TDMS Study 05021-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst DATE: 09/03/94 EXP: 05021 CI PIGMENT RED 23 TIME: 23:16:43 TEST: 04 CAGES FROM 0000 TO LAST CAGE PAGE: 1 TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 60377 CONT: N01ES9565102 CAS: 6471-49-4 PATHOLOGIST: S. EUSTIS J. SEALY -------------------------------------------------------------------------------- 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: 05021 CI PIGMENT RED 23 TIME: 23:16:43 TEST: 04 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 60377 CONT: N01ES9565102 CAS: 6471-49-4 PATHOLOGIST: S. EUSTIS J. SEALY CI PIGMENT RED 23 STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 723 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = UNTREATD CONTROL | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 22 CENSORED DEATHS 9 TERMINAL 29 | | | | UNCENSORED DEATHS | | 27 140 364 418 455 463 511 518 536 604 | | 610 618 644 644 644 644 647 647 687 694 | | 711 722 | | CENSORED DEATHS | | 361 463 463 463 464 464 464 464 464 | | | |--------------------------------------------------------------------------------| | DOSE = 1.0% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 36 CENSORED DEATHS 7 TERMINAL 17 | | | | UNCENSORED DEATHS | | 35 73 79 85 87 115 122 125 168 189 | | 258 327 380 388 421 422 436 472 515 524 | | 581 598 603 617 644 647 648 673 687 719 | | 721 721 721 722 722 722 | | CENSORED DEATHS | | 463 463 463 464 464 464 464 | | | |--------------------------------------------------------------------------------| | DOSE = 2.5% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 25 CENSORED DEATHS 8 TERMINAL 27 | | | | UNCENSORED DEATHS | | 87 87 87 207 339 393 452 505 520 529 | | 583 585 590 603 617 618 622 647 647 648 | | 648 687 719 721 721 | | CENSORED DEATHS | | 463 463 463 463 463 463 464 464 | | | ================================================================================== CI PIGMENT RED 23 STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 723 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 5.0% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 21 CENSORED DEATHS 9 TERMINAL 30 | | | | UNCENSORED DEATHS | | 151 408 469 542 559 571 596 603 606 638 | | 647 648 648 648 672 672 672 672 672 673 | | 700 | | CENSORED DEATHS | | 463 463 463 464 464 464 464 464 464 | | | ================================================================================== CI PIGMENT RED 23 STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 723 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 723 (A) | | | |--------------------------------------------------------------------------------| | | | |UNTREATD | 98.3 96.7 96.7 95.0 93.3 89.9 83.9 81.9 65.9 57.9 | |CONTROL | | | | | |1.0% | 91.7 85.0 81.7 80.0 73.3 69.7 65.7 59.7 51.8 33.8 | | | | | | | |2.5% | 95.0 95.0 93.3 91.7 90.0 88.3 82.4 74.6 60.9 53.0 | | | | | | | |5.0% | 100.0 98.3 98.3 98.3 96.7 94.7 92.7 84.8 73.0 59.2 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | UNTREATD 1.0% 2.5% 5.0% | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 57.9% 33.8% 53.0% 59.2% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.177N P=0.010 P=0.678 P=0.819N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 543.1 443.5 514.5 593.7 | |NATURAL DEATHS (C) | (38.1) (40.7) (40.3) (27.