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TDMS Study 05079-02 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: LITRI                                                     DATE: 09/10/94   
EXP: 05079                          TALC                       TIME: 17:34:02   
TEST: 02              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: RESPIRATORY EXPOSURE WHOLE  NTP C#: 06008    
CONT:                                                          CAS: 14807966    
PATHOLOGIST: B. JONES                        F. HAHN                            
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: LITRI                                                     DATE: 09/10/94  
EXP: 05079                          TALC                       TIME: 17:34:02  
TEST: 02              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: RESPIRATORY EXPOSURE WHOLE  NTP C#: 06008   
CONT:                                                          CAS: 14807966   
PATHOLOGIST: B. JONES                        F. HAHN                           

                                       TALC


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 49     UNCENSORED DEATHS 17     CENSORED DEATHS 2    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      8     423   432   437   484   486   518   543   571   579                 |
 |      585   587   587   629   677   684   710                                   |
 |  CENSORED DEATHS                                                               |
 |      20    691                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = CONTROL LUNG TOX                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 39     UNCENSORED DEATHS 4      CENSORED DEATHS 24   TERMINAL 11        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      39    295   619   715                                                     |
 |  CENSORED DEATHS                                                               |
 |      185   185   185   185   186   186   187   187   368   368                 |
 |      369   369   369   369   369   369   549   549   549   549                 |
 |      549   549   550   550                                                     |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 6 MG/M3                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 49     UNCENSORED DEATHS 20     CENSORED DEATHS 1    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      253   253   320   344   423   546   550   558   584   590                 |
 |      591   624   626   633   681   685   688   710   719   722                 |
 |  CENSORED DEATHS                                                               |
 |      62                                                                        |
 |                                                                                |
 ==================================================================================

                                       TALC


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 6 MG/M3 LUNG TOX                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 40     UNCENSORED DEATHS 6      CENSORED DEATHS 25   TERMINAL 9         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      376   554   617   672   676   718                                         |
 |  CENSORED DEATHS                                                               |
 |      176   185   185   185   185   186   186   187   187   368                 |
 |      368   369   369   369   369   369   369   549   549   549                 |
 |      549   549   549   550   550                                               |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 18 MG/M3                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 1    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      28    114   115   159   422   438   457   478   538   541                 |
 |      554   658   672   721   724   725   727                                   |
 |  CENSORED DEATHS                                                               |
 |      622                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 18 MG/M3LUNG TOX                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 40     UNCENSORED DEATHS 8      CENSORED DEATHS 25   TERMINAL 7         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      113   114   114   215   550   569   594   646                             |
 |  CENSORED DEATHS                                                               |
 |      148   185   185   186   186   186   186   187   187   368                 |
 |      368   369   369   369   369   369   369   549   549   549                 |
 |      549   549   549   550   550                                               |
 |                                                                                |
 ==================================================================================

                                       TALC


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 736 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   736 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |    98.0  98.0  98.0  98.0  95.9  89.6  83.4  72.9  70.9  64.5      |
 |           |                                                                    |
 |           |                                                                    |
 |CONTROL    |    97.4  97.4  97.4  94.2  94.2  94.2  94.2  94.2  86.9  79.7      |
 |LUNG TOX   |                                                                    |
 |           |                                                                    |
 |6 MG/M3    |   100.0 100.0  95.8  91.7  89.6  89.6  89.6  77.1  70.8  58.3      |
 |           |                                                                    |
 |           |                                                                    |
 |6          |   100.0 100.0 100.0 100.0  95.7  95.7  95.7  88.8  82.0  61.5      |
 |MG/M3 LUNG |OX                                                                  |
 |           |                                                                    |
 |18 MG/M3   |    98.0  92.0  92.0  92.0  90.0  84.0  80.0  78.0  75.9  65.7      |
 |           |                                                                    |
 |           |                                                                    |
 |18         |   100.0  92.5  89.2  89.2  89.2  89.2  89.2  65.9  57.6  57.6      |
 |MG/M3LUNG T|X                                                                   |
 |           |                                                                    |
 ==================================================================================

