TDMS Study 05099-08 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst SALICYLAZOSULFAPYRIDINE DATE: 04/03/96 EXPERIMENT: 05099 TEST: 08 TIME: 20:46:43 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85233 ROUTE: GAVAGE NTP C#: 61552B PATHOLOGIST: R.B. THOMPSON 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: 08 TIME: 20:46:43 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85233 ROUTE: GAVAGE NTP C#: 61552B PATHOLOGIST: R.B. THOMPSON CAS: 599-79-1 SALICYLAZOSULFAPYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 8 CENSORED DEATHS 12 TERMINAL 40 | | | | UNCENSORED DEATHS | | 420 420 610 611 658 662 666 689 | | CENSORED DEATHS | | 150 351 456 456 456 456 456 456 456 456 | | 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 0 MG/KG FEED RTD | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 4 CENSORED DEATHS 11 TERMINAL 45 | | | | UNCENSORED DEATHS | | 574 601 610 633 | | CENSORED DEATHS | | 151 456 456 456 456 456 456 456 456 456 | | 456 | | | |--------------------------------------------------------------------------------| | DOSE = 675 MG/KG | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 9 CENSORED DEATHS 10 TERMINAL 41 | | | | UNCENSORED DEATHS | | 75 288 567 588 611 652 665 666 700 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 456 | | | ================================================================================== SALICYLAZOSULFAPYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1350 MG/KG | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 9 CENSORED DEATHS 10 TERMINAL 41 | | | | UNCENSORED DEATHS | | 402 504 505 611 648 678 681 681 702 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 2700 MG/KG | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 4 CENSORED DEATHS 10 TERMINAL 46 | | | | UNCENSORED DEATHS | | 6 7 497 647 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 456 | | | ================================================================================== SALICYLAZOSULFAPYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE 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 MG/KG | 100.0 100.0 100.0 100.0 96.6 96.6 96.6 96.6 88.2 84.0 | | | | | | | |0 | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 95.9 91.8 91.8 | |MG/KG FEED |TD | | | | |675 | 98.3 98.3 98.3 96.7 96.7 96.7 96.7 92.6 86.6 82.6 | |MG/KG | | | | | |1350 | 100.0 100.0 100.0 100.0 98.3 98.3 94.3 94.3 90.3 82.3 | |MG/KG | | | | | |2700 | 96.7 96.7 96.7 96.7 96.7 96.7 94.7 94.7 92.6 92.6 | |MG/KG | | | | | ================================================================================== SALICYLAZOSULFAPYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 728 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 0 675 1350 2700 | | MG/KG FEED RTD MG/KG MG/KG MG/KG | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 84.0% 91.8% 82.6% 82.3% 92.6% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.638N ----- P=1.000 P=1.000 P=0.350N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 592.0 604.5 534.7 601.3 289.3 | |NATURAL DEATHS (C) | (38.7) (12.2) (70.4) (35.2) ( 166) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 648.6 664.8 653.7 663.7 653.4 | |(STANDARD ERROR) | (17.4) (15.9) (17.6) (14.3) (20.6) | | | | =============================================================================================================================== (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 MICE FIRST TERMINAL SACRIFICE AT 735 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 7 CENSORED DEATHS 12 TERMINAL 41 | | | | UNCENSORED DEATHS | | 324 429 476 518 595 708 723 | | CENSORED DEATHS | | 14 74 457 457 457 457 457 457 457 457 | | 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 675 MG/KG | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 9 CENSORED DEATHS 10 TERMINAL 41 | | | | UNCENSORED DEATHS | | 224 297 471 493 539 551 620 723 732 | | CENSORED DEATHS | | 457 457 457 457 457 457 457 457 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 1350 MG/KG | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 12 CENSORED DEATHS 11 TERMINAL 37 | | | | UNCENSORED DEATHS | | 9 171 316 420 588 618 660 661 663 686 | | 693 732 | | CENSORED DEATHS | | 457 457 457 457 457 457 457 457 457 457 | | 465 | | | ================================================================================== SALICYLAZOSULFAPYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 735 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 2700 MG/KG | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 10 CENSORED DEATHS 12 TERMINAL 38 | | | | UNCENSORED DEATHS | | 67 70 583 603 604 610 655 659 660 695 | | CENSORED DEATHS | | 2 72 457 457 457 457 457 457 457 457 | | 457 457 | | | ================================================================================== SALICYLAZOSULFAPYRIDINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 735 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 735 (A) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 98.3 98.3 94.5 92.4 90.3 90.3 86.1 | | | | | | | |675 | 100.0 100.0 98.3 96.7 96.7 94.7 90.6 88.6 86.6 82.6 | |MG/KG | | | | | |1350 | 98.3 96.7 96.7 95.0 93.3 93.3 93.3 91.3 83.0 76.7 | |MG/KG | | | | | |2700 | 96.6 96.6 96.6 96.6 96.6 96.6 96.6 90.3 81.9 79.8 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 675 1350 2700 | | MG/KG MG/KG MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 86.1% 82.6% 76.7% 79.8% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.487 P=0.837 P=0.327 P=0.595 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 539.0 516.7 518.1 520.6 | |NATURAL DEATHS (C) | (55.3) (57.5) (68.0) (76.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 642.8 655.9 640.8 629.7 | |(STANDARD ERROR) | (21.4) (17.3) (20.5) (24.2) | | | | ================================================================================== (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) SALICYLAZOSULFAPYRIDINE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 0 MG/KG FEED RTD = 2 675 MG/KG = 3 1350 MG/KG = 4 2700 MG/KG = 5 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 15 3 4 1 2 | | | 3 3 4 4 98 + 2 2 | | | 5 3 1 544 3 1 96 + 2 2 | P | E | 5 4 3 3 4 5 R 94 + 2 2 C | E | N | 3 1 41 5 T 92 + 2 2 | S | U | 3 41 1 4 R 90 + V | I | V | 3 3 44 A 88 + 11 L | | | 33 86 + 1 1 | | | 3 4 34 84 + 1 1 | | | 34 3 82 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 9 obs hidden. SALICYLAZOSULFAPYRIDINE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 675 MG/KG = 2 1350 MG/KG = 3 2700 MG/KG = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100.0 +1 3 4 2 1 | | | 3 3 2 2 1 1 97.5 + | 4 3 2 3 2 4 | 1 1 | 95.0 + 3 3 | 1 2 1 4 4 | | 3 3 P 92.5 + 2 1 2 1 E | R | 3 3 C | 2 2 E 90.0 + 1 44 1 N | 3 3 T | 2 2 | 4 4 1 1 S 87.5 + U | 2 2 R | 4 4 1 1 V | I 85.0 + V | 2 2 A | L | 3 3 82.5 + 2 | 4 4 | | 33 80.0 + 4 4 | | 3 3 | 77.5 + | 3 | | 75.0 + | -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 4 obs hidden.