |
 |           |                                                                    |
 |5000 PPM   |    98.0  98.0  98.0  98.0  96.0  96.0  96.0  94.0  80.0  62.0      |
 |           |                                                                    |
 |           |                                                                    |
 |10,000     |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  82.0  74.0  50.0      |
 |PPM STOP   |                                                                    |
 |           |                                                                    |
 ==================================================================================
                                     OXAZEPAM

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

 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                           DOSE                                              |
 |                                                                                                                             |
 |                                0 PPM              625 PPM            2500 PPM           5000 PPM           10,000           |
 |                                                                                                            PPM STOP         |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       65.6%              52.0%              40.0%              62.0%              50.0%            |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.767            P=0.339            P=0.019            P=0.967            P=0.257          |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       580.5              623.8              606.2              614.5              640.9            |
 |NATURAL DEATHS (C)      |       (36.0)             (23.1)             (15.3)             (37.0)             (14.8)           |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       675.9              678.5              655.3              685.5              685.0            |
 |(STANDARD ERROR)        |       (15.7)             (13.3)             (12.6)             (15.9)             ( 9.7)           |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    

       (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)
                                                              OXAZEPAM
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        625 PPM          = 2
                                                        2500 PPM         = 3
                                                        5000 PPM         = 4
                                                        10,000  PPM STOP = 5

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

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

      |
      |
  112 +
      |
      |
      | 1                                  4               5         32 3  2       11
   96 +                                    4 4                          3 32  2 2   1511
      |                                                                    343  2 2235 1 1 1  5
P     |                                                                      44    22  23  1311 55
E     |                                                                       4 4      2   23 1 151
R  80 +                                                                         4 4        2 2  3 1 1 1
C     |                                                                           4    4     2 22 335 111
E     |                                                                                444      2 23  531 1         1
N     |                                                                                  4 4      222  33
T  64 +                                                                                    44           33
      |                                                                                             2 2  333        11
S     |                                                                                               2 22 333       11
U     |                                                                                                  222 3 3
R  48 +                                                                                     4 4           522  3 3
V     |                                                                                       44            222
I     |                                                                                        4 4            22  2   1 11
V     |                                                                                          4 4         55  3232 2  11 1
A  32 +                                                                                                       55   33 222
L     |                                                                                            44   4      5 55 33
      |                                                                                                 44        5 533 2 2 2
      |                                                                                                  44           33
   16 +                                                                                                   444        553 3
      |                                                                                                     4 4          3  3
      |                                                                                                       4      454 5
      |                                                                                                                4455
    0 +                                                                                                                 4 5
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 74 obs hidden.
                                                              OXAZEPAM
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        625 PPM          = 2
                                                        2500 PPM         = 3
                                                        5000 PPM         = 4
                                                        10,000  PPM STOP = 5

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

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

      |
      |
  100 + 1  4                               1          2                   3         5
      |    4                               11         2                 243 3       5   5
      |                                     1                           24  3   3  22   3  11  4 5       4
      |                                                                             2   3   13 1         4 4
P  90 +                                                                                      331 51   2    44
E     |                                                                                       33  5 5 2 2
R     |                                                                                        3331 1  521  24
C     |                                                                                          3 3     1   14
E  80 +                                                                                            33        11   4
N     |                                                                                                 5   2 1   44 1
T     |                                                                                             3 33      22 524411
      |                                                                                                             4 4
S  70 +                                                                                                3 3        2   114
U     |                                                                                                  3  3         2114
R     |                                                                                                               5512  1
V     |                                                                                                     3 3         54  4
I  60 +                                                                                                       33
V     |                                                                                                        3  3
A     |                                                                                                           3  33  22
L     |                                                                                                                   2 2
   50 +                                                                                                                   5 5
      |                                                                                                               33
      |
      |                                                                                                                3  3
   40 +                                                                                                                   3 3
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 42 obs hidden.