TDMS Study 05121-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus SCOPOLAMINE HYDROBROMIDE TRIHYDRATE DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 TIME: 22:23:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85227 ROUTE: GAVAGE NTP C#: 03098C PATHOLOGIST: A. SINGER 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: 07 TIME: 22:23:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85227 ROUTE: GAVAGE NTP C#: 03098C PATHOLOGIST: A. SINGER CAS: 6533-68-2 SCOPOLAMINE HYDROBROMIDE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 10 CENSORED DEATHS 20 TERMINAL 40 | | | | UNCENSORED DEATHS | | 294 447 540 647 680 683 694 700 707 725 | | CENSORED DEATHS | | 449 456 456 456 456 456 456 456 456 456 | | 456 456 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 0 MG/KG FEED RTD | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 8 CENSORED DEATHS 11 TERMINAL 41 | | | | UNCENSORED DEATHS | | 15 15 15 24 24 532 606 721 | | CENSORED DEATHS | | 7 456 456 456 456 456 456 456 456 456 | | 456 | | | |--------------------------------------------------------------------------------| | DOSE = 1 MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 11 CENSORED DEATHS 20 TERMINAL 39 | | | | UNCENSORED DEATHS | | 405 541 604 618 663 669 692 705 707 707 | | 709 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 456 | | 456 456 456 456 456 456 456 456 456 456 | | | ================================================================================== SCOPOLAMINE HYDROBROMIDE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 5 MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 9 CENSORED DEATHS 22 TERMINAL 39 | | | | UNCENSORED DEATHS | | 376 520 560 590 594 606 691 693 707 | | CENSORED DEATHS | | 50 131 456 456 456 456 456 456 456 456 | | 456 456 456 456 456 456 456 456 456 456 | | 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 25 MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 9 CENSORED DEATHS 22 TERMINAL 39 | | | | UNCENSORED DEATHS | | 405 405 432 587 594 622 697 705 707 | | CENSORED DEATHS | | 300 456 456 456 456 456 456 456 456 456 | | 456 456 456 456 456 456 456 456 456 456 | | 456 627 | | | ================================================================================== SCOPOLAMINE HYDROBROMIDE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE 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 MG/KG | 100.0 100.0 100.0 98.6 98.6 97.1 95.1 95.1 93.1 81.0 | | | | | | | |0 | 91.5 91.5 91.5 91.5 91.5 91.5 89.4 89.4 87.4 85.3 | |MG/KG FEED |TD | | | | |1 MG/KG | 100.0 100.0 100.0 100.0 98.6 98.6 96.6 94.5 90.5 78.5 | | | | | | | |5 MG/KG | 100.0 100.0 100.0 100.0 98.5 98.5 96.4 90.1 88.0 81.8 | | | | | | | |25 MG/KG | 100.0 100.0 100.0 100.0 97.1 95.7 95.7 91.5 89.4 83.0 | | | | | | | ================================================================================== SCOPOLAMINE HYDROBROMIDE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 726 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 0 1 MG/KG 5 MG/KG 25 MG/KG | | MG/KG FEED RTD | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 81.0% 85.3% 78.5% 81.8% 83.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=1.000N ----- P=0.992 P=1.000N P=1.000N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 611.7 244.0 638.2 593.0 572.7 | |NATURAL DEATHS (C) | (44.8) ( 111) (28.4) (34.6) (42.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 632.4 604.8 635.1 613.6 621.6 | |(STANDARD ERROR) | (15.5) (28.7) (14.8) (18.4) (15.9) | | | | =============================================================================================================================== (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 STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 16 CENSORED DEATHS 21 TERMINAL 33 | | | | UNCENSORED DEATHS | | 492 511 581 594 604 610 611 611 618 661 | | 679 707 709 712 717 720 | | CENSORED DEATHS | | 7 373 457 457 457 457 457 457 457 457 | | 457 457 457 457 457 457 457 457 457 457 | | 457 | | | |--------------------------------------------------------------------------------| | DOSE = 0 MG/KG FEED RTD | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 13 CENSORED DEATHS 11 TERMINAL 36 | | | | UNCENSORED DEATHS | | 464 589 611 617 618 630 686 707 707 709 | | 720 721 723 | | CENSORED DEATHS | | 7 457 457 457 457 457 457 457 457 457 | | 457 | | | |--------------------------------------------------------------------------------| | DOSE = 1 MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 14 CENSORED DEATHS 20 TERMINAL 36 | | | | UNCENSORED DEATHS | | 415 448 482 532 562 590 594 630 676 680 | | 694 705 708 708 | | CENSORED DEATHS | | 457 457 457 457 457 457 457 457 457 457 | | 457 457 457 457 457 457 457 457 457 457 | | | ================================================================================== SCOPOLAMINE HYDROBROMIDE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 5 MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 12 CENSORED DEATHS 21 TERMINAL 37 | | | | UNCENSORED DEATHS | | 243 302 356 510 578 604 617 647 676 678 | | 685 706 | | CENSORED DEATHS | | 373 457 457 457 457 457 457 457 457 457 | | 457 457 457 457 457 457 457 457 457 457 | | 457 | | | |--------------------------------------------------------------------------------| | DOSE = 25 MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 13 CENSORED DEATHS 19 TERMINAL 38 | | | | UNCENSORED DEATHS | | 350 399 432 468 544 551 604 636 670 677 | | 680 691 694 | | CENSORED DEATHS | | 457 457 457 457 457 457 457 457 457 457 | | 457 457 457 457 457 457 457 457 457 | | | ================================================================================== SCOPOLAMINE HYDROBROMIDE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE 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 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 95.9 89.8 79.6 67.3 | | | | | | | |0 | 100.0 100.0 100.0 100.0 100.0 98.0 98.0 95.9 87.8 73.5 | |MG/KG FEED |TD | | | | |1 MG/KG | 100.0 100.0 100.0 100.0 98.6 95.1 93.1 87.0 85.0 72.9 | | | | | | | |5 MG/KG | 100.0 100.0 98.6 95.7 95.7 95.7 93.6 89.5 85.3 77.0 | | | | | | | |25 MG/KG | 100.0 100.0 100.0 98.6 97.1 93.7 91.7 87.7 85.7 75.8 | | | | | | | ================================================================================== SCOPOLAMINE HYDROBROMIDE TRIHYDRATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 726 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 0 1 MG/KG 5 MG/KG 25 MG/KG | | MG/KG FEED RTD | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 67.3% 73.5% 72.9% 77.0% 75.8% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.854N ----- P=0.835N P=0.571N P=0.656N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 633.6 654.0 601.7 550.2 568.9 | |NATURAL DEATHS (C) | (17.9) (21.0) (27.1) (46.7) (33.7) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 616.5 653.6 624.3 614.0 623.8 | |(STANDARD ERROR) | (17.0) (17.3) (14.9) (16.7) (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) SCOPOLAMINE HYDROBROMIDE TRIHYDRATE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 0 MG/KG FEED RTD = 2 1 MG/KG = 3 5 MG/KG = 4 25 MG/KG = 5 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100.0 +1 2 1 4 3 | | 1 4 3 1 4 3 | 97.5 + | 5 5 1 1 | 4 3 4 3 | 5 5 95.0 + 22 1 1 | 4 4 3 3 P | 5 5 E | 1 1 R 92.5 + 3 3 C | E | 2 2 5 5 N | 33 T 90.0 + 4 4 | 2 2 5 5 S | 3 131 U | 4 4 R 87.5 + 2 55 2 V | I | 3 3 V | A 85.0 + 11 22 L | | 4 4 | 1 1 82.5 + | 4 4 | 1 | 33 80.0 + | | 3 3 | 77.5 + | -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 7 obs hidden. SCOPOLAMINE HYDROBROMIDE TRIHYDRATE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 0 MG/KG FEED RTD = 2 1 MG/KG = 3 5 MG/KG = 4 25 MG/KG = 5 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 5 3 2 1 | 4 4 5 5 3 3 | 4 4 5 5 3 2 3 1 1 2 | 4 5 5 1 1 2 2 95 + 3 3 | 5 4 5 1 1 22 P | 3 3 E | 55 3 4 1 1 R 90 + 5 1122 C | E | 3 5 425 4 2 N | 5 5 2 2 T 85 + 3 4 3 | 11 55 S | 33 U | 1 1 43 322 R 80 + 1 155 22 V | 4 33 I | 1 5513 4 V | 5 5 A 75 + 1122 L | 2 | 3 3 | 11 70 + | | 11 | 65 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 19 obs hidden.