TDMS Study 05150-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Mason METHLYPHENIDATE HYDROCHLORIDE DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 TIME: 09:27:46 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES65132 ROUTE: DOSED FEED NTP C#: 266 PATHOLOGIST: A. RUSSFIELD CAS: 298-59-9 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Mason METHLYPHENIDATE HYDROCHLORIDE DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 TIME: 09:27:46 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES65132 ROUTE: DOSED FEED NTP C#: 266 PATHOLOGIST: A. RUSSFIELD CAS: 298-59-9 METHLYPHENIDATE HYDROCHLORIDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 22 CENSORED DEATHS 20 TERMINAL 28 | | | | UNCENSORED DEATHS | | 304 391 459 524 549 550 566 594 612 632 | | 632 635 639 665 672 677 677 695 698 701 | | 715 717 | | CENSORED DEATHS | | 275 275 275 275 275 276 276 276 276 276 | | 462 462 462 462 462 463 463 463 463 463 | | | |--------------------------------------------------------------------------------| | DOSE = 100 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 16 CENSORED DEATHS 21 TERMINAL 33 | | | | UNCENSORED DEATHS | | 315 409 429 533 547 596 600 623 639 650 | | 650 675 676 687 717 724 | | CENSORED DEATHS | | 43 275 275 275 275 276 276 276 276 276 | | 276 462 462 462 463 463 463 463 463 463 | | 463 | | | |--------------------------------------------------------------------------------| | DOSE = 500 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 16 CENSORED DEATHS 20 TERMINAL 34 | | | | UNCENSORED DEATHS | | 325 383 406 542 566 624 638 653 674 676 | | 677 681 700 701 721 722 | | CENSORED DEATHS | | 275 275 275 275 275 275 276 276 276 276 | | 462 462 462 462 462 463 463 463 463 463 | | | ================================================================================== METHLYPHENIDATE HYDROCHLORIDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1000 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 17 CENSORED DEATHS 19 TERMINAL 34 | | | | UNCENSORED DEATHS | | 180 185 187 357 386 439 518 590 598 639 | | 653 675 678 682 682 686 722 | | CENSORED DEATHS | | 275 275 275 275 276 276 276 276 276 462 | | 462 462 462 462 462 462 463 463 463 | | | ================================================================================== METHLYPHENIDATE HYDROCHLORIDE 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 98.3 96.7 95.0 93.0 84.9 72.8 56.6 | | | | | | | |100 PPM | 100.0 100.0 100.0 98.3 96.6 94.9 92.9 86.7 78.4 68.1 | | | | | | | |500 PPM | 100.0 100.0 100.0 98.3 95.0 95.0 93.0 91.0 84.9 68.7 | | | | | | | |1000 PPM | 100.0 98.6 95.7 94.1 92.4 90.8 88.7 84.7 80.7 68.6 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 100 PPM 500 PPM 1000 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 56.6% 68.1% 68.7% 68.6% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.529N P=0.344N P=0.257N P=0.426N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 604.7 591.9 605.6 521.0 | |NATURAL DEATHS (C) | (23.0) (29.5) (31.8) (47.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 587.1 585.0 597.9 582.1 | |(STANDARD ERROR) | (20.0) (21.8) (20.6) (22.2) | | | | ================================================================================== (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) METHLYPHENIDATE HYDROCHLORIDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 737 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 19 CENSORED DEATHS 20 TERMINAL 31 | | | | UNCENSORED DEATHS | | 260 450 551 563 575 613 648 649 650 660 | | 660 662 668 675 677 680 684 728 729 | | CENSORED DEATHS | | 281 281 281 281 282 282 282 282 282 282 | | 463 463 463 463 463 463 464 464 464 464 | | | |--------------------------------------------------------------------------------| | DOSE = 100 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 18 CENSORED DEATHS 20 TERMINAL 32 | | | | UNCENSORED DEATHS | | 450 488 494 579 619 632 660 671 681 685 | | 699 712 713 718 720 721 728 729 | | CENSORED DEATHS | | 281 281 281 281 281 282 282 282 282 282 | | 463 463 463 464 464 464 464 464 464 464 | | | |--------------------------------------------------------------------------------| | DOSE = 500 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 14 CENSORED DEATHS 20 TERMINAL 36 | | | | UNCENSORED DEATHS | | 288 425 466 539 546 567 588 638 646 675 | | 675 688 730 730 | | CENSORED DEATHS | | 281 281 281 281 281 281 282 282 282 282 | | 463 463 463 463 463 464 464 464 464 464 | | | ================================================================================== METHLYPHENIDATE HYDROCHLORIDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 737 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1000 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 11 CENSORED DEATHS 20 TERMINAL 39 | | | | UNCENSORED DEATHS | | 404 442 530 559 591 619 637 658 669 676 | | 714 | | CENSORED DEATHS | | 281 281 281 281 281 282 282 282 282 282 | | 463 463 463 463 463 463 464 464 464 464 | | | ================================================================================== METHLYPHENIDATE HYDROCHLORIDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 737 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 737 (A) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 100.0 100.0 98.6 98.6 98.6 96.9 96.9 90.8 76.7 62.6 | | | | | | | |100 PPM | 100.0 100.0 100.0 100.0 100.0 98.3 94.3 92.3 86.3 64.2 | | | | | | | |500 PPM | 100.0 100.0 100.0 98.3 96.7 94.7 92.6 86.6 82.6 72.5 | | | | | | | |1000 PPM | 100.0 100.0 100.0 100.0 98.3 96.7 94.7 90.6 84.6 78.5 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 100 PPM 500 PPM 1000 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 62.6% 64.2% 72.5% 78.5% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.096N P=0.818N P=0.426N P=0.154N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 620.1 649.9 585.8 590.8 | |NATURAL DEATHS (C) | (25.1) (21.1) (33.8) (29.8) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 601.1 610.5 602.6 609.9 | |(STANDARD ERROR) | (20.4) (20.2) (20.8) (20.5) | | | | ================================================================================== (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) METHLYPHENIDATE HYDROCHLORIDE KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 100 PPM = 2 500 PPM = 3 1000 PPM = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 1 2 3 | 44 1 2 3 31 2 | | 4 4 31 32 2 1 95 + 3 2 1 1 23 | 4 4 | 4 4 1 231 3 | 4 4 2 3 2 3 90 + | 4 1 1 4 3 3 P | 1 1 3 3 E | 42 2 R 85 + 14 12 2 3 3 C | E | 1 1224 N | 4 4 T 80 + | 2 23 S | U | 11 43 3 R 75 + 1 1 33 V | 2 2 I | 11 2 3 2 V | 11 33 A 70 + 4 22 L | 3 3 | 2 2 | 1 1 65 + | | 11 | 1 1 60 + | | | 1 1 55 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 13 obs hidden. METHLYPHENIDATE HYDROCHLORIDE KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 100 PPM = 2 500 PPM = 3 1000 PPM = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 3 4 2 | 1 3 4 3 4 1 2 | 1 1 | 3 4 3 22 4 95 + 3 43 141 | 2 2 | 33 41 1 4 2 | 3 3 1 4 14 P 90 + 2 2 E | 3 3 14 2 1 2 R | C | 3 43 4 22 E 85 + 334 4 N | 2 2 T | 1 143 | S 80 + 42 2 4 U | 3 32 2 4 R | V | 11 3 3 I 75 + 11 V | 22 A | 33 L | 11 70 + | 22 | | 1 1 2 65 + 1 1 | 22 | 11 | 60 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 10 obs hidden.