TDMS Study 05214-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Mason TRANS-DELTA-9-TETRAHYDROCANNABINOL DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 TIME: 12:27:42 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85212 ROUTE: GAVAGE NTP C#: 56371B PATHOLOGIST: K. MURTHY CAS: 1972-08-3 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Mason TRANS-DELTA-9-TETRAHYDROCANNABINOL DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 TIME: 12:27:42 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85212 ROUTE: GAVAGE NTP C#: 56371B PATHOLOGIST: K. MURTHY CAS: 1972-08-3 TRANS-DELTA-9-TETRAHYDROCANNABINOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 725 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | ---------------------------- | | | | TOTAL 80 UNCENSORED DEATHS 29 CENSORED DEATHS 29 TERMINAL 22 | | | | UNCENSORED DEATHS | | 438 499 500 505 508 516 524 540 556 566 | | 585 600 616 616 617 627 637 647 659 662 | | 671 678 683 683 709 715 717 718 721 | | CENSORED DEATHS | | 113 448 448 449 449 450 450 451 451 452 | | 452 456 456 456 456 456 456 456 456 456 | | 456 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 12.5 MG/KG | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 16 CENSORED DEATHS 9 TERMINAL 35 | | | | UNCENSORED DEATHS | | 282 368 456 527 600 610 627 637 643 662 | | 674 675 676 679 686 690 | | CENSORED DEATHS | | 448 448 449 449 450 450 450 451 452 | | | |--------------------------------------------------------------------------------| | DOSE = 25 MG/KG | | ---------------------------- | | | | TOTAL 70 UNCENSORED DEATHS 17 CENSORED DEATHS 20 TERMINAL 33 | | | | UNCENSORED DEATHS | | 211 289 324 325 378 450 592 640 650 651 | | 653 659 668 674 709 709 709 | | CENSORED DEATHS | | 88 448 448 449 449 450 450 451 451 452 | | 456 456 456 456 456 456 456 456 456 595 | | | ================================================================================== TRANS-DELTA-9-TETRAHYDROCANNABINOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 725 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 50 MG/KG | | ---------------------------- | | | | TOTAL 70 UNCENSORED DEATHS 20 CENSORED DEATHS 19 TERMINAL 31 | | | | UNCENSORED DEATHS | | 221 301 369 396 515 531 563 578 592 610 | | 611 659 662 668 684 687 688 690 697 710 | | CENSORED DEATHS | | 448 448 449 449 450 450 451 451 452 456 | | 456 456 456 456 456 456 456 456 589 | | | ================================================================================== TRANS-DELTA-9-TETRAHYDROCANNABINOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 725 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 725 (A) | | | |--------------------------------------------------------------------------------| | | | |0 | 100.0 100.0 100.0 100.0 100.0 98.7 84.9 77.0 61.2 43.4 | |MG/KG | | | | | |12.5 | 100.0 100.0 100.0 98.3 96.7 94.7 92.7 90.7 80.9 69.0 | |MG/KG | | | | | |25 | 100.0 100.0 98.6 94.2 92.8 91.2 91.2 89.2 78.8 68.4 | |MG/KG | | | | | |50 | 100.0 100.0 98.6 97.1 94.3 94.3 90.4 84.4 76.4 62.3 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 12.5 25 50 | | MG/KG MG/KG MG/KG MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 43.4% 69.0% 68.4% 62.3% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.254N P=0.020N P=0.047N P=0.131N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 610.8 593.3 546.5 571.6 | |NATURAL DEATHS (C) | (15.1) (30.7) (42.1) (32.0) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 581.1 648.6 600.7 609.3 | |(STANDARD ERROR) | (14.6) (15.4) (18.7) (16.2) | | | | ================================================================================== (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) TRANS-DELTA-9-TETRAHYDROCANNABINOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 725 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 