TDMS Study 05025-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst DATE: 09/04/94 EXP: 05025 ETHYLENE GLYCOL TIME: 06:15:40 TEST: 01 CAGES FROM 0000 TO LAST CAGE PAGE: 1 TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 00920A CONT: N01CP9565102 CAS: 107-21-1 PATHOLOGIST: D. FARNELL 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: 09/04/94 EXP: 05025 ETHYLENE GLYCOL TIME: 06:15:40 TEST: 01 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 00920A CONT: N01CP9565102 CAS: 107-21-1 PATHOLOGIST: D. FARNELL S. EUSTIS ETHYLENE GLYCOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 731 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = UNTREATD CONTROL | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 25 CENSORED DEATHS 6 TERMINAL 29 | | | | UNCENSORED DEATHS | | 54 120 123 126 136 145 186 213 350 386 | | 415 469 538 585 595 598 602 602 630 637 | | 649 654 667 682 709 | | CENSORED DEATHS | | 465 465 465 465 465 465 | | | |--------------------------------------------------------------------------------| | DOSE = 0.625% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 22 CENSORED DEATHS 6 TERMINAL 32 | | | | UNCENSORED DEATHS | | 98 175 346 394 514 514 578 599 599 601 | | 601 624 627 641 654 654 667 682 693 697 | | 697 709 | | CENSORED DEATHS | | 463 463 463 463 463 463 | | | |--------------------------------------------------------------------------------| | DOSE = 1.25% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 22 CENSORED DEATHS 6 TERMINAL 32 | | | | UNCENSORED DEATHS | | 31 32 42 46 93 121 383 384 384 384 | | 513 517 584 598 607 620 622 633 654 667 | | 697 705 | | CENSORED DEATHS | | 463 463 463 463 463 463 | | | ================================================================================== ETHYLENE GLYCOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 731 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 2.5% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 31 CENSORED DEATHS 6 TERMINAL 23 | | | | UNCENSORED DEATHS | | 60 91 98 101 126 127 144 145 149 150 | | 154 161 168 215 241 317 386 498 519 590 | | 595 597 654 667 681 681 682 697 709 709 | | 722 | | CENSORED DEATHS | | 463 463 463 463 463 463 | | | ================================================================================== ETHYLENE GLYCOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 731 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 731 (A) | | | |--------------------------------------------------------------------------------| | | | |UNTREATD | 98.3 90.0 86.7 85.0 81.7 79.8 77.9 68.4 60.8 55.1 | |CONTROL | | | | | |0.625% | 100.0 96.7 96.7 95.0 93.3 93.3 89.6 80.3 70.9 59.7 | | | | | | | |1.25% | 93.3 90.0 90.0 90.0 83.3 83.3 79.5 75.8 66.3 60.6 | | | | | | | |2.5% | 98.3 78.3 75.0 73.3 71.7 71.7 67.8 62.0 60.0 44.5 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | UNTREATD 0.625% 1.25% 2.5% | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 55.1% 59.7% 60.6% 44.5% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.136 P=0.455N P=0.706N P=0.306 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 434.8 562.0 423.5 381.7 | |NATURAL DEATHS (C) | (45.4) (35.5) (53.0) (45.4) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 581.0 642.2 591.5 523.8 | |(STANDARD ERROR) | (26.6) (18.2) (27.3) (31.7) | | | | ================================================================================== (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) ETHYLENE GLYCOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 731 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = UNTREATD CONTROL | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 17 CENSORED DEATHS 10 TERMINAL 33 | | | | UNCENSORED DEATHS | | 472 518 520 536 546 574 578 581 605 606 | | 655 665 665 696 696 697 698 | | CENSORED DEATHS | | 465 465 465 465 465 465 465 465 465 465 | | | |--------------------------------------------------------------------------------| | DOSE = 1.25% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 20 CENSORED DEATHS 10 TERMINAL 30 | | | | UNCENSORED DEATHS | | 472 476 533 535 539 543 554 561 577 594 | | 612 633 644 663 679 688 696 696 718 725 | | CENSORED DEATHS | | 464 464 464 464 464 464 464 464 464 464 | | | |--------------------------------------------------------------------------------| | DOSE = 2.5% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 21 CENSORED DEATHS 9 TERMINAL 30 | | | | UNCENSORED DEATHS | | 98 367 490 500 511 535 538 548 579 612 | | 634 638 639 644 665 665 681 691 700 708 | | 730 | | CENSORED DEATHS | | 464 464 464 464 464 464 464 464 464 | | | ================================================================================== ETHYLENE GLYCOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 731 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 5.0% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 13 CENSORED DEATHS 10 TERMINAL 37 | | | | UNCENSORED DEATHS | | 391 457 469 500 541 634 639 659 665 665 | | 665 682 708 | | CENSORED DEATHS | | 464 464 464 464 464 464 464 464 464 464 | | | ================================================================================== ETHYLENE GLYCOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 731 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 731 (A) | | | |--------------------------------------------------------------------------------| | | | |UNTREATD | 100.0 100.0 100.0 100.0 100.0 98.0 92.0 82.0 74.0 66.0 | |CONTROL | | | | | |1.25% | 100.0 100.0 100.0 100.0 100.0 96.0 88.0 80.0 72.0 60.0 | | | | | | | |2.5% | 100.0 98.3 98.3 98.3 96.7 96.7 86.8 82.9 69.0 59.2 | | | | | | | |5.0% | 100.0 100.0 100.0 100.0 98.3 94.7 90.6 90.6 78.5 74.5 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | UNTREATD 1.25% 2.5% 5.0% | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 66.0% 60.0% 59.2% 74.5% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.371N P=0.649 P=0.554 P=0.514N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 606.4 606.9 579.7 590.4 | |NATURAL DEATHS (C) | (17.8) (17.8) (31.1) (29.0) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 651.4 645.1 638.0 656.0 | |(STANDARD ERROR) | (13.8) (14.0) (16.9) (14.7) | | | | ================================================================================== (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) ETHYLENE GLYCOL KAPLAN-MEIER SURVIVAL CURVES UNTREATD CONTROL = 1 0.625% = 2 1.25% = 3 2.5% = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 3 14 2 | 33 14 42 1 2 2 | 33 4 4 2 2 | 3 3 4 1411 2 2 P 90 + 34 1 1 3 2 2 E | 44 1 1 1 2 2 R | 1 1 C | 44 31 1 1 3 E 80 + 44 1 3 1 3 2 2 N | 4 4 4 1 1 3 2 2 T | 4 4 1 113 3 2 2 | 4 4 4 S 70 + 4 4 3 3 2 2 2 U | 4 41 11 3 3 22 R | 44 1 1 3 22 V | 4 11 232 I 60 + 1 1 1 32 2 V | 4 1 1 A | 1 1 L | 4 4 50 + 4 4 | 4 4 | 4 4 | 40 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 32 obs hidden. ETHYLENE GLYCOL 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 3 4 1 | 3 3 4 4 | 1 1 | 3 442 3 1 1 2 95 + 4 3 3 | 1 1 | 33 11 | 3 34 4 90 + 21 1 | 44 P | 2 2 11 E | 3 322 4 4 R 85 + 3 3 C | 2 1 1 E | 2 2 3 N | 3 3 T 80 + 2 12 1 | 33 4 4 S | 2 2 1 1 U | 22 4 4 R 75 + 4 4 V | 2 1 1 I | 3 2 2 V | A 70 + 2 2 L | 3 3 | 322 | 1 1 65 + 33 | 2 32 | 22 | 3 3 60 + 2 2 | 3 | | 55 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 14 obs hidden.