                                       TALC


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 736 DAYS


 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                          DOSE                                               |
 |                                                                                                                             |
 |                                CONTROL         CONTROL         6 MG/M3         6               18 MG/M3        18           |
 |                                                LUNG TOX                        MG/M3 LUNG TOX                  MG/M3LUNG TOX|
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       64.5%           79.7%           58.3%           61.5%           65.7%           57.6%        |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.636          -----          P=0.771         P=0.953N        P=1.000N        P=0.752      |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       525.9           417.0           555.0           602.2           474.8           364.4        |
 |NATURAL DEATHS (C)      |       (38.7)          ( 155)          (34.3)          (50.8)          (57.5)          (86.5)       |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       647.6           476.8           648.4           481.1           644.9           426.2        |
 |(STANDARD ERROR)        |       (23.4)          (35.4)          (22.4)          (32.8)          (26.0)          (34.0)       |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    


       (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)

                                       TALC


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTOL                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 1    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      30    426   465   487   505   506   509   544   552   590                 |
 |      598   641   647   669   680   683   686   692   723                       |
 |  CENSORED DEATHS                                                               |
 |      641                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = CONTROL LUNG TOX                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 39     UNCENSORED DEATHS 9      CENSORED DEATHS 23   TERMINAL 7         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      28    404   504   532   576   694   701   711   715                       |
 |  CENSORED DEATHS                                                               |
 |      185   185   186   186   186   186   187   187   368   368                 |
 |      369   369   369   369   369   549   549   549   549   549                 |
 |      549   550   550                                                           |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 6 MG/M3                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 49     UNCENSORED DEATHS 25     CENSORED DEATHS 1    TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      20    92    422   491   500   534   548   554   559   564                 |
 |      618   621   628   641   645   665   676   678   686   692                 |
 |      699   709   709   712   714                                               |
 |  CENSORED DEATHS                                                               |
 |      622                                                                       |
 |                                                                                |
 ==================================================================================

                                       TALC


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 6 MG/M3 LUNG TOX                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 40     UNCENSORED DEATHS 10     CENSORED DEATHS 24   TERMINAL 6         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      4     17    453   523   617   655   659   678   697   717                 |
 |  CENSORED DEATHS                                                               |
 |      185   185   186   186   187   187   187   187   368   368                 |
 |      369   369   369   369   369   369   549   549   549   549                 |
 |      549   549   550   550                                                     |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 18 MG/M3                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 25     CENSORED DEATHS 0    TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      20    28    28    28    28    28    28    473   508   516                 |
 |      548   554   558   569   581   642   646   655   661   665                 |
 |      686   692   706   716   718                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 18 MG/M3LUNG TOX                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 40     UNCENSORED DEATHS 11     CENSORED DEATHS 24   TERMINAL 5         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      28    28    28    28    114   286   495   508   546   604                 |
 |      722                                                                       |
 |  CENSORED DEATHS                                                               |
 |      185   185   186   186   187   187   187   187   368   368                 |
 |      369   369   369   369   369   369   549   549   549   549                 |
 |      549   549   550   550                                                     |
 |                                                                                |
 ==================================================================================

                                       TALC


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTOL     |    98.0  98.0  98.0  98.0  98.0  94.0  84.0  78.0  73.9  61.6      |
 |           |                                                                    |
 |           |                                                                    |
 |CONTROL    |    97.4  97.4  97.4  97.4  93.2  93.2  84.7  77.7  77.7  49.4      |
 |LUNG TOX   |                                                                    |
 |           |                                                                    |
 |6 MG/M3    |    98.0  95.9  95.9  95.9  93.9  93.9  87.8  79.6  67.1  48.2      |
 |           |                                                                    |
 |           |                                                                    |
 |6          |    95.0  95.0  95.0  95.0  95.0  90.7  86.4  86.4  64.8  43.2      |
 |MG/M3 LUNG |OX                                                                  |
 |           |                                                                    |
 |18 MG/M3   |    86.0  86.0  86.0  86.0  86.0  84.0  80.0  70.0  60.0  50.0      |
 |           |                                                                    |
 |           |                                                                    |
 |18         |    90.0  87.5  87.5  84.3  84.3  84.3  74.9  60.2  60.2  50.2      |
 |MG/M3LUNG T|X                                                                   |
 |           |                                                                    |
 ==================================================================================