26 CENSORED DEATHS 11 TERMINAL 23 | | | | UNCENSORED DEATHS | | 365 374 405 435 516 524 528 534 546 576 | | 590 590 620 626 626 632 632 633 637 638 | | 645 647 661 676 681 724 | | CENSORED DEATHS | | 435 454 454 455 455 456 456 457 457 458 | | 694 | | | |--------------------------------------------------------------------------------| | DOSE = 12.5 MG/KG | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 11 CENSORED DEATHS 9 TERMINAL 40 | | | | UNCENSORED DEATHS | | 276 534 558 565 584 590 619 650 659 681 | | 701 | | CENSORED DEATHS | | 454 454 455 455 456 456 457 457 458 | | | |--------------------------------------------------------------------------------| | DOSE = 25 MG/KG | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 15 CENSORED DEATHS 12 TERMINAL 33 | | | | UNCENSORED DEATHS | | 509 562 605 623 628 639 644 647 650 656 | | 661 694 696 715 721 | | CENSORED DEATHS | | 106 426 454 454 455 455 456 456 457 457 | | 458 639 | | | ================================================================================== TRANS-DELTA-9-TETRAHYDROCANNABINOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 725 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 50 MG/KG | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 15 CENSORED DEATHS 13 TERMINAL 32 | | | | UNCENSORED DEATHS | | 449 454 490 588 602 612 628 638 639 651 | | 651 656 659 659 717 | | CENSORED DEATHS | | 16 34 441 454 454 455 455 456 456 457 | | 457 458 458 | | | ================================================================================== TRANS-DELTA-9-TETRAHYDROCANNABINOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 725 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 725 (A) | | | |--------------------------------------------------------------------------------| | | | |0 | 100.0 100.0 100.0 98.3 95.0 93.3 85.2 77.1 54.8 48.6 | |MG/KG | | | | | |12.5 | 100.0 100.0 100.0 98.3 98.3 98.3 96.4 88.5 82.6 78.7 | |MG/KG | | | | | |25 | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 93.9 77.3 69.0 | |MG/KG | | | | | |50 | 100.0 100.0 100.0 100.0 100.0 96.5 94.3 90.1 70.8 68.6 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 12.5 25 50 | | MG/KG MG/KG MG/KG MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 48.6% 78.7% 69.0% 68.6% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.128N P=0.002N P=0.021N P=0.046N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 579.3 583.4 643.3 606.2 | |NATURAL DEATHS (C) | (18.8) (34.7) (14.4) (20.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 616.1 658.7 647.5 622.4 | |(STANDARD ERROR) | (15.1) (14.5) (16.1) (20.3) | | | | ================================================================================== (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) TRANS-DELTA-9-TETRAHYDROCANNABINOL KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 12.5 MG/KG = 2 25 MG/KG = 3 50 MG/KG = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 34 2 1 | 34 234 3 2 1 2 1 | 3 43 4 2 114 2 | 3 3 4 2 2 P 90 + 3 11 14 4 32 2 2 3 E | 1 1 4 4 4 2233 R | 1 1 4 4 22 C | 11 233 2 E 80 + 1 1 1 4 3 232 N | 1 1 433 T | 434 3 | 11 224 S 70 + 111 22 2 U | 1 1 44 3 3 R | 1 1 4 4 V | 4 4 I 60 + 111 V | 11 A | L | 1 11 50 + | | | 11 40 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 23 obs hidden. TRANS-DELTA-9-TETRAHYDROCANNABINOL KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 12.5 MG/KG = 2 25 MG/KG = 3 50 MG/KG = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 2 1 4 3 | 2 11 1 4 4 3 2 23 | 1 1 4 22 4 3 3 | 1 1 1 2 2 4 33 P 90 + 11 2 24 4 3 3 E | 11 2 424 2 R | 11 4 32 2 C | 1 1 433 2 2 E 80 + 1 1 3 3 2 2 N | 1 1 44 3 32 2 T | 11 4 4 | 3 3 S 70 + 11 4 33 U | 44 R | V | 11 I 60 + 11 V | 1 1 A | 1 1 L | 11 50 + 1 1 | 1 | | 40 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 14 obs hidden.