TDMS Study 05099-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst SALICYLAZOSULFAPYRIDINE DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 TIME: 19:39:42 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85233 ROUTE: GAVAGE NTP C#: 61552B PATHOLOGIST: DR J. HEATH CAS: 599-79-1 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst SALICYLAZOSULFAPYRIDINE DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 TIME: 19:39:42 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85233 ROUTE: GAVAGE NTP C#: 61552B PATHOLOGIST: DR J. HEATH CAS: 599-79-1 SALICYLAZOSULFAPYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 14 CENSORED DEATHS 21 TERMINAL 35 | | | | UNCENSORED DEATHS | | 473 477 500 523 551 605 632 653 676 684 | | 708 717 717 726 | | CENSORED DEATHS | | 150 183 183 183 183 183 183 183 183 183 | | 183 456 456 456 456 456 457 457 457 457 | | 457 | | | |--------------------------------------------------------------------------------| | DOSE = 0 MG/KG FEED RTD | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 17 CENSORED DEATHS 12 TERMINAL 31 | | | | UNCENSORED DEATHS | | 484 521 526 542 578 591 620 627 646 689 | | 689 692 697 703 704 709 726 | | CENSORED DEATHS | | 66 456 456 456 456 456 457 457 457 457 | | 457 458 | | | |--------------------------------------------------------------------------------| | DOSE = 84 MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 13 CENSORED DEATHS 14 TERMINAL 33 | | | | UNCENSORED DEATHS | | 414 424 515 605 625 654 659 662 680 691 | | 692 709 726 | | CENSORED DEATHS | | 85 234 243 456 456 456 456 456 457 457 | | 457 457 457 460 | | | ================================================================================== SALICYLAZOSULFAPYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 168 MG/KG | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 18 CENSORED DEATHS 11 TERMINAL 31 | | | | UNCENSORED DEATHS | | 396 414 435 437 502 515 536 549 578 611 | | 611 639 680 695 696 702 704 704 | | CENSORED DEATHS | | 233 456 456 456 456 456 457 457 457 457 | | 457 | | | |--------------------------------------------------------------------------------| | DOSE = 337.5 MG/KG | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 25 CENSORED DEATHS 12 TERMINAL 23 | | | | UNCENSORED DEATHS | | 428 436 473 565 581 585 613 635 645 653 | | 658 659 659 672 684 687 696 704 704 704 | | 705 708 718 723 726 | | CENSORED DEATHS | | 122 240 456 456 456 456 456 457 457 457 | | 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 337.5 STOP | | ---------------------------- | | | | TOTAL 70 UNCENSORED DEATHS 17 CENSORED DEATHS 23 TERMINAL 30 | | | | UNCENSORED DEATHS | | 130 361 383 423 430 466 506 542 547 568 | | 585 644 648 662 684 696 704 | | CENSORED DEATHS | | 85 120 183 183 183 183 183 183 183 183 | | 183 183 240 456 456 456 456 456 457 457 | | 457 457 457 | | | ================================================================================== SALICYLAZOSULFAPYRIDINE 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 MG/KG | 100.0 100.0 100.0 100.0 100.0 95.9 91.8 87.8 83.7 71.4 | | | | | | | |0 | 100.0 100.0 100.0 100.0 100.0 97.9 91.7 87.5 81.3 64.6 | |MG/KG FEED |TD | | | | |84 MG/KG | 100.0 100.0 100.0 100.0 96.5 96.5 94.3 92.1 83.3 72.4 | | | | | | | |168 | 100.0 100.0 100.0 100.0 96.6 93.2 87.0 82.9 76.6 64.2 | |MG/KG | | | | | |337.5 | 100.0 100.0 100.0 100.0 100.0 94.5 94.5 88.2 73.5 48.3 | |MG/KG | | | | | |337.5 | 100.0 98.5 98.5 96.8 93.3 89.3 85.0 78.4 71.9 65.4 | |STOP | | | | | ================================================================================== SALICYLAZOSULFAPYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 0 84 MG/KG 168 337.5 337.5 | | MG/KG FEED RTD MG/KG MG/KG STOP | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 71.4% 64.6% 72.4% 64.2% 48.3% 65.4% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.043 ----- P=1.000N P=0.424 P=0.036 P=0.416 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 617.3 632.0 619.7 578.0 640.8 528.2 | |NATURAL DEATHS (C) | (25.4) (19.0) (28.8) (25.8) (17.2) (36.7) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 581.5 640.5 628.3 630.0 628.6 538.4 | |(STANDARD ERROR) | (24.2) (17.2) (19.8) (16.9) (17.8) (26.0) | | | | =============================================================================================================================== (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) SALICYLAZOSULFAPYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 737 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 14 CENSORED DEATHS 11 TERMINAL 35 | | | | UNCENSORED DEATHS | | 260 507 592 598 622 635 649 663 663 684 | | 691 692 703 709 | | CENSORED DEATHS | | 332 458 458 458 458 458 459 459 459 459 | | 459 | | | |--------------------------------------------------------------------------------| | DOSE = 84 MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 15 CENSORED DEATHS 11 TERMINAL 34 | | | | UNCENSORED DEATHS | | 218 395 396 432 472 501 544 583 632 648 | | 684 693 703 717 724 | | CENSORED DEATHS | | 280 458 458 458 458 458 459 459 459 459 | | 459 | | | |--------------------------------------------------------------------------------| | DOSE = 168 MG/KG | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 19 CENSORED DEATHS 10 TERMINAL 31 | | | | UNCENSORED DEATHS | | 544 619 621 624 625 667 687 691 691 692 | | 695 695 696 708 708 725 733 733 733 | | CENSORED DEATHS | | 458 458 458 458 458 459 459 459 459 459 | | | ================================================================================== SALICYLAZOSULFAPYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 737 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 337.5 MG/KG | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 15 CENSORED DEATHS 19 TERMINAL 26 | | | | UNCENSORED DEATHS | | 358 375 405 416 495 495 568 603 607 693 | | 696 703 704 709 733 | | CENSORED DEATHS | | 122 214 349 393 398 458 458 458 458 458 | | 459 459 459 459 459 508 508 508 508 | | | ================================================================================== SALICYLAZOSULFAPYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 737 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 737 (A) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 98.3 98.3 98.3 98.3 96.3 92.2 81.9 71.7 | | | | | | | |84 MG/KG | 100.0 100.0 98.3 98.3 94.9 91.2 87.0 85.0 80.8 70.5 | | | | | | | |168 | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 98.0 90.0 62.0 | |MG/KG | | | | | |337.5 | 100.0 100.0 100.0 98.2 92.9 92.9 88.3 83.3 80.8 65.6 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 84 MG/KG 168 337.5 | | MG/KG MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 71.7% 70.5% 62.0% 65.6% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.458 P=0.898 P=0.577 P=0.568 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 619.1 556.1 678.3 570.7 | |NATURAL DEATHS (C) | (31.2) (38.9) (11.5) (35.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 656.3 637.8 672.0 596.9 | |(STANDARD ERROR) | (16.1) (18.4) (13.4) (20.7) | | | | ================================================================================== (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) SALICYLAZOSULFAPYRIDINE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 0 MG/KG FEED RTD = 2 84 MG/KG = 3 168 MG/KG = 4 337.5 MG/KG = 5 337.5 STOP = 6 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 6 4 3 5 1 2 | 6 6 6 4 3354 112 3 2 | 6 6 51 1 3 12 2 5 3 | 664 6 4 1 21 5 2 3 3 P 90 + 6 464 4 1 25 2 1 3 3 E | 6 464 5 2 152 1 3 3 R | 64 4 5221 51 C | 6 64 4 2 21 3 112 E 80 + 6 6 13 1 N | 6 4 4 5 5 43 11 T | 66 6 422 3 3 | 55 5 22 11 1 S 70 + 55422 U | 5562 2 R | 54 2 2 V | I 60 + V | 55 A | 55 L | 55 50 + | 5 5 | | 40 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 47 obs hidden. SALICYLAZOSULFAPYRIDINE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 84 MG/KG = 2 168 MG/KG = 3 337.5 MG/KG = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 2 1 4 3 | 2 1 4 4 2 1 | 3 3 | 4 4 1 1 95 + 24 4 2 | 2 2 11 33 | 4 4 1 1 | 2 2 P 90 + 131 3 E | 42 2 4 R | 2 2 1 1 3 3 C | 4 4 1 1 E 85 + 2 2 N | T | 2 2 1 1 | 4 2 24 S 80 + 113 U | 224 R | V | 141 I 75 + 2 2 V | 311 A | 22 L | 41 1 70 + 3 2 2 | 4 4 | 3 3 | 65 + 44 | | 33 | 60 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 11 obs hidden.