                                       TALC


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


 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                          DOSE                                               |
 |                                                                                                                             |
 |                                CONTOL          CONTROL         6 MG/M3         6               18 MG/M3        18           |
 |                                                LUNG TOX                        MG/M3 LUNG TOX                  MG/M3LUNG TOX|
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       61.6%           49.4%           48.2%           43.2%           50.0%           50.2%        |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.161          -----          P=0.322         P=0.441         P=0.286         P=0.211      |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       559.6           540.6           575.1           502.0           451.3           307.9        |
 |NATURAL DEATHS (C)      |       (35.9)          (73.9)          (35.1)          (85.8)          (55.6)          (82.1)       |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       662.9           472.6           648.3           455.7           590.1           396.7        |
 |(STANDARD ERROR)        |       (17.8)          (33.6)          (20.9)          (34.4)          (33.9)          (35.2)       |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    


       (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)

                                                                TALC
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        CONTROL LUNG TOX = 2
                                                        6 MG/M3          = 3
                                                        6 MG/M3 LUNG TOX = 4
                                                        18 MG/M3         = 5
                                                        18 MG/M3LUNG TOX = 6

------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------

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

      |
      |
  100 + 1 1 5  2           6                     3                 4
      |
      |   1 5  2           5                           2                   1
      |                                          3         3       4       11                   4
   95 +
      |                    5     5                     2   3   3            11                            2
      |                    6     5        6                                5
      |                                                        3           3 1       1
   90 +                                                                    3 5                3
      |                                   6                                                    64         4
P     |                                                                      5   5   1   1    33          2              2
E     |                                                                          5  5
R  85 +                                                                                  1    133
C     |                                                                             5        51 3 1 3
E     |                                                                                      556  6       4       4
N     |                                                                                           113 3
T  80 +                                                                                       5 5                        2   2
      |                                                                                            11
S     |                                                                                         5     3    3   5
U     |                                                                                                        5  5
R  75 +                                                                                                           44
V     |                                                                                           6   6           5      5
I     |                                                                                             1      13
V     |                                                                                                    13      13    55
A  70 +
L     |                                                                                                            11    4
      |
      |                                                                                               6       6     13  1 5  5
   65 +                                                                                                              3  1    1
      |
      |                                                                                                                 33
      |                                                                                                                  4   4
   60 +                                                                                                                  33
      |                                                                                                                   3  3
      |                                                                                                       6              6
      |
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 10 obs hidden.

                                                                TALC
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTOL           = 1
                                                        CONTROL LUNG TOX = 2
                                                        6 MG/M3          = 3
                                                        6 MG/M3 LUNG TOX = 4
                                                        18 MG/M3         = 5
                                                        18 MG/M3LUNG TOX = 6

----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------

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

      |
      |
  100 + 14 32 1
      |  4 32 1        3                                                2  1
      |    4           3                                                   1    4 1  13
      |                                                                 2            1321
P  90 +     6              6                                                    4      2   423
E     |                    6                         6                                     4 3 3          4
R     |     5                                        6                             5  6 1   2 113  2
C     |                                                                                 55     133    1
E  80 +                                                                               6 65     5 3    11  3    4
N     |                                                                                        55  2   1     1        2
T     |                                                                                 6     6 5 5       33 11   1
      |                                                                                           55       3 334 41 1
S  70 +                                                                                       6    5    6    53  3    22
U     |                                                                                                      55  3 3
R     |                                                                                                       55 4 411
V     |                                                                                                            331 22 1 1
I  60 +                                                                                                 6        5  33    6
V     |                                                                                                            4533 22
A     |                                                                                                              5 5 5
L     |
   50 +                                                                                                               4  26 2
      |                                                                                                                 3   3
      |
      |                                                                                                                  4  4
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 35 obs hidden.