TDMS Study 05085-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus DATE: 09/11/94 EXP: 05085 MANGANESE SULFATE TIME: 02:32:54 TEST: 01 CAGES FROM 0000 TO LAST CAGE PAGE: 1 TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 61143B CONT: N01-ES-45041 CAS: 7785-87-7 PATHOLOGIST: J. TOFT -------------------------------------------------------------------------------- REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus DATE: 09/11/94 EXP: 05085 MANGANESE SULFATE TIME: 02:32:54 TEST: 01 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 61143B CONT: N01-ES-45041 CAS: 7785-87-7 PATHOLOGIST: J. TOFT MANGANESE SULFATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 27 CENSORED DEATHS 18 TERMINAL 25 | | | | UNCENSORED DEATHS | | 95 269 456 495 526 547 562 571 578 590 | | 603 603 610 612 621 627 642 655 670 673 | | 673 677 690 691 695 701 726 | | CENSORED DEATHS | | 275 275 275 275 275 276 276 276 437 437 | | 437 437 437 437 437 437 437 437 | | | |--------------------------------------------------------------------------------| | DOSE = 1500 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 34 CENSORED DEATHS 19 TERMINAL 17 | | | | UNCENSORED DEATHS | | 124 333 346 451 466 532 578 590 613 613 | | 613 635 642 652 658 659 666 666 670 674 | | 677 682 683 684 690 694 694 698 711 717 | | 723 726 726 726 | | CENSORED DEATHS | | 275 275 275 275 275 276 276 276 276 276 | | 437 437 437 437 437 437 437 437 437 | | | |--------------------------------------------------------------------------------| | DOSE = 5000 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 29 CENSORED DEATHS 19 TERMINAL 22 | | | | UNCENSORED DEATHS | | 380 417 481 499 509 519 528 528 557 582 | | 606 613 618 621 631 635 654 659 663 684 | | 690 698 701 703 711 714 715 727 728 | | CENSORED DEATHS | | 275 275 275 275 275 276 276 276 276 276 | | 437 437 437 437 437 437 437 437 437 | | | ================================================================================== MANGANESE SULFATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 15000 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 45 CENSORED DEATHS 18 TERMINAL 7 | | | | UNCENSORED DEATHS | | 268 275 354 498 498 527 557 568 618 626 | | 631 631 632 632 632 638 638 652 655 660 | | 660 661 661 663 670 673 677 684 687 687 | | 690 691 698 701 707 711 713 713 715 715 | | 715 719 726 726 727 | | CENSORED DEATHS | | 275 275 275 275 276 276 276 276 276 276 | | 437 437 437 437 437 437 437 437 | | | ================================================================================== MANGANESE SULFATE 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 PPM | 100.0 98.6 97.1 97.1 97.1 95.2 91.3 77.7 66.1 48.6 | | | | | | | |1500 PPM | 100.0 98.6 98.6 95.2 95.2 91.3 89.3 85.3 69.4 33.7 | | | | | | | |5000 PPM | 100.0 100.0 100.0 100.0 96.7 94.7 84.8 80.9 63.1 43.4 | | | | | | | |15000 PPM | 100.0 100.0 98.6 95.5 95.5 95.5 89.6 85.7 54.6 13.6 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 1500 PPM 5000 PPM 15000 PP| | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 48.6% 33.7% 43.4% 13.6% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.004 P=0.381 P=0.872 P=0.006 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 587.3 618.0 612.8 635.1 | |NATURAL DEATHS (C) | (26.2) (22.7) (17.9) (16.0) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 580.8 572.8 578.5 570.5 | |(STANDARD ERROR) | (20.3) (20.9) (19.8) (19.8) | | | | ================================================================================== (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) MANGANESE SULFATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 13 CENSORED DEATHS 20 TERMINAL 37 | | | | UNCENSORED DEATHS | | 547 585 599 620 624 638 642 675 690 694 | | 694 699 728 | | CENSORED DEATHS | | 275 275 275 275 275 275 276 276 276 276 | | 437 437 437 437 437 437 437 437 437 437 | | | |--------------------------------------------------------------------------------| | DOSE = 1500 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 13 CENSORED DEATHS 20 TERMINAL 37 | | | | UNCENSORED DEATHS | | 396 451 491 540 543 548 557 568 609 667 | | 673 718 718 | | CENSORED DEATHS | | 275 275 275 275 275 276 276 276 276 276 | | 437 437 437 437 437 437 437 437 437 437 | | | |--------------------------------------------------------------------------------| | DOSE = 5000 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 8 CENSORED DEATHS 20 TERMINAL 42 | | | | UNCENSORED DEATHS | | 78 528 571 599 609 663 666 684 | | CENSORED DEATHS | | 45 275 275 275 275 275 276 276 276 276 | | 276 437 437 437 437 437 437 437 437 437 | | | ================================================================================== MANGANESE SULFATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 15000 PPM | | --------------------- | | | | TOTAL 68 UNCENSORED DEATHS 12 CENSORED DEATHS 20 TERMINAL 36 | | | | UNCENSORED DEATHS | | 495 527 642 663 680 684 694 701 701 701 | | 715 723 | | CENSORED DEATHS | | 275 275 275 275 276 276 276 276 276 276 | | 437 437 437 437 437 437 437 437 437 437 | | | ================================================================================== MANGANESE SULFATE 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 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 94.0 86.0 74.0 | | | | | | | |1500 PPM | 100.0 100.0 100.0 100.0 98.3 96.3 90.3 84.3 82.3 74.3 | | | | | | | |5000 PPM | 98.6 98.6 98.6 98.6 98.6 98.6 96.5 92.5 88.5 84.5 | | | | | | | |15000 PPM| 100.0 100.0 100.0 100.0 100.0 100.0 95.8 95.8 91.7 75.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 1500 PPM 5000 PPM 15000 P|M | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 74.0% 74.3% 84.5% 75.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.914N P=1.000 P=0.378N P=0.984N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 648.8 575.3 549.8 660.5 | |NATURAL DEATHS (C) | (14.7) (27.5) (69.9) (21.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 607.6 594.0 596.4 607.3 | |(STANDARD ERROR) | (20.3) (20.6) (23.2) (21.0) | | | | ================================================================================== (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) MANGANESE SULFATE KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 1500 PPM = 2 5000 PPM = 3 15000 PPM = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 2 4 3 | 1 2 14 2 24 3 3 1 3 | 24 21 3 13 | 2 2 133 1 1 90 + 3 32 141 2 | 4112 2 | 3 3 11 2 244 | 3 13 1 1 44 80 + 3 32 2 | 113 22 P | 11 2 2 E | 1134 2 2 R 70 + 131 3 22 C | 1 1 3 E | 1 411 N | 3223 T 60 + 2233 | 1 133 S | 44 11 U | 4422113 R 50 + 1331 V | 444 31 1 I | 2 2 V | 222 3 A 40 + 44 L | 44 | | 44 2 2 30 + | 44 | | 20 + 44 | | | 4 4 10 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 40 obs hidden. MANGANESE SULFATE KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 1500 PPM = 2 5000 PPM = 3 15000 PPM = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 3 2 4 1 | 3 2 2 3 | 4 4 1 1 | 2 2 3 3 1 1 4 P 95 + 3 3 E | 2 2 1 1 4 4 R | 33 11 C | 4 4 E 90 + 22 3 1 1 3 N | 22 33 T | 4 4 | 2 2 1 313 S 85 + 3 44 3 U | 2 2 1 1 R | 2 2 11 V | I 80 + 22 V | 2 4 2 A | 44 L | 1 1 75 + 4 4 | 21 1 | | 70 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 6 obs hidden.