TDMS Study 05108-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Mason DATE: 09/13/94
EXP: 05108 PROMETHAZINE HYDROCHLORIDE TIME: 21:50:37
TEST: 01 CAGES FROM 0000 TO LAST CAGE PAGE: 1
TEST TYPE: CHRONIC ROUTE: GAVAGE NTP C#: C60673
CONT: NO1-ES-45069 CAS: 58-33-3
PATHOLOGIST: R. FLEISCHMAN K. MURTHY
--------------------------------------------------------------------------------
REASONS FOR REMOVAL:
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REMOVAL DATE RANGE:
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NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Mason DATE: 09/13/94
EXP: 05108 PROMETHAZINE HYDROCHLORIDE TIME: 21:50:37
TEST: 01 CAGES FROM 0000 TO LAST CAGE
TEST TYPE: CHRONIC ROUTE: GAVAGE NTP C#: C60673
CONT: NO1-ES-45069 CAS: 58-33-3
PATHOLOGIST: R. FLEISCHMAN K. MURTHY
PROMETHAZINE HYDROCHLORIDE
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 717 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = VEHICLE |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 27 CENSORED DEATHS 10 TERMINAL 23 |
| |
| UNCENSORED DEATHS |
| 170 512 561 570 582 584 595 602 610 612 |
| 632 641 660 671 671 673 684 686 686 686 |
| 686 687 691 697 697 703 716 |
| CENSORED DEATHS |
| 462 462 462 462 462 463 463 463 463 463 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 8.3 MG/KG |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 32 CENSORED DEATHS 10 TERMINAL 18 |
| |
| UNCENSORED DEATHS |
| 184 192 259 491 497 501 525 525 529 555 |
| 563 568 568 570 578 589 589 612 623 641 |
| 647 654 655 656 658 675 675 681 696 700 |
| 704 716 |
| CENSORED DEATHS |
| 462 462 462 462 463 463 463 463 463 463 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 16.6 MG/KG |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 39 CENSORED DEATHS 10 TERMINAL 11 |
| |
| UNCENSORED DEATHS |
| 184 401 479 520 522 532 536 550 555 570 |
| 571 575 582 597 598 599 616 616 625 626 |
| 639 642 647 656 665 665 666 666 673 673 |
| 691 694 697 700 700 701 702 704 715 |
| CENSORED DEATHS |
| 462 462 462 462 462 463 463 463 463 463 |
| |
==================================================================================
PROMETHAZINE HYDROCHLORIDE
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 717 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 33.3 MG/KG |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 41 CENSORED DEATHS 9 TERMINAL 10 |
| |
| UNCENSORED DEATHS |
| 49 53 138 288 289 365 458 541 555 562 |
| 565 568 576 583 584 592 592 602 604 608 |
| 612 617 620 624 624 624 625 632 639 656 |
| 657 658 658 666 667 667 675 680 693 708 |
| 715 |
| CENSORED DEATHS |
| 462 462 462 462 462 462 463 463 463 |
| |
==================================================================================
PROMETHAZINE HYDROCHLORIDE
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 717 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 717 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|VEHICLE | 100.0 98.3 98.3 98.3 98.3 98.3 96.3 84.3 74.3 46.2 |
| | |
| | |
|8.3 | 100.0 100.0 95.0 95.0 95.0 95.0 82.9 66.7 50.5 36.4 |
|MG/KG | |
| | |
|16.6 | 100.0 100.0 98.3 98.3 96.7 94.7 86.6 68.5 48.3 22.2 |
|MG/KG | |
| | |
|33.3 | 96.7 95.0 95.0 90.0 90.0 88.3 86.3 64.2 36.1 20.1 |
|MG/KG | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| VEHICLE 8.3 16.6 33.3 |
| MG/KG MG/KG MG/KG |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 46.2% 36.4% 22.2% 20.1% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P<0.001 P=0.153 P=0.009 P<0.001 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 628.3 571.1 609.0 558.3 |
|NATURAL DEATHS (C) | (20.4) (23.8) (16.1) (25.9) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 634.7 596.8 604.4 570.3 |
|(STANDARD ERROR) | (14.5) (17.0) (14.3) (20.1) |
| | |
==================================================================================
