TDMS Study 91005-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst METHYLENE BLUE TRIHYDRATE DATE: 03/25/05 EXPERIMENT: 91005 TEST: 07 TIME: 10:15:16 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-05451 ROUTE: GAVAGE NTP C#: 91005C PATHOLOGIST: HERSCHELL, GILES CAS: 7220-79-3 ------------------------------------------------------------------------------------------------------------------------------------ FINAL #1 RATS 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: 03/25/05 EXPERIMENT: 91005 TEST: 07 TIME: 10:15:16 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-05451 ROUTE: GAVAGE NTP C#: 91005C PATHOLOGIST: HERSCHELL, GILES CAS: 7220-79-3 METHYLENE BLUE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 0 TERMINAL 31 | | | | UNCENSORED DEATHS | | 453 544 563 586 586 616 620 641 642 645 | | 649 662 662 675 685 694 694 702 712 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 5 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 473 540 540 561 568 576 582 590 652 652 | | 673 673 682 712 720 722 723 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 25 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 10 CENSORED DEATHS 1 TERMINAL 39 | | | | UNCENSORED DEATHS | | 586 619 619 637 649 690 690 710 712 726 | | CENSORED DEATHS | | 489 | | | ================================================================================== METHYLENE BLUE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 50 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 2 TERMINAL 31 | | | | UNCENSORED DEATHS | | 401 465 504 530 563 576 597 626 626 652 | | 658 666 687 692 703 715 717 | | CENSORED DEATHS | | 191 508 | | | ================================================================================== METHYLENE BLUE TRIHYDRATE 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 98.0 96.0 90.0 74.0 62.0 | | | | | | | |5 MG/KG | 100.0 100.0 100.0 100.0 100.0 98.0 94.0 84.0 80.0 66.0 | | | | | | | |25 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 98.0 89.8 79.6 | | | | | | | |50 MG/KG | 100.0 100.0 100.0 100.0 98.0 95.9 91.8 85.5 77.2 64.7 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 62.0% 66.0% 79.6% 64.7% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.750N P=0.813N P=0.067N P=0.957N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 633.2 625.8 663.8 610.5 | |NATURAL DEATHS (C) | (14.8) (18.7) (15.2) (22.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 692.6 693.9 711.2 673.5 | |(STANDARD ERROR) | ( 8.7) ( 9.4) ( 6.5) (15.1) | | | | ================================================================================== (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 RATS 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 | | 344 516 563 591 638 640 648 648 652 652 | | 652 668 674 698 710 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 5 MG/KG | | --------------------- | | | | TOTAL 49 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 32 | | | | UNCENSORED DEATHS | | 395 568 576 585 621 628 641 644 648 663 | | 677 687 694 702 702 702 710 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 25 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 492 521 540 557 560 563 593 596 596 646 | | 651 687 702 723 | | CENSORED DEATHS | | NONE | | | ================================================================================== METHYLENE BLUE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 50 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 1 TERMINAL 35 | | | | UNCENSORED DEATHS | | 223 239 284 312 349 509 527 544 568 573 | | 677 677 687 725 | | CENSORED DEATHS | | 480 | | | ================================================================================== METHYLENE BLUE TRIHYDRATE 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) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 98.0 98.0 98.0 96.0 92.0 78.0 70.0 | | | | | | | |5 MG/KG | 100.0 100.0 100.0 100.0 98.0 98.0 98.0 91.8 79.6 65.3 | | | | | | | |25 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 94.0 82.0 78.0 72.0 | | | | | | | |50 MG/KG | 100.0 100.0 96.0 90.0 90.0 90.0 83.9 79.8 79.8 71.6 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 5 MG/KG 25 MG/KG 50 MG/KG | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 70.0% 65.3% 72.0% 71.6% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.895N P=0.806 P=1.000N P=1.000 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 619.6 637.8 601.9 492.4 | |NATURAL DEATHS (C) | (23.5) (18.8) (18.8) (47.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 696.2 697.4 693.4 657.8 | |(STANDARD ERROR) | ( 9.9) ( 9.0) ( 9.6) (20.2) | | | | ================================================================================== (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) METHYLENE BLUE TRIHYDRATE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 5 MG/KG = 2 25 MG/KG = 3 50 MG/KG = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 1 2 3 | | 4 1 42 1 3 3 | 4 4 1 1 95 + | 4 4 2 1 1 3 3 | 22 | 4 4 3 3 P 90 + 4221 1 3 3 E | R | 22 4 11 C | 2 2 1 1 3 3 E 85 + 4 4 N | 2 2 T | 11 | 4 4 3 3 S 80 + 2 2 3 3 U | R | 14 14 V | 22 I 75 + 4 4 V | 1 12 2 A | 11 22 L | 4 4 70 + 1 1 22 | 4 4 | | 11 2 2 65 + 4 4 | 11 | 1 1 | 60 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 7 obs hidden. METHYLENE BLUE TRIHYDRATE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 5 MG/KG = 2 25 MG/KG = 3 50 MG/KG = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 1 2 3 | | 4 4 1 2 3 1 3 2 | 4 4 1 3 3 122 95 + | 4 4 3 31 22 1 P | 4 4 1 1 E | 2 2 R 90 + 4 4 33 22 C | E | 4 4 3 3 2 11 N | 4 4 33 T 85 + | 4 4 211 S | 3 3 U | 2 2 R 80 + 4 2 2 V | I | 31 12 2 V | 11 3 3 A 75 + 22 L | 1 412 3 | 1 1 3 3 | 4 4 70 + 1 1 | | 22 | 65 + 2 2 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 12 obs hidden.