TDMS Study 05090-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: American Biogenics Cor COUMARIN DATE: 10/22/97
EXPERIMENT: 05090 TEST: 01 TIME: 13:56:48
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01ES45039 ROUTE: GAVAGE NTP C#: 07103B
PATHOLOGIST: R. DAHLGREN CAS: 000091645
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 VEHICLE CONTROL
INCLUDE 002 VEHICLE CONTROL
INCLUDE 003 25 MG/KG
INCLUDE 004 25 MG/KG
INCLUDE 005 50 MG/KG
INCLUDE 006 50 MG/KG
INCLUDE 007 100MG/KG
INCLUDE 008 100MG/KG
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: American Biogenics Cor COUMARIN DATE: 10/22/97
EXPERIMENT: 05090 TEST: 01 TIME: 13:56:48
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01ES45039 ROUTE: GAVAGE NTP C#: 07103B
PATHOLOGIST: R. DAHLGREN CAS: 000091645
COUMARIN
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = VEHICLE CONTROL |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 20 CENSORED DEATHS 12 TERMINAL 28 |
| |
| UNCENSORED DEATHS |
| 372 408 420 472 513 573 578 586 601 609 |
| 611 622 623 660 671 694 699 704 720 728 |
| CENSORED DEATHS |
| 5 335 453 453 453 455 455 455 455 455 |
| 455 456 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 25 MG/KG |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 38 CENSORED DEATHS 13 TERMINAL 9 |
| |
| UNCENSORED DEATHS |
| 343 482 492 503 518 569 577 583 593 600 |
| 600 611 613 615 622 625 625 631 636 639 |
| 645 645 652 657 660 661 663 666 671 671 |
| 673 675 675 680 692 694 698 719 |
| CENSORED DEATHS |
| 90 352 377 453 453 453 453 455 455 455 |
| 455 456 456 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 50 MG/KG |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 47 CENSORED DEATHS 11 TERMINAL 2 |
| |
| UNCENSORED DEATHS |
| 408 429 473 496 498 506 506 512 517 525 |
| 531 531 533 539 545 546 548 555 556 569 |
| 575 580 580 588 594 596 596 601 602 607 |
| 615 615 622 622 622 625 628 630 631 643 |
| 643 645 657 666 678 679 694 |
| CENSORED DEATHS |
| 63 428 453 453 453 453 455 455 455 455 |
| 456 |
| |
==================================================================================
COUMARIN
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 100MG/KG |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 48 CENSORED DEATHS 12 TERMINAL 0 |
| |
| UNCENSORED DEATHS |
| 307 380 420 456 477 485 492 496 496 503 |
| 510 511 512 517 518 518 525 533 534 551 |
| 552 552 560 563 566 567 572 580 580 589 |
| 595 601 607 611 611 615 618 618 630 631 |
| 636 638 643 646 650 654 660 698 |
| CENSORED DEATHS |
| 19 426 453 453 453 453 455 455 455 455 |
| 456 456 |
| |
==================================================================================
COUMARIN
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 729 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|VEHICLE | 100.0 100.0 100.0 100.0 94.8 92.7 90.6 82.2 71.6 59.0 |
|CONTROL | |
| | |
|25 MG/KG | 100.0 100.0 100.0 98.3 98.3 96.2 89.8 76.9 42.7 19.2 |
| | |
| | |
|50 MG/KG | 100.0 100.0 100.0 100.0 98.3 94.5 69.9 41.1 12.3 4.1 |
| | |
| | |
|100MG/KG | 100.0 100.0 100.0 98.3 94.9 88.7 61.2 33.8 2.1 0.0 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| CONTROL |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 59.0% 19.2% 4.1% 0.0% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P<0.001 P<0.001 P<0.001 P<0.001 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 593.2 620.4 577.8 558.0 |
|NATURAL DEATHS (C) | (23.8) (11.9) ( 9.4) (11.0) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 619.4 591.6 553.2 529.6 |
|(STANDARD ERROR) | (19.1) (16.3) (13.3) (13.5) |
| | |
==================================================================================
(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)