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 616.4 525.1 601.5 638.8 | |(STANDARD ERROR) | (19.7) (29.2) (22.0) (15.4) | | | | ================================================================================== (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 23 STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 723 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = UNTREATD CONTROL | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 15 CENSORED DEATHS 10 TERMINAL 35 | | | | UNCENSORED DEATHS | | 501 559 585 603 610 616 618 634 655 655 | | 661 673 687 694 710 | | CENSORED DEATHS | | 465 465 465 465 465 466 466 466 466 466 | | | |--------------------------------------------------------------------------------| | DOSE = 1.0% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 15 CENSORED DEATHS 11 TERMINAL 34 | | | | UNCENSORED DEATHS | | 77 80 420 445 487 516 571 613 619 647 | | 665 683 703 710 722 | | CENSORED DEATHS | | 465 465 465 465 465 465 465 466 466 466 | | 469 | | | |--------------------------------------------------------------------------------| | DOSE = 2.5% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 14 CENSORED DEATHS 10 TERMINAL 36 | | | | UNCENSORED DEATHS | | 452 472 516 521 585 606 631 645 661 667 | | 707 710 721 721 | | CENSORED DEATHS | | 465 465 465 465 465 466 466 466 466 470 | | | ================================================================================== CI PIGMENT RED 23 STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 723 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 5.0% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 14 CENSORED DEATHS 11 TERMINAL 35 | | | | UNCENSORED DEATHS | | 297 515 553 583 585 588 599 618 627 633 | | 645 652 658 667 | | CENSORED DEATHS | | 13 465 465 465 466 466 466 466 466 466 | | 466 | | | ================================================================================== CI PIGMENT RED 23 STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 723 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 723 (A) | | | |--------------------------------------------------------------------------------| | | | |UNTREATD | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 92.0 78.0 70.0 | |CONTROL | | | | | |1.0% | 96.7 96.7 96.7 96.7 95.0 93.3 89.2 87.1 78.8 70.5 | | | | | | | |2.5% | 100.0 100.0 100.0 100.0 100.0 96.3 92.3 90.3 82.3 72.2 | | | | | | | |5.0% | 100.0 100.0 100.0 98.3 98.3 98.3 96.3 86.0 73.7 71.7 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | UNTREATD 1.0% 2.5% 5.0% | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 70.0% 70.5% 72.2% 71.7% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.966N P=1.000 P=0.972N P=1.000 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 630.7 530.5 615.4 587.1 | |NATURAL DEATHS (C) | (14.3) (53.5) (24.9) (25.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 657.0 627.7 655.0 636.6 | |(STANDARD ERROR) | (12.7) (19.5) (13.6) (17.6) | | | | ================================================================================== (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) CI PIGMENT RED 23 KAPLAN-MEIER SURVIVAL CURVES UNTREATD CONTROL = 1 1.0% = 2 2.5% = 3 5.0% = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 2 3 4 | 1 2 22 1 4 1 4 4 | 22 3 1 1 4 4 | 2 2 3 3 3 1 1 1 4 4 90 + 22 3 3 1 1 4 4 4 | 2 2 3 11 3 44 P | 2 2 1 331 1 E | 2 2 2 3 3 11 4 R 80 + 2 2 11 44 C | 22 2 3 3 3 1 1 E | 3 3 N | 2 2 2 4 4 T 70 + 2 2 11 | 2 2 3 3 S | 2 2 1 11 U | 2 22 44 1 1 R 60 + 2 2 3 4 34 131 V | 2 2 1 I | 22 V | 2 2 33 A 50 + 2 2 L | 2 2 | | 40 + 22 | | 2 | 30 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 23 obs hidden. CI PIGMENT RED 23 KAPLAN-MEIER SURVIVAL CURVES UNTREATD CONTROL = 1 1.0% = 2 2.5% = 3 5.0% = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 2 4 3 1 | 22 4 3 3 4 | 1 1 | 2 2 3 3 41 1 P 95 + 2 2 E | 2 2 3 3 4 1 1 R | 3 3 11 C | 2 2 E 90 + 3 3 N | 2 2 3 3 T | 2 4 4 11 | 4 1 1 3 S 85 + 22 U | 441 31 3 R | 244 2 33 V | 2 2 I 80 + 4 41 13 3 V | 2 2 33 A | 44 1 1 L | 121 233 75 + 22 | 4 4 11 | 1 132 | 4 4 70 + 1 1 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 11 obs hidden.