TDMS Study 05121-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus SCOPOLAMINE HYDROBROMIDE TRIHYDRATE DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 TIME: 21:44:21 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01 ES 85227 ROUTE: GAVAGE NTP C#: 03098C PATHOLOGIST: M. RYAN CAS: 6533-68-2 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus SCOPOLAMINE HYDROBROMIDE TRIHYDRATE DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 TIME: 21:44:21 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01 ES 85227 ROUTE: GAVAGE NTP C#: 03098C PATHOLOGIST: M. RYAN CAS: 6533-68-2 SCOPOLAMINE HYDROBROMIDE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = O MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 28 CENSORED DEATHS 12 TERMINAL 20 | | | | UNCENSORED DEATHS | | 430 443 471 492 508 523 581 600 639 642 | | 645 649 655 656 656 660 663 671 673 686 | | 686 698 702 702 706 713 720 720 | | CENSORED DEATHS | | 273 456 456 456 456 456 456 456 456 456 | | 456 566 | | | |--------------------------------------------------------------------------------| | DOSE = 1 MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 34 CENSORED DEATHS 12 TERMINAL 14 | | | | UNCENSORED DEATHS | | 404 446 492 504 504 533 533 540 560 583 | | 585 589 592 612 631 632 656 658 660 660 | | 666 669 671 678 678 678 688 688 702 702 | | 702 706 713 715 | | CENSORED DEATHS | | 281 456 456 456 456 456 456 456 456 456 | | 456 561 | | | |--------------------------------------------------------------------------------| | DOSE = 5 MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 27 CENSORED DEATHS 11 TERMINAL 22 | | | | UNCENSORED DEATHS | | 178 463 565 576 576 589 596 609 625 627 | | 631 631 643 646 646 649 656 660 666 673 | | 681 686 686 686 706 713 713 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 456 | | 631 | | | ================================================================================== SCOPOLAMINE HYDROBROMIDE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 25 MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 21 CENSORED DEATHS 11 TERMINAL 28 | | | | UNCENSORED DEATHS | | 144 351 404 504 516 540 565 575 584 589 | | 589 656 666 673 673 679 684 685 686 692 | | 713 | | CENSORED DEATHS | | 126 456 456 456 456 456 456 456 456 456 | | 456 | | | ================================================================================== SCOPOLAMINE HYDROBROMIDE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE 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) | | | |--------------------------------------------------------------------------------| | | | |O MG/KG | 100.0 100.0 100.0 100.0 100.0 94.6 88.4 84.2 65.2 42.1 | | | | | | | |1 MG/KG | 100.0 100.0 100.0 100.0 98.3 96.6 84.3 73.8 59.0 29.5 | | | | | | | |5 MG/KG | 100.0 98.3 98.3 98.3 98.3 96.3 96.3 86.3 63.9 45.3 | | | | | | | |25 MG/KG | 100.0 98.3 98.3 96.6 94.9 94.9 88.7 78.4 76.3 57.8 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 42.1% 29.5% 45.3% 57.8% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.057N P=0.219 P=0.995N P=0.274N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 628.2 618.5 621.3 579.4 | |NATURAL DEATHS (C) | (16.6) (14.2) (20.0) (30.4) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 625.2 609.9 632.3 619.7 | |(STANDARD ERROR) | (15.3) (14.7) (14.9) (18.8) | | | | ================================================================================== (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) SCOPOLAMINE HYDROBROMIDE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = O MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 16 CENSORED DEATHS 10 TERMINAL 