TDMS Study 05068-09 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Microbiological Assoc. CODEINE DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 TIME: 20:09:10 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-75178 ROUTE: DOSED FEED NTP C#: 61541B PATHOLOGIST: L. BRENNECKE CAS: 76-57-3 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Microbiological Assoc. CODEINE DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 TIME: 20:09:10 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-75178 ROUTE: DOSED FEED NTP C#: 61541B PATHOLOGIST: L. BRENNECKE CAS: 76-57-3 CODEINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 732 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 21 CENSORED DEATHS 10 TERMINAL 29 | | | | UNCENSORED DEATHS | | 203 334 446 449 495 500 525 554 567 599 | | 601 636 643 652 657 662 670 681 684 700 | | 720 | | CENSORED DEATHS | | 455 455 455 455 455 455 455 455 455 455 | | | |--------------------------------------------------------------------------------| | DOSE = 400 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 30 CENSORED DEATHS 10 TERMINAL 20 | | | | UNCENSORED DEATHS | | 336 404 426 549 574 586 608 615 615 624 | | 627 632 641 651 651 657 658 678 678 679 | | 684 684 693 695 701 706 707 711 720 729 | | CENSORED DEATHS | | 455 455 455 455 455 455 455 455 455 455 | | | |--------------------------------------------------------------------------------| | DOSE = 800 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 29 CENSORED DEATHS 10 TERMINAL 21 | | | | UNCENSORED DEATHS | | 519 526 546 550 559 567 574 580 608 634 | | 635 638 638 638 655 658 658 665 687 687 | | 695 706 707 712 720 720 722 726 726 | | CENSORED DEATHS | | 455 455 455 455 455 455 455 455 455 455 | | | ================================================================================== CODEINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 732 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1600 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 30 CENSORED DEATHS 10 TERMINAL 20 | | | | UNCENSORED DEATHS | | 355 383 484 530 537 543 544 550 559 571 | | 582 585 594 603 621 659 659 670 670 683 | | 687 700 701 705 705 708 715 729 730 731 | | CENSORED DEATHS | | 455 455 455 455 455 455 455 455 455 455 | | | ================================================================================== CODEINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 732 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 732 (A) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 100.0 100.0 98.3 96.7 96.7 93.3 87.2 79.1 69.0 58.8 | | | | | | | |400 PPM | 100.0 100.0 100.0 98.3 96.7 95.0 95.0 88.9 66.7 40.4 | | | | | | | |800 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 96.0 84.0 64.0 42.0 | | | | | | | |1600 PPM| 100.0 100.0 100.0 98.3 96.7 94.7 86.6 72.5 66.5 40.3 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 400 PPM 800 PPM 1600 P|M | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 58.8% 40.4% 42.0% 40.3% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.244 P=0.216 P=0.319 P=0.193 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 570.4 630.6 643.3 616.4 | |NATURAL DEATHS (C) | (28.5) (17.2) (12.3) (18.0) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 629.3 635.2 643.0 628.1 | |(STANDARD ERROR) | (17.0) (14.7) (13.5) (15.1) | | | | ================================================================================== (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) CODEINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 22 CENSORED DEATHS 10 TERMINAL 28 | | | | UNCENSORED DEATHS | | 313 432 475 475 490 495 532 547 548 575 | | 581 581 586 587 591 631 663 673 677 689 | | 712 725 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 400 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 12 CENSORED DEATHS 10 TERMINAL 38 | | | | UNCENSORED DEATHS | | 400 479 540 546 606 681 689 689 705 707 | | 712 731 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 800 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 22 CENSORED DEATHS 9 TERMINAL 29 | | | | UNCENSORED DEATHS | | 365 427 584 606 635 641 641 643 659 662 | | 670 673 677 684 686 686 687 694 700 707 | | 707 721 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 | | | ================================================================================== CODEINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1600 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 19 CENSORED DEATHS 9 TERMINAL 32 | | | | UNCENSORED DEATHS | | 383 444 473 617 624 631 638 645 664 684 | | 691 698 701 702 714 718 719 720 725 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 | | | ================================================================================== CODEINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 733 (A) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 100.0 100.0 100.0 98.3 98.3 92.6 86.6 70.5 66.5 56.4 | | | | | | | |400 PPM | 100.0 100.0 100.0 100.0 98.3 96.3 94.3 92.3 90.3 76.3 | | | | | | | |800 PPM | 100.0 100.0 100.0 98.3 98.3 96.7 96.7 94.7 80.9 57.2 | | | | | | | |1600 PPM| 100.0 100.0 100.0 100.0 98.3 94.7 94.7 94.7 82.9 63.1 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 400 PPM 800 PPM 1600 P|M | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 56.4% 76.3% 57.2% 63.1% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.782N P=0.035N P=0.718N P=0.369N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 571.7 623.8 643.4 641.6 | |NATURAL DEATHS (C) | (21.4) (31.3) (18.6) (23.0) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 627.7 665.0 658.6 662.5 | |(STANDARD ERROR) | (15.8) (14.7) (14.0) (14.4) | | | | ================================================================================== (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) CODEINE KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 400 PPM = 2 800 PPM = 3 1600 PPM = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 2 4 3 | 1 1 4 4 2 2 1 4 33 | 2 1 1 4 3 32 | 1 11 44 23 2 P 90 + 1 1 44 332 2 2 E | 1 44133 22 R | 41133 3 C | 414 132 23 E 80 + 4 4 1 21 N | 4 4 11 T | 4 4 121 | 4 4 3 3 S 70 + 4 21 11 U | 2 4121 R | 3 3 3 V | 4 1 1 I 60 + 2231 1 1 V | 2233 A | 2233 L | 2233 50 + 44 | 2233 4 | 22 | 23 2 40 + 2 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 40 obs hidden. CODEINE KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 400 PPM = 2 800 PPM = 3 1600 PPM = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 3 4 2 | 1 3 4 2 31 4 2 | | 31 4 12 2 3 95 + 4 3 3 4 | | 1 1 2 2 443 | 11 433 90 + 2 2 | 1 1 44 22 P | E | 1 1 44 R 85 + 34 3 C | 2 2 E | 1 1 4 4 N | 33 44 T 80 + 22 | 33 44 2 2 S | 44 U | 11 2 R 75 + 33 V | I | 1 1 44 V | 44 A 70 + 1 1 L | 1 1 33 | 33 | 1 1 65 + 44 | 33 4 4 | 1 1 | 60 + 1 1 | 3131 | 3 3 | 1 1 55 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 7 obs hidden.