TDMS Study 05103-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 TIME: 19:23:26 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85234 ROUTE: DOSED FEED NTP C#: 55516C PATHOLOGIST: DR J. HEATH LEININGER, JOEL CAS: 3296-90-0 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 TIME: 19:23:26 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85234 ROUTE: DOSED FEED NTP C#: 55516C PATHOLOGIST: DR J. HEATH LEININGER, JOEL CAS: 3296-90-0 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 736 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = UNTREATD CONTROL | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 8 CENSORED DEATHS 10 TERMINAL 42 | | | | UNCENSORED DEATHS | | 310 478 579 606 614 639 674 705 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 0.0312% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 15 CENSORED DEATHS 9 TERMINAL 36 | | | | UNCENSORED DEATHS | | 17 19 362 461 543 586 592 625 625 646 | | 656 678 683 705 731 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 0.0625% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 15 CENSORED DEATHS 10 TERMINAL 35 | | | | UNCENSORED DEATHS | | 45 536 572 579 626 662 666 668 669 669 | | 669 669 677 687 731 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 456 | | | ================================================================================== 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 736 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.125% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 18 CENSORED DEATHS 12 TERMINAL 30 | | | | UNCENSORED DEATHS | | 248 447 515 565 589 592 592 593 641 656 | | 669 669 669 669 703 705 725 725 | | CENSORED DEATHS | | 445 456 456 456 456 456 456 456 456 456 | | 456 690 | | | ================================================================================== 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 736 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 736 (A) | | | |--------------------------------------------------------------------------------| | | | |UNTREATD | 100.0 100.0 100.0 98.3 98.3 96.3 96.3 94.3 88.3 84.3 | |CONTROL | | | | | |0.0312% | 96.7 96.7 96.7 95.0 95.0 93.0 91.0 87.1 79.2 71.3 | | | | | | | |0.0625% | 98.3 98.3 98.3 98.3 98.3 98.3 96.3 92.3 88.3 70.2 | | | | | | | |0.125% | 100.0 100.0 98.3 98.3 98.3 96.6 94.6 84.3 80.2 63.5 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | UNTREATD 0.0312% 0.0625% 0.125% | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 84.3% 71.3% 70.2% 63.5% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.054 P=0.167 P=0.174 P=0.038 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 575.6 528.6 608.3 609.6 | |NATURAL DEATHS (C) | (44.9) (58.9) (42.3) (27.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 668.0 642.2 657.4 645.8 | |(STANDARD ERROR) | (15.3) (20.9) (17.1) (16.0) | | | | ================================================================================== (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) 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 743 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = UNTREATD CONTROL | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 15 CENSORED DEATHS 8 TERMINAL 37 | | | | UNCENSORED DEATHS | | 285 407 447 484 499 569 571 618 624 631 | | 631 640 646 648 705 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 0.0312% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 20 CENSORED DEATHS 10 TERMINAL 30 | | | | UNCENSORED DEATHS | | 1 386 513 579 606 606 608 619 625 627 | | 635 655 668 669 670 677 677 692 696 730 | | CENSORED DEATHS | | 457 457 457 457 457 457 457 457 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 0.0625% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 25 CENSORED DEATHS 9 TERMINAL 26 | | | | UNCENSORED DEATHS | | 397 428 536 543 557 575 605 620 629 639 | | 639 652 669 669 669 679 683 693 707 709 | | 711 718 719 726 733 | | CENSORED DEATHS | | 457 457 457 457 457 457 457 457 457 | | | ================================================================================== 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 743 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.125% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 39 CENSORED DEATHS 10 TERMINAL 11 | | | | UNCENSORED DEATHS | | 401 449 456 480 483 490 502 520 526 534 | | 534 537 537 551 551 554 575 576 586 606 | | 610 615 642 649 649 656 667 668 669 669 | | 669 669 669 669 672 674 677 719 733 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 456 | | | ================================================================================== 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 743 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 743 (A) | | | |--------------------------------------------------------------------------------| | | | |UNTREATD | 100.0 100.0 100.0 98.3 96.7 93.1 91.1 87.2 73.7 71.7 | |CONTROL | | | | | |0.0312% | 98.3 98.3 98.3 98.3 96.7 96.7 94.7 92.6 76.5 60.4 | | | | | | | |0.0625% | 100.0 100.0 100.0 100.0 98.3 96.7 92.7 86.8 76.9 51.3 | | | | | | | |0.125% | 100.0 100.0 100.0 100.0 98.3 91.0 74.8 62.7 48.5 22.2 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | UNTREATD 0.0312% 0.0625% 0.125% | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 71.7% 60.4% 51.3% 22.2% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P=0.432 P=0.119 P<0.001 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 560.3 597.0 636.2 592.1 | |NATURAL DEATHS (C) | (29.4) (35.5) (17.7) (13.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 659.1 646.7 655.6 597.1 | |(STANDARD ERROR) | (16.1) (18.2) (14.6) (14.0) | | | | ================================================================================== (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) 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL KAPLAN-MEIER SURVIVAL CURVES UNTREATD CONTROL = 1 0.0312% = 2 0.0625% = 3 0.125% = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 2 3 4 1 | 3 4 1 4 1 3 | | 2 2 4 1 4 3 31 95 + 2 2 4 4 | 31 1 | 2 2 4 3 4 11 3 | 2 2 P 90 + 1 3 1 3 E | 2 2 1 331 R | 2 2 C | 1 1 E 85 + N | 4 2 42 1 1 T | 4 4 | 22 S 80 + 4 4 U | 2 2 R | 22 V | 33 I 75 + 2 2 V | 3 3 2 2 A | 4 3 4 3 L | 22 70 + 33 | | 4 4 | 65 + | 4 4 | | 60 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 4 obs hidden. 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL KAPLAN-MEIER SURVIVAL CURVES UNTREATD CONTROL = 1 0.0312% = 2 0.0625% = 3 0.125% = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 12 1 34 | 2 1 2341 3 1 44 2 3 | 1 4 41 2 33 2 | 1 1 3 3 2 2 90 + 44 1 3 13 3 | 4 4 1 2 1 | 44 11 | 44 113 P 80 + 211 3 E | 2112 2 R | 4 4 C | 1 1 1 E 70 + 44 223 N | 4 4 232 T | 44 223 | 4 4 233 2 S 60 + 44 33 2 2 U | 4 4 R | 44 33 V | 3 3 3 I 50 + 44 V | 4 4 A | L | 40 + | | | 30 + 44 | 4 4 | 4 4 | 4 4 20 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 30 obs hidden.