TDMS Study 05102-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus BENZETHONIUM CHLORIDE DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 TIME: 18:22:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75177 ROUTE: DERMAL,SOLUTION NTP C#: 61494B PATHOLOGIST: R. PERSING S. EUSTIS CAS: 121-54-0 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus BENZETHONIUM CHLORIDE DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 TIME: 18:22:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75177 ROUTE: DERMAL,SOLUTION NTP C#: 61494B PATHOLOGIST: R. PERSING S. EUSTIS CAS: 121-54-0 BENZETHONIUM CHLORIDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 37 CENSORED DEATHS 8 TERMINAL 15 | | | | UNCENSORED DEATHS | | 406 437 513 533 549 551 556 564 583 585 | | 592 603 606 606 606 612 632 634 635 647 | | 647 648 650 653 653 655 659 679 689 691 | | 691 709 709 714 716 716 726 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = .15MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 41 CENSORED DEATHS 8 TERMINAL 11 | | | | UNCENSORED DEATHS | | 264 379 457 461 479 499 541 542 556 556 | | 564 576 578 579 591 593 606 610 612 612 | | 616 620 621 623 626 632 638 639 659 659 | | 668 670 671 675 691 698 698 710 712 722 | | 723 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 0.5MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 45 CENSORED DEATHS 6 TERMINAL 9 | | | | UNCENSORED DEATHS | | 199 367 416 437 483 500 505 511 523 526 | | 537 556 575 587 589 599 601 613 613 621 | | 626 632 632 635 635 643 648 649 655 658 | | 658 662 663 664 666 671 676 682 683 696 | | 698 707 712 718 727 | | CENSORED DEATHS | | 25 456 456 456 456 456 | | | ================================================================================== BENZETHONIUM CHLORIDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1.5MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 40 CENSORED DEATHS 4 TERMINAL 16 | | | | UNCENSORED DEATHS | | 170 291 364 396 408 425 465 533 537 549 | | 551 556 557 562 594 605 609 613 613 619 | | 626 635 639 639 643 644 649 655 659 660 | | 662 675 679 683 691 692 710 710 722 722 | | CENSORED DEATHS | | 456 456 456 456 | | | ================================================================================== BENZETHONIUM CHLORIDE 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) | | | |--------------------------------------------------------------------------------| | | | |0MG/KG | 100.0 100.0 100.0 100.0 98.3 96.7 92.8 77.3 48.3 29.0 | | | | | | | |.15MG/KG | 100.0 100.0 98.3 98.3 96.7 90.9 85.1 69.6 42.5 21.3 | | | | | | | |0.5MG/KG | 100.0 100.0 98.3 98.3 94.9 91.4 80.2 69.0 37.3 16.8 | | | | | | | |1.5MG/KG | 100.0 98.3 98.3 95.0 90.0 88.2 84.6 72.0 45.0 28.8 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 29.0% 21.3% 16.8% 28.8% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.892N P=0.286 P=0.129 P=0.802 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 623.1 600.6 601.2 585.3 | |NATURAL DEATHS (C) | (12.3) (14.7) (15.4) (19.4) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 627.3 604.9 598.7 615.0 | |(STANDARD ERROR) | (12.9) (14.1) (17.3) (16.2) | | | | ================================================================================== (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) BENZETHONIUM CHLORIDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 27 CENSORED DEATHS 9 TERMINAL 24 | | | | UNCENSORED DEATHS | | 176 485 515 519 526 554 572 595 603 610 | | 612 633 642 642 644 645 648 649 667 696 | | 709 718 719 720 722 724 724 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = .15MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 20 CENSORED DEATHS 7 TERMINAL 33 | | | | UNCENSORED DEATHS | | 366 393 456 519 530 538 551 582 602 612 | | 612 633 638 659 677 680 684 696 710 727 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 0.5MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 25 CENSORED DEATHS 9 TERMINAL 26 | | | | UNCENSORED DEATHS | | 297 465 492 533 549 565 578 579 579 581 | | 606 610 632 668 678 679 685 686 694 698 | | 704 708 712 720 725 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 | | | ================================================================================== BENZETHONIUM CHLORIDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1.5MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 29 CENSORED DEATHS 7 TERMINAL 24 | | | | UNCENSORED DEATHS | | 303 322 358 486 525 533 537 562 576 587 | | 587 594 603 613 619 632 634 634 636 640 | | 647 658 667 668 677 680 699 700 723 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 | | | ================================================================================== BENZETHONIUM CHLORIDE 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) | | | |--------------------------------------------------------------------------------| | | | |0MG/KG | 100.0 98.3 98.3 98.3 98.3 96.4 90.5 82.6 64.9 47.2 | | | | | | | |.15MG/KG | 100.0 100.0 100.0 100.0 96.7 95.0 89.3 83.6 74.1 62.7 | | | | | | | |0.5MG/KG | 100.0 100.0 100.0 98.3 98.3 96.4 92.4 80.6 74.7 51.1 | | | | | | | |1.5MG/KG | 100.0 100.0 100.0 95.0 95.0 95.0 87.4 76.0 58.9 45.6 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 47.2% 62.7% 51.1% 45.6% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.256 P=0.232N P=0.854N P=0.728 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 617.4 593.3 616.9 589.7 | |NATURAL DEATHS (C) | (21.8) (22.9) (20.0) (19.8) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 637.8 651.9 641.4 629.8 | |(STANDARD ERROR) | (15.4) (14.4) (14.7) (15.2) | | | | ================================================================================== (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) BENZETHONIUM CHLORIDE KAPLAN-MEIER SURVIVAL CURVES 0MG/KG = 1 .15MG/KG = 2 0.5MG/KG = 3 1.5MG/KG = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 3 2 1 | 4 3 2 4 43 2 1 3 1 2 1 | 4 4 3 3 1 1 | 4 4 4 3 2 2 3 1 1 90 + 4 4 2 23 211 | 4 4 11 | 3 3342421 1 | 33 80 + 3 422 21 1 1 | 34 33 P | 4 3 3 4 E | 2 2311 R 70 + 2321 1 C | 224 E | 3341 1 N | 333 T 60 + 22 44 | S | 223311 U | 22334 R 50 + 22 1 1 V | 233 1 1 1 I | 4 4 V | 3 2244 A 40 + 41 1 L | 322 | 2 2 11 | 33322 4 4 30 + 2 211 1 | 3 3 | 332 2 | 33 2 2 20 + 33 | 33 3 | | 10 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 47 obs hidden. BENZETHONIUM CHLORIDE KAPLAN-MEIER SURVIVAL CURVES 0MG/KG = 1 .15MG/KG = 2 0.5MG/KG = 3 1.5MG/KG = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 34 2 | 1 34 4 42 2 23 13 1 | 4 2 43 1 1 3 | 4 113 3 P 90 + 412 213 E | 4 213132 1 R | 4 42 121 C | 44 211 E 80 + 34 4 32 2 N | 4 31 11 T | 444 32 232 | 4 4 322 S 70 + 11 33 U | 2 2 2 R | 441 1 3 3 2 2 V | 44 1 1 2 2 I 60 + 44 4 1311 V | A | 44 33 L | 44 4 11 50 + 3 3 | 4 1 1 | 4 4 | 40 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 38 obs hidden.