TDMS Study 88122-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus ELMIRON DATE: 04/23/01 EXPERIMENT: 88122 TEST: 07 TIME: 15:41:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: C88122 PATHOLOGIST: GRUMBEIN, SONDRA CAS: 37319-17-8 ------------------------------------------------------------------------------------------------------------------------------------ final#1/Mice REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus ELMIRON DATE: 04/23/01 EXPERIMENT: 88122 TEST: 07 TIME: 15:41:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: C88122 PATHOLOGIST: GRUMBEIN, SONDRA CAS: 37319-17-8 ELMIRON STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 11 CENSORED DEATHS 0 TERMINAL 39 | | | | UNCENSORED DEATHS | | 420 477 590 599 606 620 632 646 664 690 | | 702 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 56 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 9 CENSORED DEATHS 1 TERMINAL 40 | | | | UNCENSORED DEATHS | | 311 346 455 508 508 508 688 707 728 | | CENSORED DEATHS | | 11 | | | |--------------------------------------------------------------------------------| | DOSE = 168 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 0 TERMINAL 38 | | | | UNCENSORED DEATHS | | 465 548 581 592 597 611 620 641 653 653 | | 680 725 | | CENSORED DEATHS | | NONE | | | ================================================================================== ELMIRON STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 504 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 2 TERMINAL 30 | | | | UNCENSORED DEATHS | | 483 492 498 539 576 584 590 617 621 626 | | 631 646 657 658 668 676 695 721 | | CENSORED DEATHS | | 11 17 | | | ================================================================================== ELMIRON STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 730 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 730 (A) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 100.0 98.0 96.0 96.0 92.0 82.0 78.0 | | | | | | | |56 MG/KG | 100.0 100.0 100.0 95.9 95.9 93.9 87.8 87.8 87.8 81.6 | | | | | | | |168 | 100.0 100.0 100.0 100.0 100.0 98.0 98.0 90.0 80.0 76.0 | |MG/KG | | | | | |504 | 100.0 100.0 100.0 100.0 100.0 97.9 91.7 85.4 70.8 62.5 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 56 MG/KG 168 504 | | MG/KG MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 78.0% 81.6% 76.0% 62.5% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.038 P=0.860N P=0.974 P=0.140 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 604.2 528.8 613.8 609.9 | |NATURAL DEATHS (C) | (25.9) (50.6) (19.2) (16.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 702.3 679.4 702.1 658.1 | |(STANDARD ERROR) | ( 9.2) (19.6) ( 8.4) (21.3) | | | | ================================================================================== (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) ELMIRON 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 12 CENSORED DEATHS 1 TERMINAL 37 | | | | UNCENSORED DEATHS | | 411 456 536 583 636 647 661 667 685 703 | | 717 723 | | CENSORED DEATHS | | 183 | | | |--------------------------------------------------------------------------------| | DOSE = 56 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 11 CENSORED DEATHS 1 TERMINAL 38 | | | | UNCENSORED DEATHS | | 281 485 541 555 642 681 681 703 703 711 | | 722 | | CENSORED DEATHS | | 18 | | | |--------------------------------------------------------------------------------| | DOSE = 168 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 13 CENSORED DEATHS 0 TERMINAL 37 | | | | UNCENSORED DEATHS | | 313 481 509 589 603 621 638 638 647 653 | | 667 677 717 | | CENSORED DEATHS | | NONE | | | ================================================================================== ELMIRON STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 504 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 0 TERMINAL 34 | | | | UNCENSORED DEATHS | | 401 509 517 579 621 645 652 660 661 683 | | 698 701 703 708 717 723 | | CENSORED DEATHS | | NONE | | | ================================================================================== ELMIRON 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 98.0 95.9 93.9 91.8 85.7 75.5 | | | | | | | |56 MG/KG | 100.0 100.0 100.0 98.0 98.0 95.9 93.9 91.8 89.8 77.6 | | | | | | | |168 | 100.0 100.0 100.0 98.0 98.0 96.0 94.0 90.0 80.0 74.0 | |MG/KG | | | | | |504 | 100.0 100.0 100.0 100.0 98.0 98.0 94.0 92.0 82.0 68.0 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 56 MG/KG 168 504 | | MG/KG MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 75.5% 77.6% 74.0% 68.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.359 P=0.962N P=0.968 P=0.544 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 618.8 609.5 596.4 636.1 | |NATURAL DEATHS (C) | (29.5) (40.8) (29.7) (22.8) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 691.6 688.5 694.5 699.3 | |(STANDARD ERROR) | (14.1) (17.7) (11.2) ( 9.4) | | | | ================================================================================== (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) ELMIRON KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 56 MG/KG = 2 168 MG/KG = 3 504 MG/KG = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100.00 + 1 2 1 3 4 | | 2 2 1 3 1 4 3 | 95.83 + 2 2 1 44 3 3 1 | | 2 42 4 3 11 | 91.67 + 4 4 311 | P | 44 3131 E | R 87.50 + 2 44 31 1 2 C | 3 131 E | 4 4 2 2 N | 3131 T 83.33 + 2 2 | 1 1 S | 44 22 U | 3 31 1 R 79.17 + 44 V | 3 1 31 I | 4 4 V | 33 A 75.00 + 44 L | | | 70.83 + 4 4 | | 44 | 66.67 + 4 4 | | 4 4 | 62.50 + 4 4 | ---+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+-- 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 105 WEEK NOTE: 7 obs hidden. ELMIRON KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 56 MG/KG = 2 168 MG/KG = 3 504 MG/KG = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 2 3 41 | | 2 3 41 1 32 4 | 1 32 34 12 95 + | 34 12 2 41 3 P | 4 3 3 4 E | 2 1 12 R 90 + 3 3 121 2 C | E | 3 314 1 N | 4 11 2 2 T 85 + | 33 1 1 S | 33 4 4 U | 1 12 R 80 + 3 3 4 41212 V | I | 33 44 11 2 V | 3 3 A 75 + 1 1 L | 443 3 | 44 | 70 + 44 | | 4 4 | 65 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 10 obs hidden.