(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)
PROMETHAZINE HYDROCHLORIDE
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = VEHICLE |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 17 CENSORED DEATHS 11 TERMINAL 32 |
| |
| UNCENSORED DEATHS |
| 412 413 462 473 477 513 546 547 574 629 |
| 636 645 673 674 684 717 722 |
| CENSORED DEATHS |
| 23 450 450 450 450 450 450 450 451 451 |
| 451 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 8.3 MG/KG |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 16 CENSORED DEATHS 10 TERMINAL 34 |
| |
| UNCENSORED DEATHS |
| 479 566 591 597 597 597 616 624 632 632 |
| 639 657 676 692 704 717 |
| CENSORED DEATHS |
| 450 450 450 450 450 451 451 451 451 451 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 16.6 MG/KG |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 19 CENSORED DEATHS 10 TERMINAL 31 |
| |
| UNCENSORED DEATHS |
| 306 360 457 475 479 547 550 550 576 604 |
| 614 643 644 652 666 675 685 686 689 |
| CENSORED DEATHS |
| 450 450 450 450 451 451 451 451 451 451 |
| |
==================================================================================
PROMETHAZINE HYDROCHLORIDE
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 33.3 MG/KG |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 27 CENSORED DEATHS 9 TERMINAL 24 |
| |
| UNCENSORED DEATHS |
| 83 259 259 311 311 371 393 393 421 441 |
| 442 470 499 550 550 552 562 575 587 590 |
| 591 629 640 651 666 689 702 |
| CENSORED DEATHS |
| 29 30 450 450 450 450 451 451 451 |
| |
==================================================================================
PROMETHAZINE HYDROCHLORIDE
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 | 100.0 100.0 100.0 100.0 96.6 90.4 88.4 82.2 76.1 65.8 |
| | |
| | |
|8.3 | 100.0 100.0 100.0 100.0 100.0 98.0 98.0 88.0 76.0 68.0 |
|MG/KG | |
| | |
|16.6 | 100.0 100.0 100.0 96.7 96.7 90.6 90.6 80.6 72.5 62.4 |
|MG/KG | |
| | |
|33.3 | 98.3 98.3 94.8 91.4 84.5 79.0 77.0 60.8 54.7 48.6 |
|MG/KG | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| VEHICLE 8.3 16.6 33.3 |
| MG/KG MG/KG MG/KG |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 65.8% 68.0% 62.4% 48.6% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.009 P=0.808N P=0.880 P=0.047 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 576.3 626.0 571.5 488.4 |
|NATURAL DEATHS (C) | (25.4) (14.6) (25.8) (29.6) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 627.5 655.1 632.7 564.9 |
|(STANDARD ERROR) | (18.6) (13.8) (16.1) (24.3) |
| | |
==================================================================================
(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)
PROMETHAZINE HYDROCHLORIDE
KAPLAN-MEIER SURVIVAL CURVES
VEHICLE = 1
8.3 MG/KG = 2
16.6 MG/KG = 3
33.3 MG/KG = 4
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100 + 1 4 1 2
| 44 4 1 22 2 3 3 1 1
| 4 2 4 3 2 3 11
| 4 4 1 1
90 + 4 4 22 23
| 4 33434 1 11
| 22 334 1 1
| 2 2 3
P 80 + 222 1 1
E | 333 11 1
R | 3 3 11
C | 224 4
E 70 + 2 2 11
N | 2342 11
T | 223
| 442 2
S 60 + 443 22
U | 322 11
R | 44 33 11
V | 3 3
I 50 + 2 2 11
V | 44 3322 1 1
A | 44 4 332 2 1
L |
40 + 3 322
| 332 2
| 4 4
|
30 + 44 33
| 44
| 44 343
| 43
20 + 4
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 36 obs hidden.
PROMETHAZINE HYDROCHLORIDE
KAPLAN-MEIER SURVIVAL CURVES
VEHICLE = 1
8.3 MG/KG = 2
16.6 MG/KG = 3
33.3 MG/KG = 4
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
105.34 +
|
|
|1 4 4 3 3 1 2
97.24 + 3 1 1 2 2
| 4 4 1 1 2 2
P | 11 22
E | 4 4 1 1 3
R 89.14 + 4 4 1 1
C | 4 4 11 2 2
E | 4 4 1 13 2 2
N | 44 13 3 12
T 81.03 + 4 4 33 11
| 4 4 3 1212
S | 4 4 12 1
U | 3 3 2 2
R 72.93 + 3 3112 2
V | 4 4 33 2 2
I | 4 4 31 1 2
V | 44 11
A 64.83 + 4 4 33 1 1
L | 3 3
| 4 4
| 4 4
56.72 + 44
| 4 4
| 4 4
| 4 4
48.62 + 4 4
|
-+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 19 obs hidden.