TDMS Study 05079-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: LITRI DATE: 09/10/94 EXP: 05079 TALC TIME: 17:34:02 TEST: 02 CAGES FROM 0000 TO LAST CAGE PAGE: 1 TEST TYPE: CHRONIC ROUTE: RESPIRATORY EXPOSURE WHOLE NTP C#: 06008 CONT: CAS: 14807966 PATHOLOGIST: B. JONES F. HAHN -------------------------------------------------------------------------------- REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: LITRI DATE: 09/10/94 EXP: 05079 TALC TIME: 17:34:02 TEST: 02 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: RESPIRATORY EXPOSURE WHOLE NTP C#: 06008 CONT: CAS: 14807966 PATHOLOGIST: B. JONES F. HAHN TALC STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 736 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 49 UNCENSORED DEATHS 17 CENSORED DEATHS 2 TERMINAL 30 | | | | UNCENSORED DEATHS | | 8 423 432 437 484 486 518 543 571 579 | | 585 587 587 629 677 684 710 | | CENSORED DEATHS | | 20 691 | | | |--------------------------------------------------------------------------------| | DOSE = CONTROL LUNG TOX | | ---------------------------- | | | | TOTAL 39 UNCENSORED DEATHS 4 CENSORED DEATHS 24 TERMINAL 11 | | | | UNCENSORED DEATHS | | 39 295 619 715 | | CENSORED DEATHS | | 185 185 185 185 186 186 187 187 368 368 | | 369 369 369 369 369 369 549 549 549 549 | | 549 549 550 550 | | | |--------------------------------------------------------------------------------| | DOSE = 6 MG/M3 | | --------------------- | | | | TOTAL 49 UNCENSORED DEATHS 20 CENSORED DEATHS 1 TERMINAL 28 | | | | UNCENSORED DEATHS | | 253 253 320 344 423 546 550 558 584 590 | | 591 624 626 633 681 685 688 710 719 722 | | CENSORED DEATHS | | 62 | | | ================================================================================== TALC STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 736 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 6 MG/M3 LUNG TOX | | ---------------------------- | | | | TOTAL 40 UNCENSORED DEATHS 6 CENSORED DEATHS 25 TERMINAL 9 | | | | UNCENSORED DEATHS | | 376 554 617 672 676 718 | | CENSORED DEATHS | | 176 185 185 185 185 186 186 187 187 368 | | 368 369 369 369 369 369 369 549 549 549 | | 549 549 549 550 550 | | | |--------------------------------------------------------------------------------| | DOSE = 18 MG/M3 | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 1 TERMINAL 32 | | | | UNCENSORED DEATHS | | 28 114 115 159 422 438 457 478 538 541 | | 554 658 672 721 724 725 727 | | CENSORED DEATHS | | 622 | | | |--------------------------------------------------------------------------------| | DOSE = 18 MG/M3LUNG TOX | | ---------------------------- | | | | TOTAL 40 UNCENSORED DEATHS 8 CENSORED DEATHS 25 TERMINAL 7 | | | | UNCENSORED DEATHS | | 113 114 114 215 550 569 594 646 | | CENSORED DEATHS | | 148 185 185 186 186 186 186 187 187 368 | | 368 369 369 369 369 369 369 549 549 549 | | 549 549 549 550 550 | | | ================================================================================== TALC STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 736 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 736 (A) | | | |--------------------------------------------------------------------------------| | | | |CONTROL | 98.0 98.0 98.0 98.0 95.9 89.6 83.4 72.9 70.9 64.5 | | | | | | | |CONTROL | 97.4 97.4 97.4 94.2 94.2 94.2 94.2 94.2 86.9 79.7 | |LUNG TOX | | | | | |6 MG/M3 | 100.0 100.0 95.8 91.7 89.6 89.6 89.6 77.1 70.8 58.3 | | | | | | | |6 | 100.0 100.0 100.0 100.0 95.7 95.7 95.7 88.8 82.0 61.5 | |MG/M3 LUNG |OX | | | | |18 MG/M3 | 98.0 92.0 92.0 92.0 90.0 84.0 80.0 78.0 75.9 65.7 | | | | | | | |18 | 100.0 92.5 89.2 89.2 89.2 89.2 89.2 65.9 57.6 57.6 | |MG/M3LUNG T|X | | | | ================================================================================== TALC STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 736 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | CONTROL CONTROL 6 MG/M3 6 18 MG/M3 18 | | LUNG TOX MG/M3 LUNG TOX MG/M3LUNG TOX| |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 64.5% 79.7% 58.3% 61.5% 65.7% 57.6% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.636 ----- P=0.771 P=0.953N P=1.000N P=0.752 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 525.9 417.0 555.0 602.2 474.8 364.4 | |NATURAL DEATHS (C) | (38.7) ( 155) (34.3) (50.8) (57.5) (86.