TDMS Study 05122-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: LITRI NICKEL SULFATE HEXAHYDRATE DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 TIME: 03:19:35 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: Y01-ES-30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C60344 PATHOLOGIST: K. NIKULA CAS: 010101970 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: LITRI NICKEL SULFATE HEXAHYDRATE DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 TIME: 03:19:35 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: Y01-ES-30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C60344 PATHOLOGIST: K. NIKULA CAS: 010101970 NICKEL SULFATE HEXAHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.0MG/M3 | | --------------------- | | | | TOTAL 59 UNCENSORED DEATHS 38 CENSORED DEATHS 5 TERMINAL 16 | | | | UNCENSORED DEATHS | | 117 262 482 496 505 518 536 539 539 550 | | 565 569 577 597 610 614 618 622 622 626 | | 634 637 655 657 657 658 662 679 679 686 | | 693 703 703 708 720 721 726 731 | | CENSORED DEATHS | | 458 458 458 458 458 | | | |--------------------------------------------------------------------------------| | DOSE = 0.0MG/M3LUNG TOX | | ---------------------------- | | | | TOTAL 11 UNCENSORED DEATHS 0 CENSORED DEATHS 11 TERMINAL 0 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | 199 199 199 199 199 199 199 199 199 199 | | 199 | | | |--------------------------------------------------------------------------------| | DOSE = 0.12 MG/M3 | | ---------------------------- | | | | TOTAL 58 UNCENSORED DEATHS 37 CENSORED DEATHS 5 TERMINAL 16 | | | | UNCENSORED DEATHS | | 352 363 539 547 551 566 566 570 580 598 | | 600 607 615 632 640 640 643 644 646 650 | | 658 675 679 682 683 683 685 692 702 703 | | 704 708 720 720 726 726 732 | | CENSORED DEATHS | | 458 458 458 458 458 | | | ================================================================================== NICKEL SULFATE HEXAHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.12MGM3LUNG TOX | | ---------------------------- | | | | TOTAL 12 UNCENSORED DEATHS 0 CENSORED DEATHS 12 TERMINAL 0 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | 199 199 199 199 199 199 199 199 199 199 | | 199 199 | | | |--------------------------------------------------------------------------------| | DOSE = 0.25 MG/M3 | | ---------------------------- | | | | TOTAL 58 UNCENSORED DEATHS 34 CENSORED DEATHS 6 TERMINAL 18 | | | | UNCENSORED DEATHS | | 279 432 471 492 535 535 538 550 551 551 | | 576 597 597 601 606 607 614 617 621 628 | | 643 651 679 683 684 685 697 706 711 713 | | 725 726 727 732 | | CENSORED DEATHS | | 458 458 458 458 458 717 | | | |--------------------------------------------------------------------------------| | DOSE = 0.25MGM3LUNG TOX | | ---------------------------- | | | | TOTAL 12 UNCENSORED DEATHS 0 CENSORED DEATHS 12 TERMINAL 0 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | 199 199 199 199 199 199 199 199 199 199 | | 199 199 | | | ================================================================================== NICKEL SULFATE HEXAHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.5MG/M3 | | --------------------- | | | | TOTAL 58 UNCENSORED DEATHS 32 CENSORED DEATHS 5 TERMINAL 21 | | | | UNCENSORED DEATHS | | 320 419 420 433 460 539 552 563 576 583 | | 584 584 602 628 628 628 629 630 634 638 | | 640 651 654 671 676 688 688 697 697 699 | | 713 726 | | CENSORED DEATHS | | 458 458 458 458 458 | | | |--------------------------------------------------------------------------------| | DOSE = 0.5MG/M3LUNG TOX | | ---------------------------- | | | | TOTAL 12 UNCENSORED DEATHS 0 CENSORED DEATHS 12 TERMINAL 0 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | 199 199 199 199 199 199 199 199 199 199 | | 199 199 | | | ================================================================================== NICKEL SULFATE HEXAHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE 