TDMS Study 99022-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Southern Research Inst AZT TRANSPLACENTAL CARCINOGENESIS STUDY DATE: 10/08/03
EXPERIMENT: 99022 TEST: 02 TIME: 16:02:48
TEST TYPE: PERINATAL EXPOS CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-15328 ROUTE: IN-UTERO NTP C#: C99022
PATHOLOGIST: HEATH, JAMES E. CAS: 30516-87-1
------------------------------------------------------------------------------------------------------------------------------------
FINAL/MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: MERGE 001 001,011 0 MG/KG/DY
MERGE 002 002,012 50 MG/KG/DY
MERGE 003 003,013 100 MG/KG/DY
MERGE 004 004,014 200 MG/KG/DY
MERGE 005 005,015 300 MG/KG/DY
MERGE 006 006,016 0 MG/KG/DY
MERGE 007 007,017 50 MG/KG/DY
MERGE 008 008,018 100 MG/KG/DY
MERGE 009 009,019 200 MG/KG/DY
MERGE 010 010,020 300 MG/KG/DY
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Southern Research Inst AZT TRANSPLACENTAL CARCINOGENESIS STUDY DATE: 10/08/03
EXPERIMENT: 99022 TEST: 02 TIME: 16:02:48
TEST TYPE: PERINATAL EXPOS CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-15328 ROUTE: IN-UTERO NTP C#: C99022
PATHOLOGIST: HEATH, JAMES E. CAS: 30516-87-1
AZT TRANSPLACENTAL CARCINOGENESIS STUDY
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 668 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 0 MG/KG/DY |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 31 CENSORED DEATHS 0 TERMINAL 19 |
| |
| UNCENSORED DEATHS |
| 104 111 308 322 329 329 373 392 413 418 |
| 446 453 463 475 486 488 497 532 538 560 |
| 565 567 601 603 614 619 621 635 641 654 |
| 661 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 50 MG/KG/DY |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 29 CENSORED DEATHS 0 TERMINAL 21 |
| |
| UNCENSORED DEATHS |
| 45 147 157 168 229 236 254 300 322 322 |
| 329 363 385 418 432 444 467 475 479 495 |
| 523 562 567 580 588 592 595 624 640 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 100 MG/KG/DY |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 36 CENSORED DEATHS 1 TERMINAL 13 |
| |
| UNCENSORED DEATHS |
| 147 187 214 229 243 308 320 322 376 376 |
| 413 434 474 481 482 489 490 505 510 532 |
| 536 538 544 546 567 570 598 605 606 607 |
| 608 627 631 633 648 651 |
| CENSORED DEATHS |
| 315 |
| |
==================================================================================
AZT TRANSPLACENTAL CARCINOGENESIS STUDY
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 668 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 200 MG/KG/DY |
| ---------------------------- |
| |
| TOTAL 36 UNCENSORED DEATHS 28 CENSORED DEATHS 1 TERMINAL 7 |
| |
| UNCENSORED DEATHS |
| 157 167 298 301 320 329 329 341 382 434 |
| 483 501 531 539 549 563 580 589 599 607 |
| 608 612 624 625 631 631 647 662 |
| CENSORED DEATHS |
| 159 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 300 MG/KG/DY |
| ---------------------------- |
| |
| TOTAL 32 UNCENSORED DEATHS 22 CENSORED DEATHS 2 TERMINAL 8 |
| |
| UNCENSORED DEATHS |
| 192 229 329 329 329 376 404 473 488 495 |
| 538 539 563 569 593 627 634 635 638 640 |
| 655 661 |
| CENSORED DEATHS |
| 41 41 |
| |
==================================================================================
AZT TRANSPLACENTAL CARCINOGENESIS STUDY
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 668 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 668 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|0 | 100.0 96.0 96.0 88.0 80.0 72.0 62.0 52.0 38.0 38.0 |
|MG/KG/DY | |
| | |
|50 | 98.0 92.0 86.0 76.0 72.0 62.0 58.0 46.0 42.0 42.0 |
|MG/KG/DY | |
| | |
|100 | 100.0 98.0 90.0 83.9 77.8 69.6 53.2 43.0 26.6 26.6 |
|MG/KG/DY | |
| | |
|200 | 100.0 94.4 94.4 77.2 74.3 68.6 60.0 45.8 20.0 20.0 |
|MG/KG/DY | |
| | |
|300 | 100.0 100.0 93.3 83.3 76.7 73.3 60.0 50.0 26.7 26.7 |
|MG/KG/DY | |
| | |
==================================================================================
AZT TRANSPLACENTAL CARCINOGENESIS STUDY
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 668 DAYS
===============================================================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|-----------------------------------------------------------------------------------------------------------------------------|
| DOSE |
| |
| 0 50 100 200 300 |
| MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|-----------------------------------------------------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 38.0% 42.0% 26.6% 20.0% 26.7% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.249 P=1.000 P=0.288 P=0.161 P=0.553 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 478.0 404.8 473.5 487.1 497.1 |
|NATURAL DEATHS (C) | (26.1) (30.5) (24.1) (28.7) (31.0) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 550.2 515.3 520.9 513.2 511.3 |
|(STANDARD ERROR) | (20.8) (25.6) (21.5) (27.2) (33.1) |
| | |
===============================================================================================================================
(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)
AZT TRANSPLACENTAL CARCINOGENESIS STUDY