COUMARIN
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = VEHICLE CONTROL |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 19 CENSORED DEATHS 12 TERMINAL 29 |
| |
| UNCENSORED DEATHS |
| 356 435 491 554 580 607 614 624 649 659 |
| 662 665 693 699 700 708 712 714 719 |
| CENSORED DEATHS |
| 92 184 455 455 455 455 455 456 456 456 |
| 456 456 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 25 MG/KG |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 11 CENSORED DEATHS 11 TERMINAL 38 |
| |
| UNCENSORED DEATHS |
| 334 334 439 531 547 654 659 659 662 693 |
| 713 |
| CENSORED DEATHS |
| 245 455 455 455 456 456 456 456 456 456 |
| 456 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 50 MG/KG |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 9 CENSORED DEATHS 15 TERMINAL 36 |
| |
| UNCENSORED DEATHS |
| 554 565 601 622 635 637 691 705 709 |
| CENSORED DEATHS |
| 13 21 34 67 189 455 455 455 455 456 |
| 456 456 456 456 456 |
| |
==================================================================================
COUMARIN
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 100MG/KG |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 20 CENSORED DEATHS 10 TERMINAL 30 |
| |
| UNCENSORED DEATHS |
| 375 463 491 543 551 580 619 629 641 642 |
| 651 651 658 665 679 679 686 693 699 699 |
| CENSORED DEATHS |
| 455 455 455 456 456 456 456 456 456 456 |
| |
==================================================================================
COUMARIN
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 729 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|VEHICLE | 100.0 100.0 100.0 98.3 98.3 96.6 94.5 90.3 75.6 60.9 |
|CONTROL | |
| | |
|25 MG/KG | 100.0 100.0 100.0 96.6 96.6 94.9 92.9 90.8 82.5 78.4 |
| | |
| | |
|50 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 93.3 86.7 80.0 |
| | |
| | |
|100MG/KG | 100.0 100.0 100.0 100.0 98.3 96.3 92.3 88.3 72.2 60.2 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| CONTROL |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 60.9% 78.4% 80.0% 60.2% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.616 P=0.133N P=0.070N P=0.990 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 623.2 565.9 635.4 614.7 |
|NATURAL DEATHS (C) | (23.3) (42.4) (19.1) (19.8) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 630.2 645.5 614.1 645.4 |
|(STANDARD ERROR) | (18.9) (17.2) (25.4) (14.4) |
| | |
==================================================================================
(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)
COUMARIN
KAPLAN-MEIER SURVIVAL CURVES
VEHICLE CONTROL = 1
25 MG/KG = 2
50 MG/KG = 3
100MG/KG = 4
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
100 + 1 4 2 1 3
| 4 2 1 4 11 3 32
| 1 4 12 22
| 4 14 32 1
90 + 44 331 1
| 44 33 111
| 21 1
| 44 3 3 2 211
80 + 44 33 2211
| 2 11
| 44 33 1 1
| 33 11
P 70 + 22 1 1
E | 4 4 33 22
R | 4 4 33 22 11
C | 3 3 1 1
E 60 + 4 4 33 22 11 1
N | 22
T | 44
| 44 33 3 22
S 50 + 33 2 2
U | 44
R | 44
V | 22
I 40 + 4 4333
V | 22
A | 44433
L | 44
30 + 33 22
| 22
| 44 22
| 33 2 2
20 + 4433 2 2
| 33
| 4433
| 3 3
10 + 44 33
| 44
| 4 4 3 3 3
| 4 4
0 + 4
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 28 obs hidden.
COUMARIN
KAPLAN-MEIER SURVIVAL CURVES
VEHICLE CONTROL = 1
25 MG/KG = 2
50 MG/KG = 3
100MG/KG = 4
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100 + 1 2 1 4 3
| 1 4 1 4
| 33
| 2 1 4 1
95 + 2 1 2 13 3
| 4 4 3 3
| 2 421 1
| 2 3 3 2
P 90 + 4 1 1
E | 4 114 2 2
R |
C | 1413 3
E 85 + 3 3
N | 1 41
T | 2 2 33
| 1 1
S 80 + 44 2 2 3
U | 2 2
R |
V | 44
I 75 + 1 1
V | 4 4 11
A | 4 4
L |
70 +
| 44 1 1
|
| 44
65 +
| 44
| 11
| 1 1
60 + 4 4
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 10 obs hidden.