TDMS Study 05084-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Mason DATE: 09/11/94 EXP: 05084 TURMERIC OLEORESIN TIME: 00:39:14 TEST: 02 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: 09/11/94 EXP: 05084 TURMERIC OLEORESIN TIME: 00:39:14 TEST: 02 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 MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 7 CENSORED DEATHS 10 TERMINAL 43 | | | | UNCENSORED DEATHS | | 159 479 609 618 634 664 717 | | CENSORED DEATHS | | 455 455 455 455 455 457 457 457 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 2,000PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 7 CENSORED DEATHS 10 TERMINAL 43 | | | | UNCENSORED DEATHS | | 507 542 661 679 691 693 715 | | CENSORED DEATHS | | 455 455 455 455 455 455 455 457 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 10,000 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 13 CENSORED DEATHS 10 TERMINAL 37 | | | | UNCENSORED DEATHS | | 224 399 541 541 595 639 640 647 708 713 | | 713 716 725 | | CENSORED DEATHS | | 455 455 455 455 457 457 457 457 457 457 | | | ================================================================================== TURMERIC OLEORESIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 50,000 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 8 CENSORED DEATHS 10 TERMINAL 42 | | | | UNCENSORED DEATHS | | 437 537 598 627 678 680 724 724 | | CENSORED DEATHS | | 455 455 455 455 457 457 457 457 457 457 | | | ================================================================================== TURMERIC OLEORESIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE 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 PPM | 100.0 98.3 98.3 98.3 98.3 96.3 96.3 96.3 88.3 86.3 | | | | | | | |2,000PPM | 100.0 100.0 100.0 100.0 100.0 100.0 96.0 96.0 94.0 86.0 | | | | | | | |10,000 PPM| 100.0 100.0 98.3 98.3 96.7 96.7 92.6 90.6 84.6 74.5 | | | | | | | |50,000 PPM| 100.0 100.0 100.0 100.0 100.0 98.3 96.3 94.3 92.3 84.3 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 2,000PPM 10,000 PPM 50,000 P|M | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 86.3% 86.0% 74.5% 84.3% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=1.000N P=1.000N P=0.223 P=1.000 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 554.3 641.1 600.1 625.6 | |NATURAL DEATHS (C) | (71.4) (31.0) (40.9) (35.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 663.1 673.2 655.6 669.8 | |(STANDARD ERROR) | (16.1) (13.6) (15.9) (13.9) | | | | ================================================================================== (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 MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 10 CENSORED DEATHS 11 TERMINAL 39 | | | | UNCENSORED DEATHS | | 515 522 536 586 628 673 681 701 703 703 | | CENSORED DEATHS | | 84 450 450 450 450 450 450 450 453 453 | | 453 | | | |--------------------------------------------------------------------------------| | DOSE = 2,000PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 9 CENSORED DEATHS 10 TERMINAL 41 | | | | UNCENSORED DEATHS | | 206 281 467 552 599 666 681 701 718 | | CENSORED DEATHS | | 450 450 450 450 453 453 453 453 453 453 | | | |--------------------------------------------------------------------------------| | DOSE = 10,000 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 17 CENSORED DEATHS 9 TERMINAL 34 | | | | UNCENSORED DEATHS | | 6 9 13 400 437 524 534 609 662 667 | | 667 677 703 704 705 714 721 | | CENSORED DEATHS | | 450 450 450 450 450 450 453 453 453 | | | ================================================================================== TURMERIC OLEORESIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 50,000 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 8 CENSORED DEATHS 10 TERMINAL 42 | | | | UNCENSORED DEATHS | | 233 449 621 662 667 701 703 703 | | CENSORED DEATHS | | 450 450 450 453 453 453 453 453 453 453 | | | ================================================================================== TURMERIC OLEORESIN 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 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 93.9 91.8 89.8 79.6 | | | | | | | |2,000PPM | 100.0 100.0 98.3 96.7 96.7 94.7 94.7 90.6 90.6 82.6 | | | | | | | |10,000 PPM| 95.0 95.0 95.0 95.0 93.3 91.7 87.7 87.7 83.7 67.8 | | | | | | | |50,000 PPM| 100.0 100.0 98.3 98.3 98.3 96.7 96.7 96.7 92.6 84.6 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 2,000PPM 10,000 PPM 50,000 P|M | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 79.6% 82.6% 67.8% 84.6% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.505N P=0.980N P=0.198 P=0.743N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 624.8 541.2 514.8 592.4 | |NATURAL DEATHS (C) | (24.8) (62.5) (63.0) (59.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 654.5 654.6 626.6 664.6 | |(STANDARD ERROR) | (17.0) (17.1) (23.3) (15.6) | | | | ================================================================================== (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=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 3 4 2 | 1 3 3 4 1 4 | 2 2 | 3 1 42 41 2 P 95 + E | 41 14 2 2 R | 3 3 141 2 2 C | 3 3 E 90 + 1 1 44 N | 1 4 14 T | 2 2 | 33 1 1 S 85 + 3 3 U | 4 4 R | V | I 80 + V | 33 A | L | 33 75 + 3 3 | | | 70 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 7 obs hidden. TURMERIC OLEORESIN KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 2,000PPM = 2 10,000 PPM = 3 50,000 PPM = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 13 2 4 1 | 33 2 4 2 4 | 1 1 | 2 4 2 1 1 4 95 + 3 3 2 2 4 4 | 3 3 1 1 P | 2 2 44 E | 3 3 1 2 1 2 4 R 90 + 3 3 1 1 C | 2 2 E | 3 3 11 N | 3 3 1 1 T 85 + 2 2 4 | 33 S | 2 2 U | R 80 + 33 1 1 V | I | 3 3 V | A 75 + L | | | 33 70 + 33 | | 3 3 | 65 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 7 obs hidden.