TDMS Study 55301-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: TSI Mason Research PYRIDINE DATE: 11/19/96 EXPERIMENT: 55301 TEST: 04 TIME: 16:09:03 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-95268 ROUTE: DOSED WATER NTP C#: 55301B PATHOLOGIST: F. VOELKER STEDHAM, MICHAEL CAS: 110-86-1 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: TSI Mason Research PYRIDINE DATE: 11/19/96 EXPERIMENT: 55301 TEST: 04 TIME: 16:09:03 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-95268 ROUTE: DOSED WATER NTP C#: 55301B PATHOLOGIST: F. VOELKER STEDHAM, MICHAEL CAS: 110-86-1 PYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 722 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 13 CENSORED DEATHS 2 TERMINAL 35 | | | | UNCENSORED DEATHS | | 520 542 598 621 633 637 639 653 663 670 | | 672 706 714 | | CENSORED DEATHS | | 118 574 | | | |--------------------------------------------------------------------------------| | DOSE = 250 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 21 CENSORED DEATHS 1 TERMINAL 28 | | | | UNCENSORED DEATHS | | 237 522 532 546 549 561 587 591 595 608 | | 638 645 650 674 676 677 680 692 696 702 | | 715 | | CENSORED DEATHS | | 8 | | | |--------------------------------------------------------------------------------| | DOSE = 500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 1 TERMINAL 35 | | | | UNCENSORED DEATHS | | 226 513 514 526 586 623 630 637 642 643 | | 657 661 664 708 | | CENSORED DEATHS | | 3 | | | ================================================================================== PYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 722 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 3 TERMINAL 35 | | | | UNCENSORED DEATHS | | 406 432 594 624 639 649 665 672 680 686 | | 699 709 | | CENSORED DEATHS | | 3 9 59 | | | ================================================================================== PYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 722 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 722 (A) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 95.9 93.8 81.3 73.0 | | | | | | | |250 PPM | 100.0 100.0 98.0 98.0 98.0 98.0 93.9 81.6 73.5 57.1 | | | | | | | |500 PPM | 100.0 100.0 98.0 98.0 98.0 98.0 91.8 89.8 73.5 71.4 | | | | | | | |1000 PPM | 100.0 100.0 100.0 100.0 97.9 95.7 95.7 93.6 85.1 74.5 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 250 PPM 500 PPM 1000 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 73.0% 57.1% 71.4% 74.5% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.507N P=0.138 P=0.928 P=1.000N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 636.0 608.2 587.9 621.3 | |NATURAL DEATHS (C) | (15.7) (22.8) (32.1) (28.8) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 684.6 659.9 670.1 655.9 | |(STANDARD ERROR) | (13.6) (18.2) (18.3) (24.6) | | | | ================================================================================== (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) PYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 15 CENSORED DEATHS 3 TERMINAL 32 | | | | UNCENSORED DEATHS | | 375 476 565 568 625 644 644 662 670 687 | | 691 697 711 714 719 | | CENSORED DEATHS | | 64 151 554 | | | |--------------------------------------------------------------------------------| | DOSE = 125 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 6 TERMINAL 30 | | | | UNCENSORED DEATHS | | 372 573 599 605 608 642 649 674 677 680 | | 696 711 713 724 | | CENSORED DEATHS | | 4 16 20 172 419 555 | | | |--------------------------------------------------------------------------------| | DOSE = 250 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 24 CENSORED DEATHS 4 TERMINAL 22 | | | | UNCENSORED DEATHS | | 417 509 556 564 583 624 632 633 642 648 | | 659 678 684 692 696 697 699 700 700 708 | | 712 722 723 727 | | CENSORED DEATHS | | 3 33 40 175 | | | ================================================================================== PYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 5 TERMINAL 29 | | | | UNCENSORED DEATHS | | 14 299 366 479 510 526 595 615 626 677 | | 680 686 690 690 700 703 | | CENSORED DEATHS | | 12 15 188 430 571 | | | ================================================================================== PYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE 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 PPM | 100.0 100.0 100.0 100.0 97.9 95.8 95.8 91.6 83.1 68.1 | | | | | | | |125 PPM | 100.0 100.0 100.0 100.0 97.8 97.8 97.8 91.0 84.2 68.3 | | | | | | | |250 PPM | 100.0 100.0 100.0 100.0 97.8 97.8 95.7 89.1 76.1 47.8 | | | | | | | |500 PPM | 98.0 98.0 98.0 95.8 93.7 91.5 87.2 84.9 80.5 64.8 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 125 PPM 250 PPM 500 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 68.1% 68.3% 47.8% 64.8% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.487 P=1.000N P=0.090 P=0.755 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 629.9 637.4 650.2 553.5 | |NATURAL DEATHS (C) | (25.2) (24.0) (15.7) (47.4) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 670.9 639.6 637.9 624.3 | |(STANDARD ERROR) | (19.4) (27.1) (26.0) (28.0) | | | | ================================================================================== (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) PYRIDINE KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 250 PPM = 2 500 PPM = 3 1000 PPM = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 106.12 + | | |1 32 4 1 P 97.96 + 32 4 4 3 1 1 E | 4 22 1 41 R | 3 2 2 41 14 C | 3 22 3 1414 E 89.80 + 2 2 3 3 44 N | 2 2 33114 4 T | 2 2 331 1 44 | 33 1 14 4 S 81.63 + 2 2 11 U | 2 2 3 4 4 R | 223 31 414 V | 11 I 73.47 + 2 3 2 1 1 V | 3 3 A | L | 22 65.31 + 22 | 22 | 22 | 2 2 57.14 + 22 | -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+ 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 9 obs hidden. PYRIDINE KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 125 PPM = 2 250 PPM = 3 500 PPM = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 1 3 | 4 4 1 3 1 3 2 | 4 4 1 3 312 2 | 4 4 4 311 3 22 1 P 90 + 4 4 3 1 1 E | 4 4 2 3322 R | 4 4 12 1 2 C | 4 433 11 E 80 + 4 33 1221 N | 3 3 4211 T | 3 3341 1 | 33 S 70 + 33 112 U | 44 12 1 R | 4 4 V | I 60 + V | 3 3 A | 3 3 L | 50 + | 3 3 | | 40 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 22 obs hidden.