NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 11/15/04 EXPERIMENT: 96022 TEST: 02 TIME: 11:22:22 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX ------------------------------------------------------------------------------------------------------------------------------------ CORE + STOP STUDY FINAL #1; REVISION #1 RATS REASONS FOR REMOVAL: 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 11/15/04 EXPERIMENT: 96022 TEST: 02 TIME: 11:22:22 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 NG TEQ/KG | | ---------------------------- | | | | TOTAL 53 UNCENSORED DEATHS 26 CENSORED DEATHS 0 TERMINAL 27 | | | | UNCENSORED DEATHS | | 275 313 362 482 534 534 548 555 564 567 | | 582 586 623 628 628 639 639 649 651 665 | | 672 687 687 688 707 707 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 7 NG TEQ/KG | | ---------------------------- | | | | TOTAL 51 UNCENSORED DEATHS 34 CENSORED DEATHS 0 TERMINAL 17 | | | | UNCENSORED DEATHS | | 70 78 275 328 347 364 374 400 436 443 | | 484 485 498 525 525 534 534 541 567 594 | | 611 616 623 631 639 642 651 659 659 683 | | 691 700 705 714 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 22 NG TEQ/KG | | ---------------------------- | | | | TOTAL 53 UNCENSORED DEATHS 29 CENSORED DEATHS 0 TERMINAL 24 | | | | UNCENSORED DEATHS | | 63 399 408 426 443 443 455 471 474 504 | | 523 548 558 565 567 567 572 572 586 608 | | 611 632 639 651 659 659 700 703 707 | | CENSORED DEATHS | | NONE | | | ================================================================================== TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 72 NG TEQ/KG | | ---------------------------- | | | | TOTAL 53 UNCENSORED DEATHS 36 CENSORED DEATHS 2 TERMINAL 15 | | | | UNCENSORED DEATHS | | 78 261 367 480 534 537 539 541 548 552 | | 555 565 567 570 594 602 604 619 628 636 | | 651 653 656 659 659 662 663 667 678 686 | | 687 698 707 707 710 714 | | CENSORED DEATHS | | 41 390 | | | |--------------------------------------------------------------------------------| | DOSE = 216 NG TEQ/KG | | ---------------------------- | | | | TOTAL 53 UNCENSORED DEATHS 53 CENSORED DEATHS 0 TERMINAL 0 | | | | UNCENSORED DEATHS | | 166 267 313 337 349 373 383 397 446 447 | | 450 450 474 474 479 482 496 504 520 523 | | 525 527 530 530 534 536 548 555 555 565 | | 565 567 572 575 579 582 602 611 623 632 | | 639 639 639 639 649 667 672 674 674 674 | | 686 709 709 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 360 NG TEQ/KG | | ---------------------------- | | | | TOTAL 66 UNCENSORED DEATHS 66 CENSORED DEATHS 0 TERMINAL 0 | | | | UNCENSORED DEATHS | | 51 91 174 203 209 217 222 226 233 236 | | 237 243 243 245 254 260 267 267 267 267 | | 275 278 279 289 289 289 294 294 300 303 | | 313 313 321 329 329 336 337 338 342 349 | | 356 362 362 383 383 406 410 415 423 429 | | 446 452 453 456 461 478 482 482 491 504 | | 504 513 524 545 611 636 | | CENSORED DEATHS | | NONE | | | ================================================================================== TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 360 NG TEQKG ST | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 40 CENSORED DEATHS 0 TERMINAL 10 | | | | UNCENSORED DEATHS | | 201 209 226 226 226 230 232 240 241 247 | | 254 258 258 267 272 273 275 279 282 303 | | 383 401 451 474 494 504 525 541 561 593 | | 594 601 602 607 636 638 659 663 700 703 | | CENSORED DEATHS | | NONE | | | ================================================================================== TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 726 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 726 (A) | | | |--------------------------------------------------------------------------------| | | | |0 | 100.0 100.0 100.0 94.3 94.3 92.5 88.7 77.4 62.3 50.9 | |NG TEQ/K| | | | | |7 | 96.1 96.1 96.1 88.2 84.3 76.5 64.7 60.8 43.1 33.3 | |NG TEQ/K| | | | | |22 | 98.1 98.1 98.1 98.1 94.3 83.0 79.2 64.2 50.9 45.3 | |NG TEQ/KG| | | | | |72 | 98.1 98.1 96.2 96.2 94.2 92.3 84.4 66.7 47.1 29.4 | |NG TEQ/KG| | | | | |216 | 100.0 98.1 96.2 90.6 84.9 69.8 50.9 30.2 15.1 0.0 | |NG TEQ/KG | | | | | |360 | 98.5 95.5 69.7 34.8 25.8 12.1 3.0 3.0 0.0 0.0 | |NG TEQ/KG | | | | | |360 | 100.0 100.0 72.0 60.0 56.0 52.0 44.0 34.0 24.0 20.0 | |NG TEQKG S| | | | | ================================================================================== TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 726 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 7 22 72 216 360 360 | | NG TEQ/KG NG TEQ/KG NG TEQ/KG NG TEQ/KG NG TEQ/KG NG TEQ/KG NG TEQKG ST | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 50.9% 33.3% 45.3% 29.4% 0.0% 0.0% 20.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P=0.045 P=0.457 P=0.055 P<0.001 P<0.001 P<0.001 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 583.5 518.4 541.8 589.8 534.2 342.1 408.2 | |NATURAL DEATHS (C) | (22.6) (28.2) (24.1) (21.6) (16.1) (14.3) (27.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 656.1 587.6 625.2 614.2 534.2 342.1 471.8 | |(STANDARD ERROR) | (14.8) (23.3) (18.2) (20.6) (16.1) (14.3) (28.5) | | | | =============================================================================================================================== (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) TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) KAPLAN-MEIER SURVIVAL CURVES 0 NG TEQ/KG = 1 7 NG TEQ/KG = 2 22 NG TEQ/KG = 3 72 NG TEQ/KG = 4 216 NG TEQ/KG = 5 360 NG TEQ/KG = 6 360 NG TEQKG ST = 7 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 632 26 5 77 451 1 3 | 26 6 66 7 452 1 2 5 14 3 3 3 1 P | 66666 2 52 2 2 5 3 3 3 1 1 1 E | 6 6 2 5 52 25 3 3 3 44111 R 80 + 676 22 5 2 3 3 341 1 C | 666 5 552 2 2 3334 1 4 11 E | 66 5 55 2 2 33 444 1 11 N | 676 5 5 22 23 3 2 3 444 1 1 T 60 + 7667 7 7 55 2 32 3344 11 1 | 66 6 7 7 7 55 22 2234 3 1 1 S | 666 7 77 7 5 55 22 3 31 1 U | 666 7 7 55 2 2442 3 3 R 40 + 6666 555 77 222 V | 6 6 55 77 222 2 I | 6 666 5 5755 77 7 4 4 V | 666 6 6 5 55 7 7 A 20 + 66 77 7 L | 6 6 55 5 | 6 66 6 55 | 6 6 6 6 55 5 0 + 6 6 5 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 140 obs hidden.