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 647.6 476.8 648.4 481.1 644.9 426.2 | |(STANDARD ERROR) | (23.4) (35.4) (22.4) (32.8) (26.0) (34.0) | | | | =============================================================================================================================== (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) TALC STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTOL | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 1 TERMINAL 30 | | | | UNCENSORED DEATHS | | 30 426 465 487 505 506 509 544 552 590 | | 598 641 647 669 680 683 686 692 723 | | CENSORED DEATHS | | 641 | | | |--------------------------------------------------------------------------------| | DOSE = CONTROL LUNG TOX | | ---------------------------- | | | | TOTAL 39 UNCENSORED DEATHS 9 CENSORED DEATHS 23 TERMINAL 7 | | | | UNCENSORED DEATHS | | 28 404 504 532 576 694 701 711 715 | | CENSORED DEATHS | | 185 185 186 186 186 186 187 187 368 368 | | 369 369 369 369 369 549 549 549 549 549 | | 549 550 550 | | | |--------------------------------------------------------------------------------| | DOSE = 6 MG/M3 | | --------------------- | | | | TOTAL 49 UNCENSORED DEATHS 25 CENSORED DEATHS 1 TERMINAL 23 | | | | UNCENSORED DEATHS | | 20 92 422 491 500 534 548 554 559 564 | | 618 621 628 641 645 665 676 678 686 692 | | 699 709 709 712 714 | | CENSORED DEATHS | | 622 | | | ================================================================================== TALC STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 6 MG/M3 LUNG TOX | | ---------------------------- | | | | TOTAL 40 UNCENSORED DEATHS 10 CENSORED DEATHS 24 TERMINAL 6 | | | | UNCENSORED DEATHS | | 4 17 453 523 617 655 659 678 697 717 | | CENSORED DEATHS | | 185 185 186 186 187 187 187 187 368 368 | | 369 369 369 369 369 369 549 549 549 549 | | 549 549 550 550 | | | |--------------------------------------------------------------------------------| | DOSE = 18 MG/M3 | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 25 CENSORED DEATHS 0 TERMINAL 25 | | | | UNCENSORED DEATHS | | 20 28 28 28 28 28 28 473 508 516 | | 548 554 558 569 581 642 646 655 661 665 | | 686 692 706 716 718 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 18 MG/M3LUNG TOX | | ---------------------------- | | | | TOTAL 40 UNCENSORED DEATHS 11 CENSORED DEATHS 24 TERMINAL 5 | | | | UNCENSORED DEATHS | | 28 28 28 28 114 286 495 508 546 604 | | 722 | | CENSORED DEATHS | | 185 185 186 186 187 187 187 187 368 368 | | 369 369 369 369 369 369 549 549 549 549 | | 549 549 550 550 | | | ================================================================================== TALC 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) | | | |--------------------------------------------------------------------------------| | | | |CONTOL | 98.0 98.0 98.0 98.0 98.0 94.0 84.0 78.0 73.9 61.6 | | | | | | | |CONTROL | 97.4 97.4 97.4 97.4 93.2 93.2 84.7 77.7 77.7 49.4 | |LUNG TOX | | | | | |6 MG/M3 | 98.0 95.9 95.9 95.9 93.9 93.9 87.8 79.6 67.1 48.2 | | | | | | | |6 | 95.0 95.0 95.0 95.0 95.0 90.7 86.4 86.4 64.8 43.2 | |MG/M3 LUNG |OX | | | | |18 MG/M3 | 86.0 86.0 86.0 86.0 86.0 84.0 80.0 70.0 60.0 50.0 | | | | | | | |18 | 90.0 87.5 87.5 84.3 84.3 84.3 74.9 60.2 60.2 50.2 | |MG/M3LUNG T|X | | | | ================================================================================== TALC STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | CONTOL CONTROL 6 MG/M3 6 18 MG/M3 18 | | LUNG TOX MG/M3 LUNG TOX MG/M3LUNG TOX| |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 61.6% 49.4% 48.2% 43.2% 50.0% 50.2% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.161 ----- P=0.322 P=0.441 P=0.286 P=0.211 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 559.6 540.6 575.1 502.0 451.3 307.9 | |NATURAL DEATHS (C) | (35.9) (73.9) (35.1) (85.8) (55.6) (82.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 662.9 472.6 648.3 455.7 590.1 396.7 | |(STANDARD ERROR) | (17.8) (33.6) (20.9) (34.4) (33.9) (35.2) | | | | =============================================================================================================================== (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) TALC KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 CONTROL LUNG TOX = 2 6 MG/M3 = 3 6 MG/M3 LUNG TOX = 4 18 MG/M3 = 5 18 MG/M3LUNG TOX = 6 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 5 2 6 3 4 | | 1 5 2 5 2 1 | 3 3 4 11 4 95 + | 5 5 2 3 3 11 2 | 6 5 6 5 | 3 3 1 1 90 + 3 5 3 | 6 64 4 P | 5 5 1 1 33 2 2 E | 5 5 R 85 + 1 133 C | 5 51 3 1 3 E | 556 6 4 4 N | 113 3 T 80 + 5 5 2 2 | 11 S | 5 3 3 5 U | 5 5 R 75 + 44 V | 6 6 5 5 I | 1 13 V | 13 13 55 A 70 + L | 11 4 | | 6 6 13 1 5 5 65 + 3 1 1 | | 33 | 4 4 60 + 33 | 3 3 | 6 6 | 55 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 10 obs hidden. TALC KAPLAN-MEIER SURVIVAL CURVES CONTOL = 1 CONTROL LUNG TOX = 2 6 MG/M3 = 3 6 MG/M3 LUNG TOX = 4 18 MG/M3 = 5 18 MG/M3LUNG TOX = 6 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 14 32 1 | 4 32 1 3 2 1 | 4 3 1 4 1 13 | 2 1321 P 90 + 6 6 4 2 423 E | 6 6 4 3 3 4 R | 5 6 5 6 1 2 113 2 C | 55 133 1 E 80 + 6 65 5 3 11 3 4 N | 55 2 1 1 2 T | 6 6 5 5 33 11 1 | 55 3 334 41 1 S 70 + 6 5 6 53 3 22 U | 55 3 3 R | 55 4 411 V | 331 22 1 1 I 60 + 6 5 33 6 V | 4533 22 A | 5 5 5 L | 50 + 4 26 2 | 3 3 | | 4 4 40 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 35 obs hidden.