TDMS Study 05092-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst DATE: 09/12/94 EXP: 05092 O-NITROANISOLE TIME: 16:31:13 TEST: 01 CAGES FROM 0000 TO LAST CAGE PAGE: 1 TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: C60388 CONT: N01-ES-45038 CAS: 0091-23-6 PATHOLOGIST: R. THOMPSON S. EUSTIS -------------------------------------------------------------------------------- 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: 09/12/94 EXP: 05092 O-NITROANISOLE TIME: 16:31:13 TEST: 01 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: C60388 CONT: N01-ES-45038 CAS: 0091-23-6 PATHOLOGIST: R. THOMPSON S. EUSTIS O-NITROANISOLE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.0% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 0 TERMINAL 32 | | | | UNCENSORED DEATHS | | 484 496 575 599 603 613 617 633 668 669 | | 669 669 673 676 683 695 696 716 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.0% 15 SSAC | | ---------------------------- | | | | TOTAL 10 UNCENSORED DEATHS 0 CENSORED DEATHS 10 TERMINAL 0 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | 456 456 456 457 457 457 457 458 458 458 | | | |--------------------------------------------------------------------------------| | DOSE = 0.0222% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 0 TERMINAL 34 | | | | UNCENSORED DEATHS | | 63 423 511 551 559 589 638 641 642 647 | | 647 655 681 682 687 719 | | CENSORED DEATHS | | NONE | | | ================================================================================== O-NITROANISOLE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.0222% 15 SSAC | | ---------------------------- | | | | TOTAL 10 UNCENSORED DEATHS 0 CENSORED DEATHS 10 TERMINAL 0 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | 456 456 456 457 457 457 458 458 458 458 | | | |--------------------------------------------------------------------------------| | DOSE = 0.0666% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 26 CENSORED DEATHS 0 TERMINAL 24 | | | | UNCENSORED DEATHS | | 437 533 557 558 596 604 632 637 641 646 | | 646 647 657 667 667 667 669 679 683 686 | | 687 695 716 718 722 722 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.0666% 15 SSAC | | ---------------------------- | | | | TOTAL 10 UNCENSORED DEATHS 0 CENSORED DEATHS 10 TERMINAL 0 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | 456 456 456 457 457 457 458 458 458 458 | | | ================================================================================== O-NITROANISOLE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.200% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 41 CENSORED DEATHS 0 TERMINAL 9 | | | | UNCENSORED DEATHS | | 481 491 502 511 518 518 529 554 561 563 | | 589 589 589 604 604 613 621 632 632 632 | | 632 633 641 642 646 646 655 655 658 663 | | 667 669 686 686 687 687 695 697 697 699 | | 715 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.200% 15 SSAC | | ---------------------------- | | | | TOTAL 10 UNCENSORED DEATHS 1 CENSORED DEATHS 9 TERMINAL 0 | | | | UNCENSORED DEATHS | | 106 | | CENSORED DEATHS | | 456 456 456 456 457 457 457 458 458 | | | ================================================================================== O-NITROANISOLE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 728 (A) | | | |--------------------------------------------------------------------------------| | | | |0.0% | 100.0 100.0 100.0 100.0 100.0 98.0 96.0 90.0 84.0 64.0 | | | | | | | |0.0% | 100.0 100.0 100.0 100.0 100.0 0.0 0.0 0.0 0.0 0.0 | |15 SSAC | | | | | |0.0222% | 98.0 98.0 98.0 98.0 96.0 96.0 94.0 88.0 76.0 68.0 | | | | | | | |0.0222% | 100.0 100.0 100.0 100.0 100.0 0.0 0.0 0.0 0.0 0.0 | |15 SSAC | | | | | |0.0666% | 100.0 100.0 100.0 100.0 100.0 98.0 96.0 88.0 74.0 48.0 | | | | | | | |0.0666% | 100.0 100.0 100.0 100.0 100.0 0.0 0.0 0.0 0.0 0.0 | |15 SSAC | | | | | |0.200% | 100.0 100.0 100.0 100.0 100.0 98.0 86.0 70.0 40.0 18.0 | | | | | | | |0.200% | 100.0 90.0 90.0 90.0 90.0 0.0 0.0 0.0 0.0 0.0 | |15 SSAC | | | | | ================================================================================== O-NITROANISOLE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 0.200% 0.200% | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 64.0% 0.0% 68.0% 0.0% 48.0% 0.0% 18.0% 0.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 ----- P=0.893N ----- P=0.172 ----- P<0.001 P=0.371 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 635.2 . 583.4 . 645.0 . 