TDMS Study 05019-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst DATE: 09/03/94 EXP: 05019 CI PIGMENT RED 3 TIME: 16:44:27 TEST: 04 CAGES FROM 0000 TO LAST CAGE PAGE: 1 TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 60366 CONT: NOIES9565102 CAS: 2425-85-6 PATHOLOGIST: H. GILES S. EUSTIS -------------------------------------------------------------------------------- REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst DATE: 09/03/94 EXP: 05019 CI PIGMENT RED 3 TIME: 16:44:27 TEST: 04 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 60366 CONT: NOIES9565102 CAS: 2425-85-6 PATHOLOGIST: H. GILES S. EUSTIS CI PIGMENT RED 3 STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = UNTREATD CONTROL | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 17 CENSORED DEATHS 10 TERMINAL 33 | | | | UNCENSORED DEATHS | | 151 240 291 324 416 450 489 583 599 630 | | 653 680 681 681 697 700 724 | | CENSORED DEATHS | | 456 456 456 456 457 457 457 457 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 1.25% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 22 CENSORED DEATHS 10 TERMINAL 28 | | | | UNCENSORED DEATHS | | 56 180 228 283 295 316 322 336 388 402 | | 484 512 576 588 648 650 653 653 679 703 | | 704 710 | | CENSORED DEATHS | | 456 456 456 456 457 457 457 457 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 2.5% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 20 CENSORED DEATHS 9 TERMINAL 31 | | | | UNCENSORED DEATHS | | 85 221 279 295 372 430 469 521 541 553 | | 556 570 642 658 662 697 697 703 704 724 | | CENSORED DEATHS | | 456 456 456 456 456 456 457 457 457 | | | ================================================================================== CI PIGMENT RED 3 STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 5.0% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 19 CENSORED DEATHS 8 TERMINAL 33 | | | | UNCENSORED DEATHS | | 84 210 231 280 289 294 301 323 325 326 | | 454 555 557 557 557 557 567 578 665 | | CENSORED DEATHS | | 456 456 456 456 457 457 457 457 | | | ================================================================================== CI PIGMENT RED 3 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) | | | |--------------------------------------------------------------------------------| | | | |UNTREATD | 100.0 98.3 96.7 93.3 91.7 90.0 88.0 83.9 79.8 67.5 | |CONTROL | | | | | |1.25% | 98.3 96.7 95.0 86.7 83.3 81.2 79.2 75.0 66.7 58.3 | | | | | | | |2.5% | 98.3 98.3 96.7 93.3 91.7 88.0 84.0 78.0 72.0 62.0 | | | | | | | |5.0% | 98.3 98.3 95.0 83.3 83.3 81.7 81.7 67.7 65.7 65.7 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | UNTREATD 1.25% 2.5% 5.0% | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 67.5% 58.3% 62.0% 65.7% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.817 P=0.330 P=0.684 P=0.662 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 528.8 471.2 519.0 405.8 | |NATURAL DEATHS (C) | (44.7) (42.2) (41.4) (37.6) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 626.9 589.1 618.1 590.3 | |(STANDARD ERROR) | (19.5) (22.9) (20.3) (23.2) | | | | ================================================================================== (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) CI PIGMENT RED 3 STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = UNTREATD CONTROL | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 10 CENSORED DEATHS 11 TERMINAL 39 | | | | UNCENSORED DEATHS | | 326 508 528 630 653 680 691 703 719 724 | | CENSORED DEATHS | | 4 4 458 458 458 458 458 459 459 459 | | 459 | | | |--------------------------------------------------------------------------------| | DOSE = 1.25% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 13 CENSORED DEATHS 10 TERMINAL 37 | | | | UNCENSORED DEATHS | | 337 540 561 568 599 599 627 653 653 680 | | 696 719 724 | | CENSORED DEATHS | | 458 458 458 458 458 458 459 459 459 459 | | | |--------------------------------------------------------------------------------| | DOSE = 2.5% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 19 CENSORED DEATHS 10 TERMINAL 31 | | | | UNCENSORED DEATHS | | 474 497 542 547 568 595 597 606 613 616 | | 627 670 676 679 696 696 709 724 724 | | CENSORED DEATHS | | 458 458 458 458 458 459 459 459 459 459 | | | ================================================================================== CI PIGMENT RED 3 STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 5.0% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 25 CENSORED DEATHS 10 TERMINAL 25 | | | | UNCENSORED DEATHS | | 286 358 540 557 557 588 588 599 599 603 | | 616 618 625 625 625 625 625 627 627 627 | | 627 680 680 707 717 | | CENSORED DEATHS | | 458 458 458 458 459 459 459 459 459 459 | | | ================================================================================== CI PIGMENT RED 3 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) | | | |--------------------------------------------------------------------------------| | | | |UNTREATD | 100.0 100.0 100.0 98.3 98.3 98.3 94.2 94.2 90.1 79.8 | |CONTROL | | | | | |1.25% | 100.0 100.0 100.0 98.3 98.3 98.3 96.3 88.3 82.3 74.3 | | | | | | | |2.5% | 100.0 100.0 100.0 100.0 100.0 98.0 94.0 86.0 78.0 62.0 | | | | | | | |5.0% | 100.0 100.0 100.0 96.7 96.7 96.7 94.7 80.6 58.4 50.3 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | UNTREATD 1.25% 2.5% 5.0% | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 79.8% 74.3% 62.0% 50.3% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P=0.637 P=0.078 P=0.002 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 616.2 612.0 624.0 597.0 | |NATURAL DEATHS (C) | (40.1) (28.3) (17.3) (18.7) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 645.5 658.6 650.7 629.0 | |(STANDARD ERROR) | (21.0) (14.4) (13.8) (14.8) | | | | ================================================================================== (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) CI PIGMENT RED 3 KAPLAN-MEIER SURVIVAL CURVES UNTREATD CONTROL = 1 1.25% = 2 2.5% = 3 5.0% = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 2 43 1 | 2 43 1 2 4 3 1 | | 2 4 32 1 3 1 95 + 2 3213 1 | 4242 1 3 1 | | 2 2 3 1 3 1 90 + 44 3 1 3 1 | 4 242 P | 3 1 3 1 E | 2 2 3 3 1 1 R 85 + 2 2 C | 4 2 4 2 33 1 1 E | 33 N | 4 2 2 4 1 1 T 80 + 3 3 1 1 | 2 2 S | 322 3 U | 3 3 R 75 + 2 2 V | 3 3 1 1 I | 3 3 V | 44 22 A 70 + 4 4 1 1 L | | 4 4 33 1 1 | 2 4 2 4 65 + 2 2 | 3 3 | 3 3 | 60 + 22 | 2 2 | | 55 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 7 obs hidden. CI PIGMENT RED 3 KAPLAN-MEIER SURVIVAL CURVES UNTREATD CONTROL = 1 1.25% = 2 2.5% = 3 5.0% = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 4 1 2 3 | 4 1 2 4 1 2 | 3 3 | 4 3 1 1 2 2 95 + 4 4 | 1 33 22 1 | 3 2 2 1 1 | 4 4 90 + 3 3 1 1 | 2 2 | 33 11 | 4 33 2 2 1 1 P 85 + E | 33 1 1 R | 44 2 2 11 C | E 80 + 43 3 2 2 1 1 N | 44 2 2 T | 3 3 | 44 33 22 S 75 + U | 2 2 R | 3 3 V | I 70 + V | A | 3 3 L | 3 3 65 + | | 3 3 | 60 + | 4 4 | | 55 + 4 4 | | 4 4 | 50 + 4 4 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 8 obs hidden. --multipart-boundary Content-type: text/plain Range: bytes 29721-29721/29721 --multipart-boundary--