TDMS Study 88035-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Battelle Columbus PRIMACLONE DATE: 12/27/96
EXPERIMENT: 88035 TEST: 05 TIME: 13:25:44
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-05295 ROUTE: DOSED FEED NTP C#: C88035
PATHOLOGIST: TOFT, J. CAS: 0000125-33-7
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: MERGE 001 001 0 PPM
MERGE 002 002 0 PPM
MERGE 003 003 600 PPM
MERGE 004 004 600 PPM
MERGE 005 005 1300 PPM
MERGE 006 006 1300 PPM
MERGE 007 007 2500 PPM
MERGE 008 008 2500 PPM
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Battelle Columbus PRIMACLONE DATE: 12/27/96
EXPERIMENT: 88035 TEST: 05 TIME: 13:25:44
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05295 ROUTE: DOSED FEED NTP C#: C88035
PATHOLOGIST: TOFT, J. CAS: 0000125-33-7
PRIMACLONE
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 723 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 0 PPM |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 37 CENSORED DEATHS 0 TERMINAL 13 |
| |
| UNCENSORED DEATHS |
| 281 305 457 463 505 509 526 560 568 574 |
| 575 583 585 591 619 627 641 645 646 652 |
| 655 655 662 667 669 669 674 676 683 692 |
| 697 698 704 710 710 715 719 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 600 PPM |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 43 CENSORED DEATHS 0 TERMINAL 7 |
| |
| UNCENSORED DEATHS |
| 330 502 502 503 526 542 544 562 579 583 |
| 609 610 619 619 627 634 635 635 641 641 |
| 642 652 654 661 669 669 669 670 673 674 |
| 674 683 683 694 697 697 703 709 709 710 |
| 712 712 715 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 1300 PPM |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 46 CENSORED DEATHS 0 TERMINAL 4 |
| |
| UNCENSORED DEATHS |
| 354 437 529 551 558 561 562 572 576 583 |
| 585 589 589 599 612 613 613 619 627 627 |
| 631 632 635 635 641 641 643 648 654 655 |
| 659 664 667 667 668 669 673 674 683 683 |
| 683 688 691 697 698 712 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
PRIMACLONE
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 723 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 2500 PPM |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 50 CENSORED DEATHS 0 TERMINAL 0 |
| |
| UNCENSORED DEATHS |
| 254 380 436 437 437 505 517 522 529 532 |
| 533 537 538 542 544 548 556 559 560 561 |
| 561 562 569 572 573 581 583 583 585 585 |
| 585 588 589 589 589 589 589 589 589 596 |
| 599 599 603 610 619 619 626 632 641 674 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
PRIMACLONE
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 723 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 723 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|0 PPM | 100.0 100.0 100.0 96.0 96.0 92.0 86.0 72.0 54.0 26.0 |
| | |
| | |
|600 PPM | 100.0 100.0 100.0 98.0 98.0 98.0 86.0 80.0 52.0 14.0 |
| | |
| | |
|1300 PPM | 100.0 100.0 100.0 98.0 98.0 96.0 94.0 72.0 36.0 8.0 |
| | |
| | |
|2500 PPM | 100.0 100.0 98.0 98.0 96.0 90.0 70.0 14.0 2.0 0.0 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| 0 PPM 600 PPM 1300 PPM 2500 PPM |
| |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 26.0% 14.0% 8.0% 0.0% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P<0.001 P=0.324 P=0.016 P<0.001 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 609.9 632.0 622.8 557.9 |
|NATURAL DEATHS (C) | (17.2) (11.8) ( 9.9) ( 9.8) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 639.3 644.7 630.8 557.9 |
|(STANDARD ERROR) | (14.5) (11.1) ( 9.9) ( 9.8) |
| | |
==================================================================================
(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)
PRIMACLONE
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 722 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 0 PPM |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 26 CENSORED DEATHS 0 TERMINAL 24 |
| |
| UNCENSORED DEATHS |
| 367 415 536 541 561 566 626 626 634 638 |
| 640 641 641 646 660 664 668 668 675 682 |
| 697 702 702 702 702 703 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 600 PPM |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 23 CENSORED DEATHS 0 TERMINAL 27 |
| |
| UNCENSORED DEATHS |
| 367 410 415 419 426 456 466 511 567 578 |
| 578 584 605 612 618 618 645 675 675 675 |
| 682 702 702 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 1300 PPM |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 0 TERMINAL 31 |
| |
| UNCENSORED DEATHS |
| 389 456 501 543 550 603 610 618 634 644 |
| 668 682 690 693 695 696 703 707 709 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
PRIMACLONE
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 722 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 2500 PPM |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 22 CENSORED DEATHS 0 TERMINAL 28 |
| |
| UNCENSORED DEATHS |
| 433 477 489 491 543 548 550 561 590 596 |
| 605 605 626 674 674 675 682 702 702 708 |
| 708 718 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
PRIMACLONE
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 722 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 722 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|0 PPM | 100.0 100.0 100.0 100.0 96.0 96.0 92.0 88.0 68.0 48.0 |
| | |
| | |
|600 PPM | 100.0 100.0 100.0 100.0 92.0 86.0 84.0 74.0 66.0 54.0 |
| | |
| | |
|1300 PPM | 100.0 100.0 100.0 100.0 98.0 96.0 92.0 88.0 80.0 62.0 |
| | |
| | |
|2500 PPM | 100.0 100.0 100.0 100.0 100.0 96.0 90.0 76.0 74.0 56.0 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| 0 PPM 600 PPM 1300 PPM 2500 PPM |
| |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 48.0% 54.0% 62.0% 56.0% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.450N P=0.968N P=0.219N P=0.597N |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 627.0 564.6 620.6 607.1 |
|NATURAL DEATHS (C) | (16.7) (22.4) (21.4) (18.5) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 672.6 649.6 683.5 671.5 |
|(STANDARD ERROR) | (11.0) (15.2) (10.6) (11.4) |
| | |
==================================================================================
(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)
PRIMACLONE
KAPLAN-MEIER SURVIVAL CURVES
0 PPM = 1
600 PPM = 2
1300 PPM = 3
2500 PPM = 4
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
112 +
|
|
| 1 4 1 1 2 3 4 3 2
96 + 1 4 3 11 3 3
| 4 1 21 2 2333
P | 14 41 2 123
E | 44 12122
R 80 + 44 111 3 22
C | 44 1 13 22
E | 44 13 3112
N | 44 331 11
T 64 + 44 332211
| 332 2
S | 44 1 11
U | 44 33 22
R 48 + 44 33 11
V | 33 2111
I | 3 3 2211
V | 4 4 33 2 111
A 32 + 11
L | 33 22211
| 44 33
| 33
16 + 444 33 222
| 44 3 3
| 444 3 3
| 44 4
0 + 4
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 44 obs hidden.
PRIMACLONE
KAPLAN-MEIER SURVIVAL CURVES
0 PPM = 1
600 PPM = 2
1300 PPM = 3
2500 PPM = 4
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100 + 1 1 3 4
| 1 3 21 4 3 4
| 21 3 4443 11
| 22 4 13 1
P 90 + 2 2 43 3
E | 22 1 33 1
R | 2 2 4 2 4 3311
C | 2 2 44 11
E 80 + 44 3 3
N | 22 3 3
T | 2 22 4 11 433
| 22 1 1 33
S 70 +
U | 2 2 1144 33
R | 2 114 33
V | 11 43 3
I 60 + 21 1
V | 2 1144
A | 2 42
L |
50 +
| 1 1
|
|
40 +
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 29 obs hidden.