619.2 106.0 | |NATURAL DEATHS (C) | (15.4) ( . ) (39.5) ( . ) (12.9) ( . ) (10.2) ( . ) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 694.6 457.0 681.7 457.1 684.8 457.1 638.8 421.7 | |(STANDARD ERROR) | ( 8.4) ( 0.3) (15.7) ( 0.3) ( 8.9) ( 0.3) (10.2) (35.1) | | | | =============================================================================================================================== (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) O-NITROANISOLE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.0% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 438 480 494 518 613 613 634 663 669 673 | | 687 687 694 700 700 700 723 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.0% 15 SSAC | | ---------------------------- | | | | TOTAL 10 UNCENSORED DEATHS 0 CENSORED DEATHS 10 TERMINAL 0 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | 456 456 456 457 457 457 458 458 458 458 | | | |--------------------------------------------------------------------------------| | DOSE = 0.0222% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 9 CENSORED DEATHS 0 TERMINAL 41 | | | | UNCENSORED DEATHS | | 333 436 533 598 646 672 723 727 727 | | CENSORED DEATHS | | NONE | | | ================================================================================== O-NITROANISOLE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.0222% 15 SSAC | | ---------------------------- | | | | TOTAL 10 UNCENSORED DEATHS 0 CENSORED DEATHS 10 TERMINAL 0 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | 456 456 456 457 457 457 457 458 458 458 | | | |--------------------------------------------------------------------------------| | DOSE = 0.0666% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 24 CENSORED DEATHS 0 TERMINAL 26 | | | | UNCENSORED DEATHS | | 302 416 459 525 533 536 563 571 571 589 | | 610 613 630 632 633 641 646 658 683 683 | | 695 710 716 719 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.0666% 15 SSAC | | ---------------------------- | | | | TOTAL 10 UNCENSORED DEATHS 0 CENSORED DEATHS 10 TERMINAL 0 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | 456 456 456 456 457 457 457 457 458 458 | | | ================================================================================== O-NITROANISOLE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.200% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 386 476 500 521 557 604 604 613 631 634 | | 647 655 663 687 716 720 722 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.200% 15 SSAC | | ---------------------------- | | | | TOTAL 10 UNCENSORED DEATHS 1 CENSORED DEATHS 9 TERMINAL 0 | | | | UNCENSORED DEATHS | | 407 | | CENSORED DEATHS | | 456 456 456 457 457 458 458 458 458 | | | ================================================================================== O-NITROANISOLE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 728 (A) | | | |--------------------------------------------------------------------------------| | | | |0.0% | 100.0 100.0 100.0 100.0 100.0 96.0 92.0 92.0 84.0 66.0 | | | | | | | |0.0% | 100.0 100.0 100.0 100.0 100.0 0.0 0.0 0.0 0.0 0.0 | |15 SSAC | | | | | |0.0222% | 100.0 100.0 100.0 98.0 98.0 96.0 94.0 92.0 90.0 82.0 | | | | | | | |0.0222% | 100.0 100.0 100.0 100.0 100.0 0.0 0.0 0.0 0.0 0.0 | |15 SSAC | | | | | |0.0666% | 100.0 100.0 100.0 98.0 96.0 94.0 88.0 80.0 64.0 52.0 | | | | | | | |0.0666% | 100.0 100.0 100.0 100.0 100.0 0.0 0.0 0.0 0.0 0.0 | |15 SSAC | | | | | |0.200% | 100.0 100.0 100.0 100.0 98.0 96.0 92.0 86.0 74.0 66.0 | | | | | | | |0.200% | 100.0 100.0 100.0 100.0 90.0 0.0 0.0 0.0 0.0 0.0 | |15 SSAC | | | | | ================================================================================== O-NITROANISOLE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 0.200% 0.200% | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 66.0% 0.0% 82.0% 0.0% 52.0% 0.0% 66.0% 0.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.385 ----- P=0.108N P=1.000N P=0.149 P=1.000N P=1.000 P=0.727 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 628.6 . 599.4 . 597.3 . 608.0 407.0 | |NATURAL DEATHS (C) | (21.8) ( . ) (46.8) ( . ) (20.5) ( . ) (22.7) ( . ) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 694.2 457.1 704.9 457.0 665.2 456.8 687.2 452.1 | |(STANDARD ERROR) | ( 9.9) ( 0.3) (10.7) ( 0.3) (13.5) ( 0.2) (11.1) ( 5.0) | | | | =============================================================================================================================== (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) O-NITROANISOLE KAPLAN-MEIER SURVIVAL CURVES 0.0% = 1 0.0% 15 SSAC = 2 0.0222% = 3 0.0222% 15 SSAC = 4 0.0666% = 5 0.0666% 15 SSAC = 6 0.200% = 7 0.200% 15 SSAC = 8 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 3 8 3 5 211 5 | 3 173 5 35 1 1 P | 8 8 77 7 33 31111 53 E | 7 77 1 15 1 R 80 + 7 7 333 C | 7 7 53 113 E | 777 1131 33 N | 7 7 555 1 11 T 60 + 555 | 77 5 5 S | 777 55 U | R 40 + 7 77 V | 7 7 I | 777 V | A 20 + 7 77 L | | | 0 + 2 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 55 obs hidden. O-NITROANISOLE KAPLAN-MEIER SURVIVAL CURVES 0.0% = 1 0.0% 15 SSAC = 2 0.0222% = 3 0.0222% 15 SSAC = 4 0.0666% = 5 0.0666% 15 SSAC = 6 0.200% = 7 0.200% 15 SSAC = 8 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 5 3 7 85 1 2 71 | 5 3 5 71 17 1 5 3 3 P | 8 8 1 5 5 75 371 1 3 3 3 E | 55 77 1 11 R 80 + 5 5 5 7 77 11 1 3 C | 5 55 7 7 11 E | 555 71 71 N | 55 5 1 T 60 + 5 5 5 | 55 S | 55 U | R 40 + V | I | V | A 20 + L | | | 0 + 2 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 43 obs hidden.