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TDMS Study 96022-02 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                        TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118)                     DATE: 06/10/04       
EXPERIMENT: 96022 TEST: 02                                                                                     TIME: 09:05:08       
TEST TYPE:  CHRONIC                                                                                            PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96022       
PATHOLOGIST: MISSING                                                                                           CAS: TEFPCBMIX       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 NG /  0 UG                                                                  
                                       INCLUDE 002    80 NG  /10 UG                                                                 
                                       INCLUDE 003    240 NG /30 UG                                                                 
                                       INCLUDE 004    800 NG /100 UG                                                                
                                       INCLUDE 005    2400 NG/300 UG                                                                
                                       INCLUDE 006    4000 NG/500 UG                                                                
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                        TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118)                     DATE: 06/10/04       
EXPERIMENT: 96022 TEST: 02                                                                                     TIME: 09:05:08       
TEST TYPE:  CHRONIC                                                                                                                 
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96022       
PATHOLOGIST: MISSING                                                                                           CAS: TEFPCBMIX       
                                                                                                                                   
                   TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118)                                                                     
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 726 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 0 NG /  0 UG                                   |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 98     UNCENSORED DEATHS 26     CENSORED DEATHS 45   TERMINAL 27        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      275   313   362   482   534   534   548   555   564   567                 |                                                 
 |      582   586   623   628   628   639   639   649   651   665                 |                                                 
 |      672   687   687   688   707   707                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      92    92    92    92    92    92    92    92    92    92                  |                                                 
 |      93    93    93    93    93    93    216   216   216   216                 |                                                 
 |      216   216   216   216   216   216   217   217   217   217                 |                                                 
 |      217   217   365   365   365   365   365   365   365   365                 |                                                 
 |      366   366   366   366   366                                               |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 80 NG  /10 UG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 86     UNCENSORED DEATHS 34     CENSORED DEATHS 35   TERMINAL 17        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      70    78    275   328   347   364   374   400   436   443                 |                                                 
 |      484   485   498   525   525   534   534   541   567   594                 |                                                 
 |      611   616   623   631   639   642   651   659   659   683                 |                                                 
 |      691   700   705   714                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      92    92    92    92    92    92    92    92    92    92                  |                                                 
 |      216   216   216   216   216   216   216   216   216   216                 |                                                 
 |      365   365   365   365   365   365   365   366   366   366                 |                                                 
 |      366   366   547   547   547                                               |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 240 NG /30 UG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 98     UNCENSORED DEATHS 29     CENSORED DEATHS 45   TERMINAL 24        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      63    399   408   426   443   443   455   471   474   504                 |                                                 
 |      523   548   558   565   567   567   572   572   586   608                 |                                                 
 |      611   632   639   651   659   659   700   703   707                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      92    92    92    92    92    92    92    92    92    92                  |                                                 
 |      93    93    93    93    93    93    216   216   216   216                 |                                                 
 |      216   216   216   216   216   216   217   217   217   217                 |                                                 
 |      217   217   365   365   365   365   365   365   365   365                 |                                                 
 |      366   366   366   366   366                                               |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                   TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118)                                                                     
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 726 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 800 NG /100 UG                                 |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 86     UNCENSORED DEATHS 36     CENSORED DEATHS 35   TERMINAL 15        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      78    261   367   480   534   537   539   541   548   552                 |                                                 
 |      555   565   567   570   594   602   604   619   628   636                 |                                                 
 |      651   653   656   659   659   662   663   667   678   686                 |                                                 
 |      687   698   707   707   710   714                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      41    92    92    92    92    92    92    92    92    92                  |                                                 
 |      92    216   216   216   216   216   216   216   216   216                 |                                                 
 |      216   365   365   365   365   365   365   365   365   366                 |                                                 
 |      366   366   366   366   390                                               |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 2400 NG/300 UG                                 |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 98     UNCENSORED DEATHS 53     CENSORED DEATHS 45   TERMINAL 0         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      166   267   313   337   349   373   383   397   446   447                 |                                                 
 |      450   450   474   474   479   482   496   504   520   523                 |                                                 
 |      525   527   530   530   534   536   548   555   555   565                 |                                                 
 |      565   567   572   575   579   582   602   611   623   632                 |                                                 
 |      639   639   639   639   649   667   672   674   674   674                 |                                                 
 |      686   709   709                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      92    92    92    92    92    92    92    92    92    92                  |                                                 
 |      93    93    93    93    93    93    216   216   216   216                 |                                                 
 |      216   216   216   216   216   216   217   217   217   217                 |                                                 
 |      217   217   365   365   365   365   365   365   365   365                 |                                                 
 |      366   366   366   366   366                                               |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 4000 NG/500 UG                                 |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 86     UNCENSORED DEATHS 66     CENSORED DEATHS 20   TERMINAL 0         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      51    91    174   203   209   217   222   226   233   236                 |                                                 
 |      237   243   243   245   254   260   267   267   267   267                 |                                                 
 |      275   278   279   289   289   289   294   294   300   303                 |                                                 
 |      313   313   321   329   329   336   337   338   342   349                 |                                                 
 |      356   362   362   383   383   406   410   415   423   429                 |                                                 
 |      446   452   453   456   461   478   482   482   491   504                 |                                                 
 |      504   513   524   545   611   636                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      92    92    92    92    92    92    92    92    92    92                  |                                                 
 |      216   216   216   216   216   216   216   216   216   216                 |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                   TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118)                                                                     
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 726 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   726 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0          |   100.0 100.0 100.0  95.5  95.5  93.5  89.7  78.3  63.0  51.5      |                                                 
