National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/14521

TDMS Study 99039-01 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: BIORELIANCE                                     TRANSGENIC MODEL EVALUATION II                            DATE: 02/21/03       
EXPERIMENT: 99039 TEST: 01                                                                                     TIME: 10:25:00       
TEST TYPE:  26-39 WEEKS                         CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75408                              ROUTE: DOSED FEED                                              NTP C#: C99039       
PATHOLOGIST: LANNING, LYNDA                                                                                    CAS: 55589-62-3      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                         FINAL#3/TG.AC MICE                                                         
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    VEHICLE CONTROL                                                               
                                       INCLUDE 002    0.3%                                                                          
                                       INCLUDE 003    1.0 %                                                                         
                                       INCLUDE 004    3.0 %                                                                         
                                       INCLUDE 006    VEHICLE CONTROL                                                               
                                       INCLUDE 007    0.3 %                                                                         
                                       INCLUDE 008    1.0%                                                                          
                                       INCLUDE 009    3.0%                                                                          
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: BIORELIANCE                                     TRANSGENIC MODEL EVALUATION II                            DATE: 02/21/03       
EXPERIMENT: 99039 TEST: 01                                                                                     TIME: 10:25:00       
TEST TYPE:  26-39 WEEKS                         CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75408                              ROUTE: DOSED FEED                                              NTP C#: C99039       
PATHOLOGIST: LANNING, LYNDA                                                                                    CAS: 55589-62-3      
                                                                                                                                   
              TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 274 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = VEHICLE CONTROL                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 13        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      148   157                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 0.3%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 4      CENSORED DEATHS 0    TERMINAL 11        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      71    148   233   271                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1.0 %                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 13        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      192   264                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
              TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 274 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 3.0 %                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 1      CENSORED DEATHS 0    TERMINAL 14        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      172                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
              TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 274 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 28    56    84   112   140   168   196   224   252   274 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0  86.7  86.7  86.7  86.7  86.7      |                                                 
 |CONTROL    |                                                                    |                                                 
 |           |                                                                    |                                                 
 |0.3%       |   100.0 100.0  93.3  93.3  93.3  86.7  86.7  86.7  80.0  73.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.0 %      |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  93.3  93.3  86.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |3.0 %      |   100.0 100.0 100.0 100.0 100.0 100.0  93.3  93.3  93.3  93.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                VEHICLE      0.3%         1.0 %        3.0 %    |                                                 
 |                                CONTROL                                         |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       86.7%        73.3%        86.7%        93.3%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.430N     P=0.638      P=1.000N     P=0.951N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       152.5        180.8        228.0        172.0    |                                                 
 |NATURAL DEATHS (C)      |       ( 4.5)       (44.7)       (36.0)       (  . )   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       257.8        249.1        267.9        267.2    |                                                 
 |(STANDARD ERROR)        |       (11.0)       (15.4)       ( 5.5)       ( 6.8)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
              TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 274 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = VEHICLE CONTROL                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 12        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      224   236   240                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 0.3 %                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 12        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      77    196   256                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1.0%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 12        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      207   232   270                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
              TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 274 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 3.0%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 12        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      156   232   255                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
              TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 274 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 28    56    84   112   140   168   196   224   252   274 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  80.0  80.0      |                                                 
 |CONTROL    |                                                                    |                                                 
 |           |                                                                    |                                                 
 |0.3 %      |   100.0 100.0  93.3  93.3  93.3  93.3  93.3  86.7  86.7  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.0%       |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  93.3  86.7  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |3.0%       |   100.0 100.0 100.0 100.0 100.0  93.3  93.3  93.3  86.7  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                VEHICLE      0.3 %        1.0%         3.0%     |                                                 
 |                                CONTROL                                         |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       80.0%        80.0%        80.0%        80.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=1.000      P=1.000      P=1.000      P=1.000  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       233.3        176.3        236.3        214.3    |                                                 
 |NATURAL DEATHS (C)      |       ( 4.8)       (52.6)       (18.3)       (29.9)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       265.9        254.5        266.5        262.1    |                                                 
 |(STANDARD ERROR)        |       ( 4.4)       (13.7)       ( 5.1)       ( 8.1)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                       TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                                       
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        VEHICLE CONTROL  = 1                                                        
                                                        0.3%             = 2                                                        
                                                        1.0 %            = 3                                                        
                                                        3.0 %            = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
         |                                                                                                                          
         |                                                                                                                          
P 100.00 +1                                2                                1        4        3                                     
E        |                                                                                                                          
R        |                                                                                                                          
C        |                                                                                                                          
E  93.33 +                                 2                                1  1     4        3                             3     4 
N        |                                                                                                                          
T        |                                                                                                                          
         |                                                                                                                          
S  86.67 +                                                                  2  1                                2           3     1 
U        |                                                                                                                          
R        |                                                                                                                          
V        |                                                                                                                          
I  80.00 +                                                                                                      2              2    
V        |                                                                                                                          
A        |                                                                                                                          
L        |                                                                                                                          
   73.33 +                                                                                                                     2  2 
         |                                                                                                                          
         -+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+-
          0  1  2  3  4  5  6  7  8  9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 
                                                                                                                                    
                                                                     WEEK                                                           
                                                                                                                                    
NOTE: 5 obs hidden.                                                                                                                 
                                                                                                                                   
                                       TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                                       
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        VEHICLE CONTROL  = 1                                                        
                                                        0.3 %            = 2                                                        
                                                        1.0%             = 3                                                        
                                                        3.0%             = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      P        |                                                                                                                    
      E        |                                                                                                                    
      R 100.00 +  1                            2                              4                 3    1                              
      C        |                                                                                                                    
      E        |                                                                                                                    
      N        |                                                                                                                    
      T  93.33 +                               2                              4            2    3    1    1                         
               |                                                                                                                    
      S        |                                                                                                                    
      U        |                                                                                                                    
      R  86.67 +                                                                           2              1  1    2    3            
      V        |                                                                                                                    
      I        |                                                                                                                    
      V        |                                                                                                                    
      A  80.00 +                                                                                             1    2    3  1         
      L        |                                                                                                                    
               ---+------------+------------+------------+------------+------------+------------+------------+------------+--       
                  0            5           10           15           20           25           30           35           40         
                                                                                                                                    
                                                                    WEEK                                                            
                                                                                                                                    
NOTE: 12 obs hidden.                                                                                                                
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