https://ntp.niehs.nih.gov/go/1559

TDMS Study 05162-10 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                       DIETHANOLAMINE                                    DATE: 06/11/96       
EXPERIMENT: 05162 TEST: 10                                                                                     TIME: 13:02:59       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-05293                              ROUTE: SKIN APPLICATION                                        NTP C#: 55174D       
PATHOLOGIST: PERSING, R.                                                                                       CAS: 111-42-2        
------------------------------------------------------------------------------------------------------------------------------------
                                                             CORE STUDY                                                             
               REASONS FOR REMOVAL:    ALL                                                                                          
               REMOVAL DATE RANGE:     ALL                                                                                          
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Columbus                                       DIETHANOLAMINE                                    DATE: 06/11/96      
EXPERIMENT: 05162 TEST: 10                                                                                     TIME: 13:02:59      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-05293                              ROUTE: SKIN APPLICATION                                        NTP C#: 55174D      
PATHOLOGIST: PERSING, R.                                                                                       CAS: 111-42-2       
                                  DIETHANOLAMINE
                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      411   473   485   593   596   611   649   674   678   716                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 40 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 7      CENSORED DEATHS 0    TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      499   576   641   670   692   706   723                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 80 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      445   556   558   583   599   631   633   641   654   667                 |
 |      681   685   699   701   715   724                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  DIETHANOLAMINE
                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 160     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 1    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      386   446   540   598   605   606   634   660   674   684                 |
 |      696   700   706   716   717   719   719   719   723                       |
 |  CENSORED DEATHS                                                               |
 |      230                                                                       |
 |                                                                                |
 ==================================================================================
                                  DIETHANOLAMINE
                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE 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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0 100.0  98.0  94.0  94.0  90.0  86.0  80.0      |
 |           |                                                                    |
 |           |                                                                    |
 |40 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  96.0  94.0  86.0      |
 |           |                                                                    |
 |           |                                                                    |
 |80 MG/KG   |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  90.0  82.0  68.0      |
 |           |                                                                    |
 |           |                                                                    |
 |160        |   100.0 100.0 100.0 100.0  98.0  95.9  93.9  89.8  83.7  61.2      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      40 MG/KG     80 MG/KG     160      |
 |                                                                       MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       80.0%        86.0%        68.0%        61.2%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.015      P=0.539N     P=0.289      P=0.097  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       588.6        643.9        635.8        644.6    |
 |NATURAL DEATHS (C)      |       (31.9)       (30.4)       (18.4)       (22.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       700.9        717.1        699.2        687.0    |
 |(STANDARD ERROR)        |       (10.1)       ( 5.8)       ( 8.5)       (13.8)   |
 |                        |                                                       |
 ==================================================================================
       (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)
                                  DIETHANOLAMINE
                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 6      CENSORED DEATHS 0    TERMINAL 44        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      508   576   659   674   692   729                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 40 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      418   421   423   424   458   491   514   526   527   534                 |
 |      599   610   649   655   689   691   696                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 80 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      474   539   540   556   568   600   614   614   626   633                 |
 |      638   684   684   696   712   725   730                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  DIETHANOLAMINE
                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 160     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 27     CENSORED DEATHS 0    TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      522   585   593   594   599   606   606   607   607   611                 |
 |      631   641   658   674   681   694   696   701   701   709                 |
 |      714   716   716   717   721   724   726                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  DIETHANOLAMINE
                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   731 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  96.0  94.0  88.0      |
 |           |                                                                    |
 |           |                                                                    |
 |40 MG/KG   |   100.0 100.0 100.0 100.0  92.0  90.0  80.0  78.0  72.0  66.0      |
 |           |                                                                    |
 |           |                                                                    |
 |80 MG/KG   |   100.0 100.0 100.0 100.0 100.0  98.0  94.0  88.0  78.0  66.0      |
 |           |                                                                    |
 |           |                                                                    |
 |160        |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  90.0  74.0  46.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      40 MG/KG     80 MG/KG     160      |
 |                                                                       MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       88.0%        66.0%        66.0%        46.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.012      P=0.016      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       639.7        548.5        625.5        657.4    |
 |NATURAL DEATHS (C)      |       (33.5)       (24.9)       (17.9)       (11.0)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       720.0        669.0        695.1        691.3    |
 |(STANDARD ERROR)        |       ( 5.6)       (14.9)       ( 9.3)       ( 7.9)   |
 |                        |                                                       |
 ==================================================================================
       (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)
                                                           DIETHANOLAMINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        40 MG/KG         = 2
                                                        80 MG/KG         = 3
                                                        160     MG/KG    = 4
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.
      |
      |
  100 + 1                                                             4  1    3        2
      |
      |                                                               4  1    3    1   2        3  2
      |                                                                       4    1 1        4    2         2
   95 +
      |                                                                              1        4 3   3 14     2    2
      |                                                                                             3 11          2  2
      |                                                                                                44
P  90 +                                                                                                1 1  3        2 2
E     |
R     |                                                                                                 41  4 1        2  2
C     |                                                                                                     331  4 1      2 2
E  85 +
N     |                                                                                                      3 3 4 4
T     |                                                                                                        3  31     1
      |                                                                                                            44
S  80 +                                                                                                           3 3 4  1  1
U     |
R     |
V     |                                                                                                             3 3
I  75 +                                                                                                               44
V     |                                                                                                               33 4
A     |                                                                                                                3 3
L     |
   70 +                                                                                                                  33
      |
      |                                                                                                                   3 3
      |
   65 +
      |                                                                                                                  44
      |
      |                                                                                                                   4 4
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110
                                                                   WEEK
NOTE: 9 obs hidden.
                                                           DIETHANOLAMINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        40 MG/KG         = 2
                                                        80 MG/KG         = 3
                                                        160     MG/KG    = 4
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.
      |
      |
  100 + 1                                                                 2        3    1  4
      |                                                                   22       3    1  4 3     14
      |                                                                                      33 3  14 4          1 1
      |                                                                    2     2              3 3   44           1 1
P  90 +                                                                          2    2           3    34            1      1
E     |                                                                               2  2             3 3                  1
R     |                                                                                  2  2            3 3
C     |                                                                                     22          44 33
E  80 +                                                                                      2         2 4  33
N     |                                                                                                2 2  43      3
T     |                                                                                                  2   422   43 3
      |                                                                                                        2   4423 3
S  70 +                                                                                                             4 4 3 3
U     |                                                                                                              22   3 3
R     |                                                                                                               24    2
V     |                                                                                                                44
I  60 +
V     |                                                                                                                 44
A     |
L     |
   50 +                                                                                                                  44
      |
      |                                                                                                                   4 4
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110
                                                                   WEEK
NOTE: 13 obs hidden.