TDMS Study 05084-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Mason DATE: 09/10/94 EXP: 05084 TURMERIC OLEORESIN TIME: 21:56:47 TEST: 01 CAGES FROM 0000 TO LAST CAGE PAGE: 1 TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 60015 CONT: N01ES9561902 CAS: 458-37-7 PATHOLOGIST: R. FLEISCHMAN -------------------------------------------------------------------------------- REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Mason DATE: 09/10/94 EXP: 05084 TURMERIC OLEORESIN TIME: 21:56:47 TEST: 01 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 60015 CONT: N01ES9561902 CAS: 458-37-7 PATHOLOGIST: R. FLEISCHMAN TURMERIC OLEORESIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 32 CENSORED DEATHS 10 TERMINAL 18 | | | | UNCENSORED DEATHS | | 404 435 465 494 505 521 521 529 531 543 | | 543 553 563 567 589 609 633 634 644 655 | | 662 671 676 687 695 695 696 696 711 715 | | 718 722 | | CENSORED DEATHS | | 456 456 456 459 459 459 459 459 459 459 | | | |--------------------------------------------------------------------------------| | DOSE = 2,000PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 33 CENSORED DEATHS 10 TERMINAL 17 | | | | UNCENSORED DEATHS | | 337 519 534 549 582 583 588 602 606 611 | | 612 648 652 658 658 660 683 690 690 696 | | 696 703 703 704 707 710 715 718 718 721 | | 722 722 723 | | CENSORED DEATHS | | 456 456 456 456 456 459 459 459 459 459 | | | |--------------------------------------------------------------------------------| | DOSE = 10,000 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 35 CENSORED DEATHS 10 TERMINAL 15 | | | | UNCENSORED DEATHS | | 141 199 337 464 467 499 532 539 556 568 | | 579 585 594 612 634 645 648 653 654 661 | | 662 667 674 676 682 682 687 695 697 703 | | 707 715 715 722 722 | | CENSORED DEATHS | | 456 456 456 456 456 459 459 459 459 459 | | | ================================================================================== TURMERIC OLEORESIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 50,000 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 34 CENSORED DEATHS 9 TERMINAL 17 | | | | UNCENSORED DEATHS | | 270 367 368 371 374 400 404 414 456 479 | | 487 492 504 521 521 522 522 528 538 569 | | 580 610 615 633 640 669 673 676 682 682 | | 695 695 711 716 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 459 459 | | | ================================================================================== TURMERIC OLEORESIN 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 | 100.0 100.0 100.0 100.0 98.3 94.7 78.5 70.5 58.4 36.2 | | | | | | | |2,000PPM | 100.0 100.0 100.0 98.3 98.3 98.3 94.3 84.3 68.2 34.1 | | | | | | | |10,000 PPM| 100.0 98.3 96.7 95.0 95.0 91.0 84.9 74.8 58.6 30.3 | | | | | | | |50,000 PPM| 100.0 100.0 98.3 98.3 86.7 83.0 64.8 60.7 52.6 34.4 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 2,000PPM 10,000 PPM 50,000 P|M | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 36.2% 34.1% 30.3% 34.4% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.258 P=0.707N P=0.778 P=0.440 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 602.6 649.1 599.2 540.7 | |NATURAL DEATHS (C) | (16.1) (14.3) (23.4) (21.0) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 616.4 639.8 608.1 581.5 | |(STANDARD ERROR) | (14.5) (13.9) (17.6) (17.3) | | | | ================================================================================== (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) TURMERIC OLEORESIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 727 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 17 CENSORED DEATHS 10 TERMINAL 33 | | | | UNCENSORED DEATHS | | 461 468 517 517 550 553 574 603 643 643 | | 646 676 680 681 692 707 717 | | CENSORED DEATHS | | 455 455 455 455 457 457 457 457 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 2,000PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 23 CENSORED DEATHS 10 TERMINAL 27 | | | | UNCENSORED DEATHS | | 444 506 552 552 560 591 595 598 615 622 | | 647 654 667 685 694 700 700 700 700 700 | | 702 702 702 | | CENSORED DEATHS | | 455 455 455 455 457 457 457 457 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 10,000 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 22 CENSORED DEATHS 10 TERMINAL 28 | | | | UNCENSORED DEATHS | | 414 455 456 462 489 519 526 528 556 576 | | 577 591 643 647 655 677 680 688 700 700 | | 708 708 | | CENSORED DEATHS | | 455 455 455 455 455 455 455 455 455 457 | | | ================================================================================== TURMERIC OLEORESIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 727 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 50,000 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 17 CENSORED DEATHS 9 TERMINAL 34 | | | | UNCENSORED DEATHS | | 311 359 367 493 510 518 528 598 624 632 | | 659 661 673 673 700 708 721 | | CENSORED DEATHS | | 455 455 455 457 457 457 457 457 457 | | | ================================================================================== TURMERIC OLEORESIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 727 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 727 (A) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 100.0 100.0 100.0 100.0 100.0 96.0 92.0 84.0 78.0 66.0 | | | | | | | |2,000PPM | 100.0 100.0 100.0 100.0 100.0 98.3 96.3 84.3 76.3 54.2 | | | | | | | |10,000 PPM| 100.0 100.0 100.0 100.0 98.3 92.7 84.6 76.6 70.5 56.4 | | | | | | | |50,000 PPM| 100.0 100.0 100.0 96.7 95.0 95.0 87.1 85.1 77.2 67.3 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 2,000PPM 10,000 PPM 50,000 P|M | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 66.0% 54.2% 56.4% 67.3% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.549N P=0.391 P=0.366 P=1.000 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 607.5 634.3 588.9 572.6 | |NATURAL DEATHS (C) | (20.4) (15.4) (20.6) (31.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 648.0 646.3 631.1 642.7 | |(STANDARD ERROR) | (14.2) (13.7) (15.1) (16.0) | | | | ================================================================================== (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) TURMERIC OLEORESIN KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 2,000PPM = 2 10,000 PPM = 3 50,000 PPM = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 3 4 2 1 | 3 3 4 2 4 1 1 1 2 2 | 3 1 1 2 2 | 44 4 1 1 2 2 90 + 3 31 13 | 4 4 4 113 2 2 P | 4 4 3 3 22 E | 44 1 1 3 3 22 R 80 + 444 333 C | 4 4 11 1 3 3 2 22 E | 3 3 N | 1 1 3 3 T 70 + 44 1 1 3 32 2 | 44 1 1 33 2 2 S | 4 4 11 22 U | 44 1 1 3 22 R 60 + 4 4 1 1 V | 4 4 111 22 I | 44 1 1 V | 4 43311 A 50 + 44 22 L | 4333 22 | 1 1 | 4 3311 40 + 22 | 43411 1 | 32 2 | 30 + 3 3 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 32 obs hidden. TURMERIC OLEORESIN KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 2,000PPM = 2 10,000 PPM = 3 50,000 PPM = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 4 3 2 1 | 4 4 3 2 3 2 | 11 | 44 331 21 2 95 + 4 4 | | 3 34 41 12 | 3 44 3 90 + 2 2 | 4 33 | 4 1 1 4 | 1 221 P 85 + 3 3 4 4 E | 212 441 R | 3 3 22 C | 4 4 E 80 + 2 11 N | 3 3 22 T | 1 4 1 | 3 3 2 211 S 75 + 33 U | 242 4 R | 33 112 V | 4 4 I 70 + 3 3 1 1 V | 33 44 A | 1 14 L | 33 11 65 + 33 | | | 60 + 223 | | | 3 3 55 + | 2 2 | | 50 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 10 obs hidden.