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 668 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 0 MG/KG/DY |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 30 CENSORED DEATHS 0 TERMINAL 20 |
| |
| UNCENSORED DEATHS |
| 105 179 248 255 287 352 372 391 443 443 |
| 460 497 510 535 558 573 577 581 588 588 |
| 593 598 598 599 609 612 644 648 651 658 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 50 MG/KG/DY |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 31 CENSORED DEATHS 1 TERMINAL 18 |
| |
| UNCENSORED DEATHS |
| 207 219 290 326 341 350 369 395 412 417 |
| 441 472 475 475 476 500 500 521 536 539 |
| 549 556 559 560 560 565 577 577 600 644 |
| 655 |
| CENSORED DEATHS |
| 402 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 100 MG/KG/DY |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 26 CENSORED DEATHS 0 TERMINAL 24 |
| |
| UNCENSORED DEATHS |
| 181 182 237 322 328 332 362 425 432 460 |
| 490 495 514 524 537 574 585 590 612 619 |
| 621 631 640 650 654 666 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
AZT TRANSPLACENTAL CARCINOGENESIS STUDY
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 668 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 200 MG/KG/DY |
| ---------------------------- |
| |
| TOTAL 40 UNCENSORED DEATHS 20 CENSORED DEATHS 0 TERMINAL 20 |
| |
| UNCENSORED DEATHS |
| 359 414 488 497 510 510 523 530 539 541 |
| 561 565 572 603 608 614 641 646 662 667 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 300 MG/KG/DY |
| ---------------------------- |
| |
| TOTAL 42 UNCENSORED DEATHS 23 CENSORED DEATHS 0 TERMINAL 19 |
| |
| UNCENSORED DEATHS |
| 43 49 207 325 332 412 453 455 467 474 |
| 479 482 482 530 539 565 580 585 593 593 |
| 598 641 645 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
AZT TRANSPLACENTAL CARCINOGENESIS STUDY
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 668 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 668 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|0 | 100.0 96.0 92.0 88.0 84.0 78.0 72.0 52.0 40.0 40.0 |
|MG/KG/DY | |
| | |
|50 | 100.0 100.0 96.0 88.0 79.9 69.7 59.4 41.0 36.9 36.9 |
|MG/KG/DY | |
| | |
|100 | 100.0 100.0 94.0 86.0 84.0 80.0 70.0 64.0 50.0 48.0 |
|MG/KG/DY | |
| | |
|200 | 100.0 100.0 100.0 97.5 95.0 95.0 75.0 65.0 52.5 50.0 |
|MG/KG/DY | |
| | |
|300 | 95.2 95.2 92.9 88.1 85.7 69.0 64.3 50.0 45.2 45.2 |
|MG/KG/DY | |
| | |
==================================================================================
AZT TRANSPLACENTAL CARCINOGENESIS STUDY
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 668 DAYS
===============================================================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|-----------------------------------------------------------------------------------------------------------------------------|
| DOSE |
| |
| 0 50 100 200 300 |
| MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|-----------------------------------------------------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 40.0% 36.9% 48.0% 50.0% 45.2% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.398N P=0.549 P=0.521N P=0.336N P=0.942N |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 491.7 473.0 487.0 552.5 457.8 |
|NATURAL DEATHS (C) | (27.8) (20.8) (29.4) (17.8) (35.0) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 562.2 541.8 573.9 610.3 552.9 |
|(STANDARD ERROR) | (20.7) (18.7) (19.9) (12.8) (25.0) |
| | |
===============================================================================================================================
(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)
AZT TRANSPLACENTAL CARCINOGENESIS STUDY
KAPLAN-MEIER SURVIVAL CURVES
0 MG/KG/DY = 1
50 MG/KG/DY = 2
100 MG/KG/DY = 3
200 MG/KG/DY = 4
300 MG/KG/DY = 5
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100 + 1 2 1 3 4 5
| 2 11 2 44 3 5 5
| 1 2 22 3 3 3 41 1
| 2 2 3 11
90 + 223 3
| 2 2 43 31 1
| 2 2 24 1 1 1
| 5 5 11
P 80 + 22 4 3 531 1
E | 2 4 2 4 53 3 11 5
R | 2 2 2 3 1 1 1
C | 2 2 131
E 70 + 2 2 335
N | 2 2 4114 5
T | 2 22314 3 11
| 2 2 3 31 1
S 60 + 2 233 411
U | 2 4 25
R | 3 3 1 2 11
V | 5 224 1 1
I 50 + 3 33 22 115
V | 3 43 55
A | 233 1211
L | 1 1 2
40 + 4 4 55 11
| 3 4 3 11
| 33
| 445 5
30 + 3 355
| 3 53
| 4 4
| 4 4
20 + 44
|
---+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+--
0 10 20 30 40 50 60 70 80 90 100
WEEK
NOTE: 59 obs hidden.
AZT TRANSPLACENTAL CARCINOGENESIS STUDY
KAPLAN-MEIER SURVIVAL CURVES
0 MG/KG/DY = 1
50 MG/KG/DY = 2
100 MG/KG/DY = 3
200 MG/KG/DY = 4
300 MG/KG/DY = 5
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100 + 1 5 1 3 2 4
| 1 1 2 2 4 4
| 5 1 5 2 3 11 2 32 4 4
| 5 1 1 32 2 44
90 + 1 3 3221 4 4
| 3 213 21 5
P | 3 21 12 2 33 15 4 4
E | 22 3 3 44
R 80 + 2 21515 3 44
C | 2 15 2 31 4 4
E | 55 1 133 1 4 4
N | 3 1 1
T 70 + 25 2 53 141
| 55 1 13 4
S | 2 2 5 5 113 3
U | 2 2 5 5 4 33
R 60 + 2 2 511 4 4
V | 22 511 3 34 4
I | 33 3 4
V | 511 3344
A 50 + 22 51 1 5 3 3
L | 2 2 1 1 5 3
| 1 1 5
| 2 2 11
40 + 2 2 1 1
| 2 2
|
|
30 +
|
---+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+--
0 10 20 30 40 50 60 70 80 90 100
WEEK
NOTE: 41 obs hidden.