TDMS Study 56348-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus CITRAL DATE: 07/05/01 EXPERIMENT: 56348 TEST: 03 TIME: 13:28:55 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: C56348 PATHOLOGIST: SINGER, ALLEN CAS: 5392-40-5 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 UNTREAT CONTROL INCLUDE 002 UNTREAT CONTROL INCLUDE 005 1000 PPM INCLUDE 006 1000 PPM INCLUDE 007 2000 PPM INCLUDE 008 2000 PPM INCLUDE 009 4000 PPM INCLUDE 010 4000 PPM NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus CITRAL DATE: 07/05/01 EXPERIMENT: 56348 TEST: 03 TIME: 13:28:55 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: C56348 PATHOLOGIST: SINGER, ALLEN CAS: 5392-40-5 CITRAL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = UNTREAT CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 20 CENSORED DEATHS 0 TERMINAL 30 | | | | UNCENSORED DEATHS | | 450 505 549 589 600 610 610 617 639 639 | | 653 660 660 674 674 674 688 693 695 712 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 0 TERMINAL 32 | | | | UNCENSORED DEATHS | | 478 505 526 639 639 660 671 674 688 692 | | 694 695 695 709 709 716 720 725 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 2000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 15 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 573 600 624 639 660 674 688 701 709 709 | | 712 720 720 722 723 | | CENSORED DEATHS | | NONE | | | ================================================================================== CITRAL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 4000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 0 TERMINAL 34 | | | | UNCENSORED DEATHS | | 397 520 544 596 628 636 639 655 674 680 | | 684 695 709 709 720 723 | | CENSORED DEATHS | | NONE | | | ================================================================================== CITRAL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 726 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 726 (A) | | | |--------------------------------------------------------------------------------| | | | |UNTREAT | 100.0 100.0 100.0 100.0 100.0 98.0 96.0 90.0 74.0 60.0 | |CONTROL | | | | | |1000 PPM | 100.0 100.0 100.0 100.0 100.0 98.0 94.0 94.0 88.0 64.0 | | | | | | | |2000 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 96.0 90.0 70.0 | | | | | | | |4000 PPM | 100.0 100.0 100.0 100.0 98.0 98.0 94.0 92.0 84.0 68.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | UNTREAT 1000 PPM 2000 PPM 4000 PPM | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 60.0% 64.0% 70.0% 68.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.364N P=0.597N P=0.237N P=0.442N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 629.6 657.5 678.3 638.1 | |NATURAL DEATHS (C) | (14.9) (17.8) (12.6) (21.9) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 687.4 701.3 711.7 697.9 | |(STANDARD ERROR) | ( 9.0) ( 7.9) ( 4.8) ( 9.0) | | | | ================================================================================== (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) CITRAL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 732 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = UNTREAT CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 15 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 508 519 588 595 609 622 627 635 636 650 | | 686 719 719 719 722 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 400 515 582 594 612 645 659 662 687 694 | | 708 708 708 712 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 2000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 445 453 504 510 595 638 649 673 690 694 | | 694 714 719 721 | | CENSORED DEATHS | | NONE | | | ================================================================================== CITRAL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 732 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 4000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 386 432 473 491 519 588 617 617 687 687 | | 687 694 708 719 | | CENSORED DEATHS | | NONE | | | ================================================================================== CITRAL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 732 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 732 (A) | | | |--------------------------------------------------------------------------------| | | | |UNTREAT | 100.0 100.0 100.0 100.0 100.0 100.0 96.0 92.0 80.0 70.0 | |CONTROL | | | | | |1000 PPM | 100.0 100.0 100.0 100.0 98.0 98.0 96.0 92.0 84.0 72.0 | | | | | | | |2000 PPM | 100.0 100.0 100.0 100.0 100.0 96.0 92.0 90.0 86.0 72.0 | | | | | | | |4000 PPM | 100.0 100.0 100.0 100.0 98.0 94.0 90.0 88.0 84.0 72.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | UNTREAT 1000 PPM 2000 PPM 4000 PPM | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 70.0% 72.0% 72.0% 72.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=1.000N P=0.973N P=0.983N P=1.000N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 636.9 634.7 621.4 593.2 | |NATURAL DEATHS (C) | (17.7) (23.9) (27.1) (30.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 703.5 704.8 701.0 693.1 | |(STANDARD ERROR) | ( 8.1) ( 9.0) (10.2) (12.1) | | | | ================================================================================== (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) CITRAL KAPLAN-MEIER SURVIVAL CURVES UNTREAT CONTROL = 1 1000 PPM = 2 2000 PPM = 3 4000 PPM = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 4 1 2 3 | | 4 1 2 1 4 3 3 | 96 + 1 42 41 3 3 | | 2 41 14 3 2 | 92 + 11 4 3 3 | | 1 1 442 2 3 | P 88 + 44 223 3 E | R | 11 4 4 22 3 3 C | E 84 + 1 1 4 2 2 33 N | T | 44 | S 80 + 1 1 22 U | R | 1 1 4 4 33 V | I 76 + 4 4 V | A | 1 1 2 233 L | 72 + 44 | | 223 | 68 + 1 1 4 | | 22 | 64 + 11 2 | | 1 1 | 60 + 1 1 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 11 obs hidden. CITRAL KAPLAN-MEIER SURVIVAL CURVES UNTREAT CONTROL = 1 1000 PPM = 2 2000 PPM = 3 4000 PPM = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 2 3 1 | | 4 2 4 3 3 12 1 | 96 + 4 3 4 3 2 1 1 | | 4 433 1 1 | P 92 + 4 3 4 1 12 E | R | 4 4 3 121 32 C | E 88 + 4 11 32 2 N | T | 11 3 3 | S 84 + 4 2 3 2 U | R | 1 1 22 V | I 80 + 1 1 2 2 V | A | 143 31 L | 76 + 4 33 | | 44 | 72 + 211 2 | | 1 1 | 68 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 20 obs hidden.