TDMS Study 05150-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Mason METHYLPHENIDATE HYDROCHLORIDE DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 TIME: 10:17:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-65132 ROUTE: DOSED FEED NTP C#: 56280B 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 METHYLPHENIDATE HYDROCHLORIDE DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 TIME: 10:17:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-65132 ROUTE: DOSED FEED NTP C#: 56280B PATHOLOGIST: A. RUSSFIELD CAS: 298-59-9 METHYLPHENIDATE HYDROCHLORIDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 5 CENSORED DEATHS 20 TERMINAL 45 | | | | UNCENSORED DEATHS | | 537 617 639 640 679 | | CENSORED DEATHS | | 274 274 274 274 275 275 275 275 275 275 | | 454 454 454 454 454 454 455 455 455 455 | | | |--------------------------------------------------------------------------------| | DOSE = 50 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 5 CENSORED DEATHS 20 TERMINAL 45 | | | | UNCENSORED DEATHS | | 628 674 707 708 720 | | CENSORED DEATHS | | 274 274 274 274 274 274 274 274 275 275 | | 454 454 454 455 455 455 455 455 455 455 | | | |--------------------------------------------------------------------------------| | DOSE = 250 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 6 CENSORED DEATHS 20 TERMINAL 44 | | | | UNCENSORED DEATHS | | 541 585 601 610 626 710 | | CENSORED DEATHS | | 274 274 274 274 274 274 275 275 275 275 | | 454 454 454 454 454 454 455 455 455 455 | | | ================================================================================== METHYLPHENIDATE HYDROCHLORIDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 500 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 9 CENSORED DEATHS 20 TERMINAL 41 | | | | UNCENSORED DEATHS | | 574 618 626 647 654 684 687 700 707 | | CENSORED DEATHS | | 274 274 275 275 275 275 275 275 275 275 | | 454 454 454 454 454 455 455 455 455 455 | | | ================================================================================== METHYLPHENIDATE HYDROCHLORIDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 730 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 730 (A) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 98.0 92.0 90.0 | | | | | | | |50 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 98.0 90.0 | | | | | | | |250 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 94.0 90.0 88.0 | | | | | | | |500 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 98.0 90.0 82.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 50 PPM 250 PPM 500 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 90.0% 90.0% 88.0% 82.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.219 P=1.000N P=0.967 P=0.414 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 622.4 687.4 612.2 655.2 | |NATURAL DEATHS (C) | (23.6) (16.7) (22.9) (14.6) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 617.9 622.5 615.4 616.0 | |(STANDARD ERROR) | (20.5) (20.6) (20.4) (20.3) | | | | ================================================================================== (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) METHYLPHENIDATE HYDROCHLORIDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 739 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 69 UNCENSORED DEATHS 11 CENSORED DEATHS 21 TERMINAL 37 | | | | UNCENSORED DEATHS | | 67 571 581 621 628 673 684 685 708 708 | | 708 | | CENSORED DEATHS | | 280 280 280 280 280 280 281 281 281 281 | | 348 455 455 455 455 455 456 456 456 456 | | 456 | | | |--------------------------------------------------------------------------------| | DOSE = 50 PPM | | --------------------- | | | | TOTAL 69 UNCENSORED DEATHS 14 CENSORED DEATHS 20 TERMINAL 35 | | | | UNCENSORED DEATHS | | 103 145 158 391 462 588 603 625 628 681 | | 690 690 699 730 | | CENSORED DEATHS | | 12 280 280 280 281 281 281 281 281 281 | | 455 455 455 455 455 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 250 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 13 CENSORED DEATHS 20 TERMINAL 37 | | | | UNCENSORED DEATHS | | 57 183 469 578 607 656 686 689 697 705 | | 708 719 728 | | CENSORED DEATHS | | 280 280 280 280 280 281 281 281 281 281 | | 455 455 455 455 455 455 456 456 456 456 | | | ================================================================================== METHYLPHENIDATE HYDROCHLORIDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 739 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 500 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 6 CENSORED DEATHS 20 TERMINAL 44 | | | | UNCENSORED DEATHS | | 648 660 660 677 690 695 | | CENSORED DEATHS | | 280 280 280 280 280 280 281 281 281 281 | | 455 455 455 455 456 456 456 456 456 456 | | | ================================================================================== METHYLPHENIDATE HYDROCHLORIDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 739 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 739 (A) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 98.6 98.6 98.6 98.6 98.6 98.6 98.6 94.4 90.2 77.6 | | | | | | | |50 PPM | 100.0 95.6 95.6 95.6 93.9 91.8 91.8 87.6 83.5 73.0 | | | | | | | |250 PPM | 98.6 98.6 97.1 97.1 97.1 95.1 95.1 93.1 89.0 74.9 | | | | | | | |500 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 94.0 88.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 50 PPM 250 PPM 500 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 77.6% 73.0% 74.9% 88.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.102N P=0.597 P=0.888 P=0.235N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 603.1 513.8 575.5 671.7 | |NATURAL DEATHS (C) | (55.7) (60.2) (59.9) ( 7.6) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 604.1 581.9 602.6 627.2 | |(STANDARD ERROR) | (22.4) (24.8) (22.8) (20.7) | | | | ================================================================================== (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) METHYLPHENIDATE HYDROCHLORIDE KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 50 PPM = 2 250 PPM = 3 500 PPM = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 13 4 2 | | | 98 + 13 4 3 12 2 | | | 96 + 3 3 14 1 2 2 | P | E | R 94 + 3 3 4 4 22 C | E | N | T 92 + 3 3 144 1 22 | S | U | R 90 + 3 4 14 32 1 V | I | V | A 88 + 44 3 3 L | | | 86 + 44 | | | 84 + 44 | | | 82 + 4 4 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 6 obs hidden. METHYLPHENIDATE HYDROCHLORIDE KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 50 PPM = 2 250 PPM = 3 500 PPM = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 31 2 4 | 31 2 2 3 1 | 2 2 3 3 4 4 | 11 P 95 + 2 2 3 3 E | 2 2 1 1 4 4 R | 3 3 11 4 4 C | 2 2 3 3 E 90 + 2 2 1 1 44 N | 3 3 T | 2 2 1134 4 | S 85 + 33 U | 2 1 1 R | 33 V | 22 33 I 80 + V | 33 A | 22 133 1 L | 75 + 2 3 23 | | 22 | 70 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 5 obs hidden.