TDMS Study 88007-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus SODIUM NITRITE DATE: 10/18/99 EXPERIMENT: 88007 TEST: 05 TIME: 14:02:25 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-55384 ROUTE: DOSED WATER NTP C#: C88007 PATHOLOGIST: YARRINGTON, JOHN CAS: 7632-00-0 ------------------------------------------------------------------------------------------------------------------------------------ FINAL #1 CORE STUDY RATS REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus SODIUM NITRITE DATE: 10/18/99 EXPERIMENT: 88007 TEST: 05 TIME: 14:02:25 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55384 ROUTE: DOSED WATER NTP C#: C88007 PATHOLOGIST: YARRINGTON, JOHN CAS: 7632-00-0 SODIUM NITRITE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.0% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 21 CENSORED DEATHS 0 TERMINAL 29 | | | | UNCENSORED DEATHS | | 252 400 486 489 523 529 558 573 589 589 | | 605 610 620 624 631 636 648 666 680 683 | | 724 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.075% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 0 TERMINAL 38 | | | | UNCENSORED DEATHS | | 415 480 481 552 582 601 641 646 669 680 | | 691 693 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.15% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 400 505 551 582 593 620 680 694 695 697 | | 708 716 724 728 | | CENSORED DEATHS | | NONE | | | ================================================================================== SODIUM NITRITE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.30% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 520 523 551 589 605 622 636 638 655 697 | | 698 705 710 715 | | CENSORED DEATHS | | NONE | | | ================================================================================== SODIUM NITRITE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS 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) | | | |--------------------------------------------------------------------------------| | | | |0.0% | 100.0 100.0 98.0 98.0 96.0 96.0 88.0 78.0 66.0 58.0 | | | | | | | |0.075% | 100.0 100.0 100.0 100.0 98.0 94.0 94.0 88.0 84.0 76.0 | | | | | | | |0.15% | 100.0 100.0 100.0 100.0 98.0 98.0 96.0 90.0 88.0 72.0 | | | | | | | |0.30% | 100.0 100.0 100.0 100.0 100.0 100.0 96.0 90.0 82.0 72.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0.0% 0.075% 0.15% 0.30% | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 58.0% 76.0% 72.0% 72.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.215N P=0.075N P=0.128N P=0.137N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 576.9 594.3 635.2 633.1 | |NATURAL DEATHS (C) | (23.3) (27.1) (26.2) (18.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 665.1 696.7 702.7 702.2 | |(STANDARD ERROR) | (14.4) (10.4) ( 9.3) ( 7.9) | | | | ================================================================================== (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) SODIUM NITRITE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.0% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 511 513 547 548 567 596 601 644 648 661 | | 662 669 669 693 694 714 729 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.075% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 0 TERMINAL 31 | | | | UNCENSORED DEATHS | | 332 480 536 541 609 616 648 651 662 665 | | 676 680 685 690 696 706 718 723 728 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.15% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 337 541 541 554 596 624 626 638 658 668 | | 687 696 723 727 | | CENSORED DEATHS | | NONE | | | ================================================================================== SODIUM NITRITE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.30% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 361 465 474 513 624 626 627 629 658 680 | | 680 694 704 715 718 723 723 | | CENSORED DEATHS | | NONE | | | ================================================================================== SODIUM NITRITE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS 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) | | | |--------------------------------------------------------------------------------| | | | |0.0% | 100.0 100.0 100.0 100.0 100.0 100.0 96.0 86.0 78.0 66.0 | | | | | | | |0.075% | 100.0 100.0 100.0 98.0 98.0 96.0 92.0 92.0 80.0 62.0 | | | | | | | |0.15% | 100.0 100.0 100.0 98.0 98.0 98.0 94.0 90.0 82.0 72.0 | | | | | | | |0.30% | 100.0 100.0 100.0 98.0 98.0 94.0 92.0 92.0 82.0 66.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0.0% 0.075% 0.15% 0.30% | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 66.0% 62.0% 72.0% 66.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.853N P=0.890 P=0.657N P=1.000N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 627.4 633.8 615.4 624.4 | |NATURAL DEATHS (C) | (16.9) (22.9) (27.1) (26.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 695.1 693.4 697.9 694.1 | |(STANDARD ERROR) | ( 8.9) (10.8) (10.4) (11.2) | | | | ================================================================================== (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) SODIUM NITRITE KAPLAN-MEIER SURVIVAL CURVES 0.0% = 1 0.075% = 2 0.15% = 3 0.30% = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 3 2 4 | | 1 1 2 2 3 | 1 1 3 4 3 95 + | 2 2 3 4 | 1 1 2 2 3 4 | 90 + 11 2 324 3 | P | 1 1 2 3 42 3 E | 1 1 422 3 3 R 85 + C | 1 1 424 2 E | 4 2 2 4 N | T 80 + 1 1 223 3 | S | 11 4433 U | 11 2 4433 2 R 75 + V | 11 44 I | 11 43 3 V | A 70 + L | | 1 1 | 1 1 65 + | 1 1 | | 60 + 1 1 | | 1 1 | 55 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 13 obs hidden. SODIUM NITRITE KAPLAN-MEIER SURVIVAL CURVES 0.0% = 1 0.075% = 2 0.15% = 3 0.30% = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 23 4 1 | | 23 4 4 2 11 3 | 442 1 2 1 95 + | 4 4 22 3 | 4 2131 32 4 | P 90 + 1 122 3 E | R | 2 2 C | 1 3 1 E 85 + N | 4 113 2 T | 13 13 4 | S 80 + 232 3 U | R | 112233 V | 34 3 I 75 + V | 1 21 4 4 A | 11 3 3 L | 70 + 12144 | | 212 1 | 22 1 65 + | | 2 2 | 60 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 19 obs hidden.