Dosing Study Cause of Death
Age/ Duration Day of MedDRA Cause of Death
Study Arm Patient ID Gender Dosage (Days) Death Preferred Term Verbatim Term
———————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
A: Drug X AB12345-BRA-1-id-42 36/M 5040 mg 37 NA NA NA
AB12345-BRA-1-id-93 34/F 6720 mg 37 657 ADVERSE EVENT ADVERSE EVENT
AB12345-BRA-11-id-345 37/F 7680 mg 37 NA NA NA
AB12345-BRA-11-id-397 38/M 7680 mg 37 NA NA NA
AB12345-BRA-13-id-177 24/M 4800 mg 37 NA NA NA
AB12345-BRA-15-id-36 38/F 7200 mg 37 812 DISEASE PROGRESSION PROGRESSIVE DISEASE
AB12345-BRA-2-id-296 44/F 4800 mg 37 NA NA NA
AB12345-CAN-11-id-139 31/M 6000 mg 37 563 ADVERSE EVENT ADVERSE EVENT
AB12345-CHN-1-id-123 27/F 5280 mg 37 750 DISEASE PROGRESSION PROGRESSIVE DISEASE
AB12345-CHN-1-id-133 25/F 5520 mg 37 NA NA NA
AB12345-CHN-1-id-235 39/M 5520 mg 37 968 ADVERSE EVENT ADVERSE EVENT
AB12345-CHN-1-id-275 27/M 7200 mg 38 NA NA NA
AB12345-CHN-1-id-277 41/M 8160 mg 37 NA NA NA
AB12345-CHN-1-id-315 32/M 6480 mg 37 NA NA NA
AB12345-CHN-1-id-316 25/F 8400 mg 37 NA NA NA
AB12345-CHN-1-id-329 48/M 5520 mg 37 NA NA NA
AB12345-CHN-1-id-47 25/F 5520 mg 37 NA NA NA
AB12345-CHN-1-id-53 48/M 6960 mg 37 NA NA NA
AB12345-CHN-1-id-69 32/F 6960 mg 37 NA NA NA
AB12345-CHN-1-id-71 33/M 7440 mg 37 NA NA NA
AB12345-CHN-11-id-116 30/M 8880 mg 37 NA NA NA
AB12345-CHN-11-id-124 41/M 7440 mg 37 NA NA NA
AB12345-CHN-11-id-132 30/F 6000 mg 37 NA NA NA
AB12345-CHN-11-id-153 41/M 7680 mg 37 NA NA NA
AB12345-CHN-11-id-167 28/F 4800 mg 37 NA NA NA
AB12345-CHN-11-id-256 23/M 6720 mg 37 NA NA NA
AB12345-CHN-11-id-354 42/F 5280 mg 37 NA NA NA
AB12345-CHN-11-id-356 28/F 8160 mg 37 NA NA NA
AB12345-CHN-11-id-392 39/M 5280 mg 37 NA NA NA
AB12345-CHN-12-id-266 32/F 5520 mg 37 NA NA NA
AB12345-CHN-12-id-396 25/F 8880 mg 37 NA NA NA
AB12345-CHN-14-id-1 27/F 5760 mg 37 NA NA NA
AB12345-CHN-14-id-161 33/F 6480 mg 37 NA NA NA
AB12345-CHN-14-id-168 39/M 6960 mg 37 NA NA NA
AB12345-CHN-15-id-399 33/F 7200 mg 37 NA NA NA
AB12345-CHN-17-id-182 37/M 7680 mg 37 902 LOST TO FOLLOW UP OTHER
AB12345-CHN-17-id-309 36/F 7200 mg 37 NA NA NA
AB12345-CHN-17-id-92 29/M 5520 mg 38 721 LOST TO FOLLOW UP OTHER
AB12345-CHN-18-id-170 31/M 7200 mg 37 NA NA NA
AB12345-CHN-2-id-22 29/M 8400 mg 38 409 MISSING OTHER
AB12345-CHN-2-id-223 29/F 5760 mg 37 468 DISEASE PROGRESSION PROGRESSIVE DISEASE