 |NG /  0 UG |                                                                    |                                                 
 |           |                                                                    |                                                 
 |80         |    97.7  97.7  97.7  91.6  87.8  80.1  68.7  64.5  45.8  35.4      |                                                 
 |NG  /10 UG |                                                                    |                                                 
 |           |                                                                    |                                                 
 |240        |    99.0  99.0  99.0  99.0  95.2  83.8  79.9  64.7  51.4  45.7      |                                                 
 |NG /30 UG  |                                                                    |                                                 
 |           |                                                                    |                                                 
 |800        |    98.8  98.8  97.3  97.3  95.3  93.3  85.4  67.5  47.7  29.8      |                                                 
 |NG /100 UG |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2400       |   100.0  98.8  97.3  92.7  86.9  71.5  52.1  30.9  15.5   0.0      |                                                 
 |NG/300 UG  |                                                                    |                                                 
 |           |                                                                    |                                                 
 |4000       |    98.8  96.4  70.7  35.3  26.1  12.3   3.1   3.1   0.0   0.0      |                                                 
 |NG/500 UG  |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                   TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118)                                                                     
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 726 DAYS                                                                         
 ===============================================================================================================================    
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |    
 |                                                                                                                             |    
 |                                                                                                                             |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |                                                                          DOSE                                               |    
 |                                                                                                                             |    
 |                                0               80              240             800             2400            4000         |    
 |                                NG /  0 UG      NG  /10 UG      NG /30 UG       NG /100 UG      NG/300 UG       NG/500 UG    |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |SURVIVAL AT END OF STUDY|       51.5%           35.4%           45.7%           29.8%            0.0%            0.0%        |    
 |(KAPLAN-MEIER)          |                                                                                                    |    
 |                        |                                                                                                    |    
 |SIGNIFICANCE (B)        |       P<0.001         P=0.055         P=0.457         P=0.054         P<0.001         P<0.001      |    
 |(LIFE TABLE)            |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN DAY OF             |       583.5           518.4           541.8           589.8           534.2           342.1        |    
 |NATURAL DEATHS (C)      |       (22.6)          (28.2)          (24.1)          (21.6)          (16.1)          (14.3)       |    
 |(STANDARD ERROR)        |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN LIFE SPAN (D)      |       453.7           454.3           437.0           469.6           387.8           298.3        |    
 |(STANDARD ERROR)        |       (24.8)          (24.2)          (24.1)          (24.8)          (19.8)          (14.3)       |    
 |                        |                                                                                                    |    
 ===============================================================================================================================    
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                            TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118)                                            
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 NG /  0 UG     = 1                                                        
                                                        80 NG  /10 UG    = 2                                                        
                                                        240 NG /30 UG    = 3                                                        
                                                        800 NG /100 UG   = 4                                                        
                                                        2400 NG/300 UG   = 5                                                        
                                                        4000 NG/500 UG   = 6                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
  100 + 1        632 26           5               451                  3                                                            
      |              26             6   6         451     1      14    3 3                                                          
      |                                 66          2     5 2 52 14      3 3        1                                               
      |                                  666                   2 2 2       3  3     1        1                                      
   90 +                                    666                     2 5 52     3 3            1 1                                    
      |                                                                52    25 3  3         4411                                   
      |                                      6 6                             22    3 2 3      4411                                  
      |                                                                       5 5      3   3   441  1                               
   80 +                                        6 6                              5  5 2 2   3   344                                  
      |                                          666                                   2   2   33   1     11                        
      |                                                                            55      2 2  334                                 
      |                                                                             5 5           4   44   1 1                      
P  70 +                                            66                                 55     22  33    44                           
E     |                                                                                5   5  2  23 3 2 4 4  11                     
R     |                                             6 6                                             3 2 3244  1  1                  
C     |                                                                                    55           33 44 4  11                 
E  60 +                                                                                                  22 3344  1  1              
N     |                                               666                                                 2 233                     
T     |                                                 6 6                                 55              2234 3   1 1            
      |                                                   66                                 5 5             22  3    31  1         
S  50 +                                                    66                                  55             2  2    33            
U     |                                                     66                                  55               44                 
R     |                                                      66                                                  2442  3  3         
V     |                                                       66                                                   4222             
I  40 +                                                        66                                55                  422            
V     |                                                         66                                55                  422           
A     |                                                          6   6                             55                  42 2         
L     |                                                              6  6                           5  5                            
   30 +                                                                 666                            5 55             4 4         
      |                                                                   66                              5 5                       
      |                                                                    66 6                             55                      
      |                                                                       6 6                                                   
   20 +                                                                         66                                                  
      |                                                                          6  6                        55                     
      |                                                                                                       5   5                 
      |                                                                             6 6                           55                
   10 +                                                                               66                                            
      |                                                                                6 6                                          
      |                                                                                  6 6  6                    55   5           
      |                                                                                       6          6  6                       
    0 +                                                                                                     6           5           
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 52 obs hidden.