TDMS Study 91005-08 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst METHYLENE BLUE TRIHYDRATE DATE: 04/26/05 EXPERIMENT: 91005 TEST: 08 TIME: 09:35:27 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-05451 ROUTE: GAVAGE NTP C#: 91005C PATHOLOGIST: FARNELL, DANIEL CAS: 7220-79-3 ------------------------------------------------------------------------------------------------------------------------------------ FINAL #1 MICE REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst METHYLENE BLUE TRIHYDRATE DATE: 04/26/05 EXPERIMENT: 91005 TEST: 08 TIME: 09:35:27 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-05451 ROUTE: GAVAGE NTP C#: 91005C PATHOLOGIST: FARNELL, DANIEL CAS: 7220-79-3 METHYLENE BLUE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 15 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 478 530 536 544 548 559 605 605 605 640 | | 665 673 694 723 723 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 2.5 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 10 CENSORED DEATHS 2 TERMINAL 38 | | | | UNCENSORED DEATHS | | 452 627 638 647 670 676 694 704 717 725 | | CENSORED DEATHS | | 15 610 | | | |--------------------------------------------------------------------------------| | DOSE = 12.5 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 0 TERMINAL 38 | | | | UNCENSORED DEATHS | | 261 605 605 627 638 645 673 680 690 695 | | 696 727 | | CENSORED DEATHS | | NONE | | | ================================================================================== METHYLENE BLUE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 25 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 7 CENSORED DEATHS 2 TERMINAL 41 | | | | UNCENSORED DEATHS | | 506 641 687 690 694 705 716 | | CENSORED DEATHS | | 610 610 | | | ================================================================================== METHYLENE BLUE TRIHYDRATE 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) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 100.0 100.0 98.0 92.0 82.0 78.0 70.0 | | | | | | | |2.5 | 100.0 100.0 100.0 100.0 100.0 98.0 98.0 98.0 91.7 79.2 | |MG/KG | | | | | |12.5 | 100.0 100.0 98.0 98.0 98.0 98.0 98.0 94.0 88.0 76.0 | |MG/KG | | | | | |25 | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 98.0 95.9 85.5 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 2.5 12.5 25 | | MG/KG MG/KG MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 70.0% 79.2% 76.0% 85.5% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.131N P=0.325N P=0.547N P=0.081N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 608.5 655.0 628.5 662.7 | |NATURAL DEATHS (C) | (19.6) (24.9) (35.2) (27.6) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 692.9 697.5 704.9 715.0 | |(STANDARD ERROR) | ( 9.8) (15.5) (10.2) ( 5.8) | | | | ================================================================================== (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) METHYLENE BLUE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 1 TERMINAL 33 | | | | UNCENSORED DEATHS | | 550 568 604 617 627 638 638 650 655 663 | | 666 673 704 716 718 721 | | CENSORED DEATHS | | 185 | | | |--------------------------------------------------------------------------------| | DOSE = 2.5 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 9 CENSORED DEATHS 1 TERMINAL 40 | | | | UNCENSORED DEATHS | | 521 533 585 589 616 673 680 688 720 | | CENSORED DEATHS | | 3 | | | |--------------------------------------------------------------------------------| | DOSE = 12.5 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 7 CENSORED DEATHS 1 TERMINAL 42 | | | | UNCENSORED DEATHS | | 568 627 645 705 716 716 726 | | CENSORED DEATHS | | 283 | | | ================================================================================== METHYLENE BLUE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 25 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 7 CENSORED DEATHS 0 TERMINAL 43 | | | | UNCENSORED DEATHS | | 445 471 528 649 659 680 722 | | CENSORED DEATHS | | NONE | | | ================================================================================== METHYLENE BLUE TRIHYDRATE 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) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 93.9 79.6 67.3 | | | | | | | |2.5 | 100.0 100.0 100.0 100.0 100.0 100.0 95.9 91.8 89.8 81.6 | |MG/KG | | | | | |12.5 | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 98.0 93.9 85.7 | |MG/KG | | | | | |25 | 100.0 100.0 100.0 100.0 100.0 96.0 94.0 94.0 90.0 86.0 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 2.5 12.5 25 | | MG/KG MG/KG MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 67.3% 81.6% 85.7% 86.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.067N P=0.179N P=0.046N P=0.055N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 650.5 622.8 671.9 593.4 | |NATURAL DEATHS (C) | (12.7) (23.7) (22.6) (41.6) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 693.0 695.4 712.1 710.0 | |(STANDARD ERROR) | (12.3) (15.8) ( 9.7) ( 8.7) | | | | ================================================================================== (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) METHYLENE BLUE TRIHYDRATE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 2.5 MG/KG = 2 12.5 MG/KG = 3 25 MG/KG = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 3 2 1 4 | | 3 2 1 4 1 3 2 4 | 11 2 2 4 P 95 + E | 11 3 3 22 R | 11 3 3 C | 2 2 44 E 90 + 11 33 22 44 N | T | 1 1 3 2 24 4 | 33 S 85 + 22 4 4 U | 33 2 2 R | 1 1 33 V | 22 I 80 + 1 1 V | 2 2 A | 1 1 3 3 L | 1 1 3 3 75 + | 1 1 | | 70 + 1 1 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 5 obs hidden. METHYLENE BLUE TRIHYDRATE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 2.5 MG/KG = 2 12.5 MG/KG = 3 25 MG/KG = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 2 1 3 | | 4 4 2 2 1 1 3 | 4 42 1 2 1 3 3 95 + | 4 2 2 1 1 3 3 P | 4 4 E | 2 211 3 3 R 90 + 2 1 1 4 24 C | E | 22 33 N | 11 22 3 3 T 85 + | 11 2 2 S | U | 1 1 2 2 R 80 + 11 V | I | 11 V | A 75 + 1 1 L | 1 1 | | 70 + | | 1 1 | 65 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 9 obs hidden.