AB12345-CHN-2-id-272 41/F 4320 mg 37 773 DISEASE PROGRESSION PROGRESSIVE DISEASE
AB12345-CHN-2-id-274 40/F 5520 mg 37 890 SUICIDE OTHER
AB12345-CHN-2-id-284 36/F 7200 mg 38 NA NA NA
AB12345-CHN-2-id-286 30/F 8400 mg 37 NA NA NA
AB12345-CHN-2-id-367 40/M 7440 mg 37 NA NA NA
AB12345-CHN-2-id-395 28/M 5520 mg 37 NA NA NA
AB12345-CHN-3-id-271 24/F 4320 mg 37 NA NA NA
AB12345-CHN-3-id-281 41/M 4560 mg 37 NA NA NA
AB12345-CHN-4-id-335 33/F 6720 mg 37 NA NA NA
AB12345-CHN-4-id-73 24/F 7920 mg 37 NA NA NA
AB12345-CHN-5-id-108 28/F 7440 mg 37 935 MISSING OTHER
AB12345-CHN-5-id-273 34/F 6240 mg 37 NA NA NA
AB12345-CHN-5-id-348 37/M 5520 mg 37 NA NA NA
AB12345-CHN-6-id-30 29/M 5280 mg 37 578 Post-study reporting of death OTHER
AB12345-CHN-8-id-205 34/F 5760 mg 37 NA NA NA
AB12345-CHN-9-id-374 31/F 6960 mg 37 NA NA NA
AB12345-GBR-1-id-319 36/F 8160 mg 37 531 ADVERSE EVENT ADVERSE EVENT
AB12345-JPN-18-id-189 48/M 7920 mg 37 NA NA NA
AB12345-JPN-5-id-326 34/F 7680 mg 37 NA NA NA
AB12345-NGA-1-id-388 39/F 5760 mg 37 NA NA NA
AB12345-NGA-1-id-46 28/M 6480 mg 37 697 DISEASE PROGRESSION PROGRESSIVE DISEASE
AB12345-NGA-11-id-41 29/M 8160 mg 37 NA NA NA
AB12345-NGA-2-id-353 28/M 6960 mg 37 NA NA NA
AB12345-PAK-1-id-148 46/M 7440 mg 37 NA NA NA
AB12345-PAK-1-id-79 37/M 5040 mg 37 NA NA NA
AB12345-PAK-11-id-187 32/F 6240 mg 37 NA NA NA
AB12345-PAK-12-id-328 21/F 7680 mg 37 NA NA NA
AB12345-PAK-13-id-251 32/M 7680 mg 37 NA NA NA
AB12345-RUS-1-id-52 40/F 6960 mg 37 1069 DISEASE PROGRESSION PROGRESSIVE DISEASE
AB12345-RUS-13-id-70 39/F 6720 mg 37 NA NA NA
AB12345-RUS-6-id-77 26/F 5760 mg 37 495 ADVERSE EVENT ADVERSE EVENT
AB12345-USA-11-id-32 24/F 7200 mg 37 NA NA NA
AB12345-USA-11-id-339 39/F 5280 mg 37 878 UNKNOWN OTHER
AB12345-USA-3-id-282 38/M 4800 mg 37 NA NA NA
AB12345-USA-9-id-130 40/M 5520 mg 37 NA NA NA
B: Placebo AB12345-BRA-1-id-236 32/M 6480 mg 37 NA NA NA
AB12345-BRA-1-id-65 25/F 9120 mg 37 NA NA NA
AB12345-BRA-12-id-59 36/M 6480 mg 38 NA NA NA
AB12345-BRA-4-id-383 30/F 7680 mg 37 NA NA NA
AB12345-CAN-1-id-341 43/F 5520 mg 37 1013 SUICIDE OTHER
AB12345-CAN-4-id-331 34/F 6480 mg 37 NA NA NA
AB12345-CHN-1-id-107 41/M 6240 mg 37 NA NA NA
AB12345-CHN-1-id-156 32/F 6000 mg 37 542 SUICIDE OTHER
AB12345-CHN-1-id-186 27/M 5520 mg 37 NA NA NA
AB12345-CHN-1-id-197 31/F 6960 mg 37 NA NA NA
AB12345-CHN-1-id-212 30/F 5040 mg 37 NA NA NA
