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TR 399 Rat Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Mason                                                     DATE: 09/06/94   
EXP: 05047                  TITANOCENE DICHLORIDE              TIME: 22:05:36   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 04502    
CONT: N01ES9561904                                             CAS: 1271-19-8   
PATHOLOGIST: K. MURTHY                       S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Mason                                                     DATE: 09/06/94  
EXP: 05047                  TITANOCENE DICHLORIDE              TIME: 22:05:36  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 04502   
CONT: N01ES9561904                                             CAS: 1271-19-8  
PATHOLOGIST: K. MURTHY                       S. EUSTIS                         

                               TITANOCENE DICHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 738 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = VEHICLE 79                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 19     CENSORED DEATHS 10   TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      474   499   520   550   577   578   579   605   639   647                 |
 |      647   659   670   681   690   716   717   722   727                       |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   458   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.025 G/KG 79                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 29     CENSORED DEATHS 11   TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      54    253   306   370   400   474   484   509   526   536                 |
 |      537   553   567   582   583   603   611   628   634   635                 |
 |      650   653   659   667   697   701   717   718   732                       |
 |  CENSORED DEATHS                                                               |
 |      406   457   457   457   457   458   458   458   458   458                 |
 |      458                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.05 G/KG 79                                   |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 34     CENSORED DEATHS 12   TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      68    229   248   251   254   261   264   264   318   338                 |
 |      383   401   465   467   514   515   540   586   612   612                 |
 |      612   617   618   620   647   662   675   690   690   708                 |
 |      709   711   722   734                                                     |
 |  CENSORED DEATHS                                                               |
 |      405   457   457   457   457   457   458   458   458   458                 |
 |      458   639                                                                 |
 |                                                                                |
 ==================================================================================

                               TITANOCENE DICHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 738 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   738 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE 79 |   100.0 100.0 100.0 100.0 100.0  98.3  95.0  86.7  80.0  68.3      |
 |           |                                                                    |
 |           |                                                                    |
 |0.025      |    98.6  98.6  97.1  95.7  92.9  89.4  82.5  73.9  61.9  51.6      |
 |G/KG 79    |                                                                    |
 |           |                                                                    |
 |0.05       |    98.6  98.6  88.6  85.7  82.9  79.3  74.0  72.3  58.1  43.6      |
 |G/KG 79    |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE 79       0.025            0.05          |
 |                                                 G/KG 79          G/KG 79       |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       68.3%            51.6%            43.6%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.002          P=0.046          P=0.002       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       626.2            553.1            500.1         |
 |NATURAL DEATHS (C)      |       (18.0)           (28.7)           (32.4)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       667.6            616.6            576.2         |
 |(STANDARD ERROR)        |       (12.8)           (17.8)           (21.2)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                               TITANOCENE DICHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 743 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = VEHICLE 79                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 23     CENSORED DEATHS 10   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      304   342   384   413   549   598   611   615   622   624                 |
 |      624   639   651   652   688   693   694   695   700   702                 |
 |      707   709   715                                                           |
 |  CENSORED DEATHS                                                               |
 |      463   463   463   463   463   464   464   464   464   464                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.025 G/KG 79                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 71     UNCENSORED DEATHS 30     CENSORED DEATHS 11   TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      177   350   430   451   464   504   510   570   574   590                 |
 |      595   608   610   631   639   639   643   645   645   645                 |
 |      660   661   688   688   692   694   707   715   721   721                 |
 |  CENSORED DEATHS                                                               |
 |      463   463   463   463   463   463   463   464   464   464                 |
 |      549                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.05 G/KG 79                                   |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 29     CENSORED DEATHS 10   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      232   234   247   307   338   344   345   415   457   457                 |
 |      471   485   493   493   496   521   575   617   639   643                 |
 |      653   665   665   673   674   683   693   694   742                       |
 |  CENSORED DEATHS                                                               |
 |      463   463   463   464   464   464   464   464   464   464                 |
 |                                                                                |
 ==================================================================================

                               TITANOCENE DICHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 743 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   743 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE 79 |   100.0 100.0 100.0  97.1  94.3  94.3  94.3  90.9  77.4  62.3      |
 |           |                                                                    |
 |           |                                                                    |
 |0.025      |   100.0  98.6  98.6  97.2  97.2  92.8  89.5  82.7  64.2  50.6      |
 |G/KG 79    |                                                                    |
 |           |                                                                    |
 |0.05       |   100.0 100.0  95.7  90.0  88.6  82.3  75.4  73.7  63.4  53.1      |
 |G/KG 79    |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE 79       0.025            0.05          |
 |                                                 G/KG 79          G/KG 79       |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       62.3%            50.6%            53.1%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.167          P=0.227          P=0.197       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       605.7            595.6            515.6         |
 |NATURAL DEATHS (C)      |       (25.8)           (22.4)           (29.1)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       658.0            638.6            608.9         |
 |(STANDARD ERROR)        |       (14.7)           (15.1)           (18.8)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)

                                                       TITANOCENE DICHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE 79       = 1
                                                        0.025 G/KG 79    = 2
                                                        0.05 G/KG 79     = 3

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

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

      |
      |
  100 + 1        2 3                                                               1
      |          2 3                        3   32      2                          1   1   1
      |                                         33      2         2     2                  1   1
      |                                          33                     2          2           1   1
P  90 +                                                                            2 2  2
E     |                                           3        3  3                         2   2      1    1    1
R     |                                                       3      3  3                   22               11
C     |                                                                 3         3          2 2              1  1
E  80 +                                                                           3      3     2 2  2            11
N     |                                                                                                           1 11
T     |                                                                                  3    3     2   22           1   1
      |                                                                                             3    2 2             11
S  70 +                                                                                                    22
U     |                                                                                                  33 2 2           1  1
R     |                                                                                                       22
V     |                                                                                                   3   32 22
I  60 +                                                                                                       3  32   2
V     |                                                                                                          3 3 322 2
A     |
L     |                                                                                                              3  32  22
   50 +
      |                                                                                                                 3 3
      |                                                                                                                   3 3
      |                                                                                                                     33
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 20 obs hidden.

                                                       TITANOCENE DICHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE 79       = 1
                                                        0.025 G/KG 79    = 2
                                                        0.05 G/KG 79     = 3

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

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

      |
      |
  100 + 1                            2       3          1
      |                              2                  1     12
      |                                      3  3             12     1      2
      |                                         3       3            1   1  2   2
   95 +
      |                                                 3     3          1      2 2            1
      |                                                       33                  2    2       1       1
      |                                                                                22              1 1
   90 +                                                        3          3             2         2
      |                                                                   3      3
      |                                                                                                  11
      |                                                                          3 3              2   2   11
P  85 +
E     |                                                                            3 3
R     |                                                                              33               2 2  1 1
C     |                                                                                                 22   11
E  80 +
N     |                                                                                                  2  2 11
T     |                                                                               3    3                22 1     1
      |
S  75 +                                                                                    3       3
U     |                                                                                            3      3          11
R     |                                                                                                   3  22
V     |
I  70 +
V     |                                                                                                      3 3      11
A     |                                                                                                       2  2
L     |                                                                                                        3 3     11
   65 +
      |                                                                                                          2 3 2  11
      |                                                                                                                  1    1
      |
   60 +                                                                                                            33
      |                                                                                                             322
      |                                                                                                               22
      |                                                                                                              332 2
   55 +                                                                                                               3      3
      |                                                                                                                      33
      |
      |                                                                                                                  2    2
   50 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 5 obs hidden.

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