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) | | | |--------------------------------------------------------------------------------| | | | |0.0MG/M3 | 100.0 98.3 96.6 96.6 96.6 94.8 83.6 74.3 50.2 29.7 | | | | | | | |0.0MG/M3LUN| 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 | |TOX | | | | | |0.12 | 100.0 100.0 100.0 96.6 96.6 96.6 94.7 79.5 60.6 30.3 | |MG/M3 | | | | | |0.12MGM3LUN| 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 | |TOX | | | | | |0.25 | 100.0 100.0 100.0 98.3 98.3 94.7 87.1 73.8 58.7 35.6 | |MG/M3 | | | | | |0.25MGM3LUN| 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 | |TOX | | | | | |0.5MG/M3 | 100.0 100.0 100.0 98.3 94.8 91.2 89.3 76.0 57.0 39.9 | | | | | | | |0.5MG/M3LUN| 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 | |TOX | | | | | ================================================================================== NICKEL SULFATE HEXAHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0.0MG/M3 0.0MG/M3LUNG0.12 0.12MGM3LUNG0.25 0.25MGM3LUNG0.5MG/M3 0.5MG/M3L|NG | TOX MG/M3 TOX MG/M3 TOX TOX | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 29.7% 0.0% 30.3% 0.0% 35.6% 0.0% 39.9% 0.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.373N ----- P=0.730N P=1.000N P=0.597N P=1.000N P=0.417N P=1.000N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 601.9 . 633.2 . 610.6 . 601.6 . | |NATURAL DEATHS (C) | (19.8) ( . ) (14.4) ( . ) (16.9) ( . ) (17.3) ( . ) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 625.3 199.0 645.6 199.0 637.3 199.0 636.8 199.0 | |(STANDARD ERROR) | (16.2) ( 0.0) (13.2) ( 0.0) (14.3) ( 0.0) (14.5) ( 0.0) | | | | =============================================================================================================================== (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) NICKEL SULFATE HEXAHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.0MG/M3 | | --------------------- | | | | TOTAL 58 UNCENSORED DEATHS 31 CENSORED DEATHS 5 TERMINAL 22 | | | | UNCENSORED DEATHS | | 446 503 536 538 542 566 584 589 621 622 | | 640 643 643 643 643 658 663 666 669 677 | | 683 686 688 690 691 692 696 713 714 721 | | 727 | | CENSORED DEATHS | | 459 459 459 459 459 | | | |--------------------------------------------------------------------------------| | DOSE = 0.0MG/M3LUNG TOX | | ---------------------------- | | | | TOTAL 12 UNCENSORED DEATHS 0 CENSORED DEATHS 12 TERMINAL 0 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | 200 200 200 200 200 200 200 200 200 200 | | 200 200 | | | |--------------------------------------------------------------------------------| | DOSE = 0.12 MG/M3 | | ---------------------------- | | | | TOTAL 58 UNCENSORED DEATHS 36 CENSORED DEATHS 5 TERMINAL 17 | | | | UNCENSORED DEATHS | | 392 489 537 537 539 550 559 559 573 580 | | 592 596 596 600 605 607 619 620 627 636 | | 643 644 644 644 653 656 657 658 664 664 | | 676 678 682 691 706 725 | | CENSORED DEATHS | | 459 459 459 459 459 | | | ================================================================================== NICKEL SULFATE HEXAHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.12MGM3LUNG TOX | | ---------------------------- | | | | TOTAL 12 UNCENSORED DEATHS 0 CENSORED DEATHS 12 TERMINAL 0 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | 200 200 200 200 200 200 200 200 200 200 | | 200 200 | | | |--------------------------------------------------------------------------------| | DOSE = 0.25 MG/M3 | | ---------------------------- | | | | TOTAL 58 UNCENSORED DEATHS 25 CENSORED DEATHS 5 TERMINAL 28 | | | | UNCENSORED DEATHS | | 403 510 605 608 617 629 629 642 647 648 | | 648 655 661 662 662 662 675 675 683 697 | | 700 706 710 711 715 | | CENSORED DEATHS | | 459 459 459 459 459 | | | |--------------------------------------------------------------------------------| | DOSE = 0.25MGM3LUNG TOX | | ---------------------------- | | | | TOTAL 11 UNCENSORED DEATHS 0 CENSORED DEATHS 11 TERMINAL 0 