34 | | | | UNCENSORED DEATHS | | 374 437 461 463 562 562 582 611 611 627 | | 658 660 663 671 685 693 | | CENSORED DEATHS | | 457 457 457 457 457 457 457 457 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 1 MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 25 CENSORED DEATHS 18 TERMINAL 17 | | | | UNCENSORED DEATHS | | 239 299 357 358 377 379 408 422 463 463 | | 467 517 519 541 544 562 562 572 581 603 | | 624 628 628 635 635 | | CENSORED DEATHS | | 178 204 204 204 204 204 204 204 204 204 | | 204 204 204 204 204 204 204 379 | | | |--------------------------------------------------------------------------------| | DOSE = 5 MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 22 CENSORED DEATHS 12 TERMINAL 26 | | | | UNCENSORED DEATHS | | 237 325 373 404 467 471 547 547 555 600 | | 622 622 631 632 645 653 680 697 700 707 | | 708 709 | | CENSORED DEATHS | | 457 457 457 457 457 457 457 457 457 457 | | 652 700 | | | ================================================================================== SCOPOLAMINE HYDROBROMIDE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 25 MG/KG | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 23 CENSORED DEATHS 15 TERMINAL 22 | | | | UNCENSORED DEATHS | | 41 58 190 291 332 332 346 372 391 392 | | 394 473 485 502 520 570 576 590 603 607 | | 629 647 663 | | CENSORED DEATHS | | 178 254 336 457 457 457 457 457 457 457 | | 457 457 457 498 499 | | | ================================================================================== SCOPOLAMINE HYDROBROMIDE TRIHYDRATE 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) | | | |--------------------------------------------------------------------------------| | | | |O MG/KG | 100.0 100.0 100.0 100.0 98.3 92.6 92.6 86.6 74.5 68.5 | | | | | | | |1 MG/KG | 100.0 100.0 97.7 90.7 81.3 74.1 64.5 52.6 40.6 40.6 | | | | | | | |5 MG/KG | 100.0 100.0 98.3 96.7 93.3 89.3 89.3 81.2 68.9 56.2 | | | | | | | |25 MG/KG | 96.7 96.7 95.0 88.0 81.0 76.5 71.7 62.1 52.6 52.6 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 68.5% 40.6% 56.2% 52.6% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.311 P=0.002 P=0.286 P=0.041 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 582.5 495.3 569.6 435.0 | |NATURAL DEATHS (C) | (24.7) (22.9) (29.0) (36.8) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 642.9 475.8 622.2 538.5 | |(STANDARD ERROR) | (14.9) (27.5) (16.9) (23.9) | | | | ================================================================================== (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) SCOPOLAMINE HYDROBROMIDE TRIHYDRATE KAPLAN-MEIER SURVIVAL CURVES O MG/KG = 1 1 MG/KG = 2 5 MG/KG = 3 25 MG/KG = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 3 2 1 | 4 3 4 2 1 1 31 2 3 | 4 1 12 3 3 | 1414 90 + 214 1 24 3 3 | 1 22 4 1 313 P | 2 2 44 13 3 1 E | 2 2 4 R 80 + 3311 C | 2 2 33 4 4 E | 2 2 311 44 N | 2 2 T 70 + 1 1 | 2 32 44 S | 3 11 U | 2 21144 R 60 + 22114 4 V | 1 1 4 4 I | 11 V | 223 3 A 50 + 33 L | 2 2 111 | 3 3 | 2 2 11 40 + | | | 222 30 + 22 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 31 obs hidden. SCOPOLAMINE HYDROBROMIDE TRIHYDRATE KAPLAN-MEIER SURVIVAL CURVES O MG/KG = 1 1 MG/KG = 2 5 MG/KG = 3 25 MG/KG = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 3 2 1 | 4 4 4 3 2 2 3 1 1 1 | 4 42 2 3 3 11 | 4 4 22 3 13 1 P 90 + 4 4 2 2 3 3 E | 4 2 24 1 1 1 R | 2 2 33 C | 44 2 2 2 3 3 1 1 E 80 + 4 4 3 31 1 N | 4 4 4 3 3 1 1 T | 2 4 2 4 11 | 2 2 4 3 3 1 1 S 70 + 2 2 44 33 11 U | 4 4 313 1 R | 2 2 4 4 V | 33 I 60 + 22 4 4 33 V | 22 4 4 A | 2 2 4 4 3 3 L | 2 2 4 4 50 + | | 22 | 40 + 2 2 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 17 obs hidden.