TDMS Study 05002-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst DATE: 09/02/94 EXP: 05002 GAMMA-BUTYROLACTONE TIME: 20:03:52 TEST: 06 CAGES FROM 0000 TO LAST CAGE PAGE: 1 TEST TYPE: CHRONIC ROUTE: GAVAGE NTP C#: 55878 CONT: NO1CP9565101 CAS: 96-48-0 PATHOLOGIST: J. HEATH -------------------------------------------------------------------------------- REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst DATE: 09/02/94 EXP: 05002 GAMMA-BUTYROLACTONE TIME: 20:03:52 TEST: 06 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: GAVAGE NTP C#: 55878 CONT: NO1CP9565101 CAS: 96-48-0 PATHOLOGIST: J. HEATH GAMMA-BUTYROLACTONE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 15 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 175 385 441 473 473 540 578 582 582 601 | | 618 633 688 703 721 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 262. MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 20 CENSORED DEATHS 0 TERMINAL 30 | | | | UNCENSORED DEATHS | | 132 146 151 187 270 344 380 391 391 401 | | 412 436 519 532 584 584 605 613 656 670 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 525. MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 37 CENSORED DEATHS 1 TERMINAL 12 | | | | UNCENSORED DEATHS | | 67 108 119 119 119 159 169 169 170 171 | | 185 188 192 329 381 385 427 431 445 512 | | 514 545 568 568 568 583 585 585 597 601 | | 640 652 655 656 657 690 703 | | CENSORED DEATHS | | 93 | | | ================================================================================== GAMMA-BUTYROLACTONE 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) | | | |--------------------------------------------------------------------------------| | | | |VEHICLE | 100.0 98.0 98.0 98.0 96.0 90.0 88.0 80.0 76.0 70.0 | |CONTROL | | | | | |262. | 100.0 94.0 90.0 88.0 78.0 76.0 72.0 66.0 62.0 60.0 | |MG/KG | | | | | |525. | 98.0 79.6 73.5 71.5 67.4 61.3 55.1 38.8 28.6 24.5 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE 262. 525. | | CONTROL MG/KG MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 70.0% 60.0% 24.5% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P=0.257 P<0.001 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 546.2 420.2 411.1 | |NATURAL DEATHS (C) | (36.5) (39.2) (35.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 674.2 605.5 481.1 | |(STANDARD ERROR) | (16.0) (26.5) (33.3) | | | | ================================================================================== (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) GAMMA-BUTYROLACTONE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 0 TERMINAL 38 | | | | UNCENSORED DEATHS | | 581 584 586 592 609 610 611 617 630 655 | | 673 697 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 262. MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 0 TERMINAL 34 | | | | UNCENSORED DEATHS | | 464 477 527 551 560 591 591 592 592 617 | | 624 630 633 633 641 690 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 525. MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 0 TERMINAL 38 | | | | UNCENSORED DEATHS | | 471 511 592 592 641 643 655 656 656 693 | | 708 711 | | CENSORED DEATHS | | NONE | | | ================================================================================== GAMMA-BUTYROLACTONE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 730 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 730 (A) | | | |--------------------------------------------------------------------------------| | | | |VEHICLE | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 92.0 80.0 76.0 | |CONTROL | | | | | |262. | 100.0 100.0 100.0 100.0 100.0 96.0 94.0 82.0 70.0 68.0 | |MG/KG | | | | | |525. | 100.0 100.0 100.0 100.0 100.0 98.0 96.0 92.0 82.0 76.0 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE 262. 525. | | CONTROL MG/KG MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 76.0% 68.0% 76.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.997N P=0.436 P=1.000N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 620.4 588.3 627.4 | |NATURAL DEATHS (C) | (10.7) (15.1) (21.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 703.7 684.7 705.4 | |(STANDARD ERROR) | ( 7.1) (10.6) ( 8.0) | | | | ================================================================================== (A) FIRST TERMINAL SACRIFICE (B) THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT. SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS (COX,1972). NEGATIVE TRENDS ARE INDICATED BY "N". (C) MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE (D) MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE) GAMMA-BUTYROLACTONE KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 262. MG/KG = 2 525. MG/KG = 3 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 3 2 1 | 3 3 2 2 1 1 | 33 22 2 1 1 1 | 2 2 90 + 3 3 2 2 1 1 | 3 3 2 2 1 1 | 22 11 | 2 2 1 1 P 80 + 3 3 22 1 1 E | 2 2 1 1 R | 33 2 22 1 1 1 C | 3 3 3 2 2 1 1 E 70 + 1 1 N | 3 3 2 2 T | 33 22 2 | 3 3 3 2 2 S 60 + 2 2 U | 3 3 R | 3 3 V | I 50 + 3 3 V | A | L | 3 3 40 + 3 3 | 3 3 | | 30 + | 3 3 3 | 3 3 | 20 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 10 obs hidden. GAMMA-BUTYROLACTONE KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 262. MG/KG = 2 525. MG/KG = 3 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 23 1 | | 232 3 11 | 2 3 2 3 95 + | 2 2 1 1 P | 22 1 1 3 E | R 90 + 2 2 11 C | E | 3 3 N | 11 T 85 + | 11 S | 2 21 1 3 U | R 80 + 22 1 1 3 3 V | I | 1 1 V | 22 1 3 1 A 75 + L | | 22 | 70 + 2 2 | | 2 2 | 65 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 5 obs hidden.