TDMS Study 05090-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: American Biogenics DATE: 09/12/94 EXP: 05090 COUMARIN TIME: 06:36:33 TEST: 02 CAGES FROM 0000 TO LAST CAGE PAGE: 1 TEST TYPE: CHRONIC ROUTE: GAVAGE NTP C#: 07103B CONT: NO1-ES-45039 CAS: 91-64-5 PATHOLOGIST: R. DAHLGREN -------------------------------------------------------------------------------- REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: American Biogenics DATE: 09/12/94 EXP: 05090 COUMARIN TIME: 06:36:33 TEST: 02 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: GAVAGE NTP C#: 07103B CONT: NO1-ES-45039 CAS: 91-64-5 PATHOLOGIST: R. DAHLGREN COUMARIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 70 UNCENSORED DEATHS 6 CENSORED DEATHS 21 TERMINAL 43 | | | | UNCENSORED DEATHS | | 541 653 670 680 716 726 | | CENSORED DEATHS | | 455 455 455 455 455 456 456 456 456 456 | | 456 460 460 460 460 460 460 460 460 460 | | 460 | | | |--------------------------------------------------------------------------------| | DOSE = 50 MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 3 CENSORED DEATHS 20 TERMINAL 47 | | | | UNCENSORED DEATHS | | 532 607 701 | | CENSORED DEATHS | | 455 455 455 455 455 456 456 456 456 456 | | 460 460 460 460 460 460 460 460 460 460 | | | |--------------------------------------------------------------------------------| | DOSE = 100MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 7 CENSORED DEATHS 21 TERMINAL 42 | | | | UNCENSORED DEATHS | | 1 64 419 567 567 636 723 | | CENSORED DEATHS | | 455 455 455 455 455 456 456 456 456 456 | | 460 460 460 460 460 460 460 460 460 460 | | 525 | | | ================================================================================== COUMARIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 200MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 14 CENSORED DEATHS 19 TERMINAL 37 | | | | UNCENSORED DEATHS | | 177 323 412 476 498 541 558 608 659 661 | | 674 687 692 712 | | CENSORED DEATHS | | 455 455 455 455 455 456 456 456 456 460 | | 460 460 460 460 460 460 460 460 460 | | | ================================================================================== COUMARIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE 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) | | | |--------------------------------------------------------------------------------| | | | |VEHICLE | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 98.0 95.9 87.8 | |CONTROL | | | | | |50 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 98.0 96.0 94.0 | | | | | | | |100MG/KG | 97.1 97.1 97.1 97.1 95.7 95.7 95.7 91.6 89.5 87.4 | | | | | | | |200MG/KG | 100.0 98.6 98.6 97.1 95.7 93.7 89.7 87.7 81.8 73.8 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE 50 MG/KG 100MG/KG 200MG/KG | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 87.8% 94.0% 87.4% 73.8% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.008 P=0.476N P=0.927 P=0.075 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 664.3 613.3 425.3 548.4 | |NATURAL DEATHS (C) | (27.1) (48.9) ( 107) (42.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 642.1 646.5 618.2 619.3 | |(STANDARD ERROR) | (14.8) (14.7) (19.2) (16.6) | | | | ================================================================================== (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) COUMARIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 70 UNCENSORED DEATHS 15 CENSORED DEATHS 22 TERMINAL 33 | | | | UNCENSORED DEATHS | | 12 159 367 474 550 557 589 589 623 673 | | 683 683 694 708 714 | | CENSORED DEATHS | | 2 2 4 4 455 455 455 456 456 456 | | 456 456 460 460 460 460 460 460 460 460 | | 460 460 | | | |--------------------------------------------------------------------------------| | DOSE = 50 MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 10 CENSORED DEATHS 20 TERMINAL 40 | | | | UNCENSORED DEATHS | | 495 593 622 635 635 670 673 683 715 722 | | CENSORED DEATHS | | 455 455 456 456 456 456 456 456 456 456 | | 460 460 460 460 460 460 460 460 460 460 | | | |--------------------------------------------------------------------------------| | DOSE = 100MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 8 CENSORED DEATHS 20 TERMINAL 42 | | | | UNCENSORED DEATHS | | 4 70 564 586 672 679 689 694 | | CENSORED DEATHS | | 3 455 455 455 456 456 456 456 456 456 | | 456 460 460 460 460 460 460 460 460 460 | | | ================================================================================== COUMARIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 200MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 21 CENSORED DEATHS 21 TERMINAL 28 | | | | UNCENSORED DEATHS | | 139 225 253 257 260 288 358 426 496 508 | | 611 615 615 637 655 678 684 684 700 700 | | 716 | | CENSORED DEATHS | | 48 455 455 456 456 456 456 456 456 456 | | 460 460 460 460 460 460 460 460 460 460 | | 718 | | | ================================================================================== COUMARIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE 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) | | | |--------------------------------------------------------------------------------| | | | |VEHICLE | 98.5 97.0 97.0 97.0 95.5 93.3 93.3 84.8 82.7 70.0 | |CONTROL | | | | | |50 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 96.0 90.0 80.0 | | | | | | | |100MG/KG | 97.1 97.1 97.1 97.1 97.1 97.1 97.1 93.1 93.1 85.0 | | | | | | | |200MG/KG | 100.0 98.6 92.8 89.9 89.9 88.4 84.2 84.2 73.7 61.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE 50 MG/KG 100MG/KG 200MG/KG | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 70.0% 80.0% 85.0% 61.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.105 P=0.240N P=0.124N P=0.330 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 538.3 644.3 494.8 500.2 | |NATURAL DEATHS (C) | (53.9) (21.0) ( 102) (42.6) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 577.0 639.4 618.2 576.9 | |(STANDARD ERROR) | (24.8) (14.5) (20.8) (20.9) | | | | ================================================================================== (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) COUMARIN KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 50 MG/KG = 2 100MG/KG = 3 200MG/KG = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 13 4 2 1 | 3 3 4 4 | 3 4 43 2 1 2 1 | 43 4 3 2 1 1 2 P 95 + E | 4 4 1 1 2 2 R | C | 4 4 3 3 1 1 E 90 + 4 4 3 11 N | T | 4 4 1 1 | 4 4 S 85 + U | R | V | 4 4 I 80 + 4 4 V | A | L | 4 4 75 + | 4 4 | | 70 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 6 obs hidden. COUMARIN KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 50 MG/KG = 2 100MG/KG = 3 200MG/KG = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 131 4 2 | 31 3 4 1 4 | 3 1 4 4 1 2 3 2 | 2 2 95 + 1 1 3 3 | 44 1 1 2 2 | 4 4 3 3 | 4 4 11 33 P 90 + 4 4 2 2 E | 4 4 1 1 3 3 R | 22 33 C | 4 4 22 E 85 + 1 1 3 3 N | 4 4 2 2 T | 1 1 22 | S 80 + 11 2 2 U | R | 4 4 V | 4 4 1 1 I 75 + V | 4 4 1 1 A | L | 44 70 + 1 1 | | 4 4 | 65 + | 4 4 | | 4 4 60 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 3 obs hidden.