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | 200 200 200 200 200 200 200 200 200 200 | | 200 | | | ================================================================================== NICKEL SULFATE HEXAHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.5MG/M3 | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 24 CENSORED DEATHS 7 TERMINAL 29 | | | | UNCENSORED DEATHS | | 28 119 272 370 432 475 480 497 527 538 | | 538 538 541 568 637 648 654 661 662 681 | | 685 688 697 702 | | CENSORED DEATHS | | 190 323 459 459 459 459 459 | | | |--------------------------------------------------------------------------------| | DOSE = 0.5MG/M3LUNG TOX | | ---------------------------- | | | | TOTAL 10 UNCENSORED DEATHS 0 CENSORED DEATHS 10 TERMINAL 0 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | 200 200 200 200 200 200 200 200 200 200 | | | ================================================================================== NICKEL SULFATE HEXAHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE 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) | | | |--------------------------------------------------------------------------------| | | | |0.0MG/M3 | 100.0 100.0 100.0 100.0 100.0 98.3 90.7 85.0 68.0 41.6 | | | | | | | |0.0MG/M3LUN| 100.0 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 | |TOX | | | | | |0.12 | 100.0 100.0 100.0 100.0 98.3 98.3 90.7 71.8 43.5 32.1 | |MG/M3 | | | | | |0.12MGM3LUN| 100.0 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 | |TOX | | | | | |0.25 | 100.0 100.0 100.0 100.0 98.3 98.3 96.4 94.5 69.9 52.9 | |MG/M3 | | | | | |0.25MGM3LUN| 100.0 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 | |TOX | | | | | |0.5MG/M3 | 98.3 96.7 96.7 95.0 93.2 87.7 76.3 74.4 64.8 55.3 | | | | | | | |0.5MG/M3LUN| 100.0 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 | |TOX | | | | | ================================================================================== NICKEL SULFATE HEXAHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0.0MG/M3 0.0MG/M3LUNG0.12 0.12MGM3LUNG0.25 0.25MGM3LUNG0.5MG/M3 0.5MG/M3L|NG | TOX MG/M3 TOX MG/M3 TOX TOX | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 41.6% 0.0% 32.1% 0.0% 52.9% 0.0% 55.3% 0.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.157N ----- P=0.160 ----- P=0.299N ----- P=0.509N ----- | |(LIFE TABLE) | | | | | |MEAN DAY OF | 638.5 . 613.8 . 646.4 . 526.6 . | |NATURAL DEATHS (C) | (12.5) ( . ) (11.0) ( . ) (13.4) ( . ) (36.5) ( . ) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 657.3 200.0 634.2 200.0 670.1 200.0 609.8 200.0 | |(STANDARD ERROR) | (11.9) ( 0.0) (12.0) ( 0.0) (11.6) ( 0.0) (21.8) ( 0.0) | | | | =============================================================================================================================== (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) NICKEL SULFATE HEXAHYDRATE KAPLAN-MEIER SURVIVAL CURVES 0.0MG/M3 = 1 0.0MG/M3LUNG TOX = 2 0.12 MG/M3 = 3 0.12MGM3LUNG TOX = 4 0.25 MG/M3 = 5 0.25MGM3LUNG TOX = 6 0.5MG/M3 = 7 0.5MG/M3LUNG TOX = 8 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 1 5 7 33 7 5 | 1 3 7 5 7 51 1 1 3 3 P | 7 11 1 3 3 E | 1 1 3337 3 R 80 + 1 1117 333 C | 1 151 733 E | 511 N | 11133 T 60 + 51531 3 | 7 7337 S | 1 1 13355 U | 111715 5 R 40 + 1135 5 V | 111 5 I | 1 1 V | A 20 + L | | | 0 + 2 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 104 obs hidden. NICKEL SULFATE HEXAHYDRATE KAPLAN-MEIER SURVIVAL CURVES 0.0MG/M3 = 1 0.0MG/M3LUNG TOX = 2 0.12 MG/M3 = 3 0.12MGM3LUNG TOX = 4 0.25 MG/M3 = 5 0.25MGM3LUNG TOX = 6 0.5MG/M3 = 7 0.5MG/M3LUNG TOX = 8 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 7 7 2 3 5 1 3 15 | 7 7 7 7 3 15 11 5 5 P | 7 77 7 31331 1 55 E | 7 77 3 331 1 15 55 R 80 + 77 3 33 1 155 C | 7 7 33 7 5 5 E | 3 3 7171 115 N | 333 7115 5 T 60 + 33 111555 | 3 3 7755 5 S | 11 1 U | 3 3 3 111 R 40 + 333 1 1 V | 3 3 3 I | 3 3 V | A 20 + L | | | 0 + 2 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 57 obs hidden.