AB12345-CHN-1-id-33 31/F 6960 mg 37 NA NA NA
AB12345-CHN-1-id-346 21/M 7920 mg 37 834 ADVERSE EVENT ADVERSE EVENT
AB12345-CHN-1-id-400 26/F 6960 mg 37 NA NA NA
AB12345-CHN-1-id-86 31/F 8640 mg 37 NA NA NA
AB12345-CHN-1-id-97 39/F 4080 mg 37 NA NA NA
AB12345-CHN-11-id-174 41/M 4320 mg 37 NA NA NA
AB12345-CHN-11-id-220 26/F 4560 mg 37 NA NA NA
AB12345-CHN-11-id-24 46/F 6720 mg 37 NA NA NA
AB12345-CHN-11-id-247 30/M 4560 mg 38 NA NA NA
AB12345-CHN-11-id-278 47/F 6480 mg 37 NA NA NA
AB12345-CHN-11-id-289 40/F 4800 mg 37 NA NA NA
AB12345-CHN-11-id-291 50/M 5760 mg 37 NA NA NA
AB12345-CHN-11-id-317 38/F 6240 mg 37 658 DISEASE PROGRESSION PROGRESSIVE DISEASE
AB12345-CHN-11-id-318 42/F 7920 mg 37 910 DISEASE PROGRESSION PROGRESSIVE DISEASE
AB12345-CHN-11-id-358 32/F 4560 mg 37 NA NA NA
AB12345-CHN-11-id-362 39/F 6240 mg 37 NA NA NA
AB12345-CHN-11-id-364 48/F 4800 mg 37 NA NA NA
AB12345-CHN-11-id-54 26/M 5040 mg 37 NA NA NA
AB12345-CHN-11-id-90 37/F 5760 mg 37 NA NA NA
AB12345-CHN-12-id-294 35/F 8400 mg 37 NA NA NA
AB12345-CHN-12-id-322 37/M 7920 mg 37 NA NA NA
AB12345-CHN-13-id-102 37/M 5280 mg 37 NA NA NA
AB12345-CHN-13-id-19 30/F 7440 mg 37 NA NA NA
AB12345-CHN-13-id-239 58/F 6720 mg 37 NA NA NA
AB12345-CHN-13-id-304 29/F 5280 mg 37 NA NA NA
AB12345-CHN-14-id-305 28/F 5760 mg 37 406 Post-study reporting of death OTHER
AB12345-CHN-16-id-323 51/M 7680 mg 37 NA NA NA
AB12345-CHN-17-id-48 32/F 6000 mg 37 NA NA NA
AB12345-CHN-2-id-118 36/F 7440 mg 37 NA NA NA
AB12345-CHN-2-id-332 31/F 5760 mg 37 NA NA NA
AB12345-CHN-2-id-34 48/M 5280 mg 37 NA NA NA
AB12345-CHN-3-id-333 30/F 8160 mg 37 NA NA NA
AB12345-CHN-4-id-122 23/M 8160 mg 37 NA NA NA
AB12345-CHN-5-id-231 37/F 4800 mg 37 468 ADVERSE EVENT ADVERSE EVENT
AB12345-CHN-5-id-338 37/F 7920 mg 38 NA NA NA
AB12345-CHN-6-id-385 40/F 7440 mg 37 NA NA NA
AB12345-CHN-7-id-126 27/M 7920 mg 37 1066 ADVERSE EVENT ADVERSE EVENT
AB12345-CHN-7-id-202 44/F 9120 mg 37 NA NA NA
AB12345-CHN-7-id-267 40/M 5280 mg 37 NA NA NA
AB12345-CHN-9-id-11 28/F 5280 mg 37 398 UNKNOWN OTHER
AB12345-CHN-9-id-147 26/F 6240 mg 37 NA NA NA
AB12345-GBR-17-id-211 62/M 5760 mg 37 455 DISEASE PROGRESSION PROGRESSIVE DISEASE
AB12345-GBR-6-id-111 30/F 5520 mg 37 NA NA NA
AB12345-JPN-1-id-21 29/F 7440 mg 38 NA NA NA
AB12345-JPN-14-id-194 28/F 5040 mg 37 NA NA NA
AB12345-NGA-1-id-325 28/F 5760 mg 37 935 DISEASE PROGRESSION PROGRESSIVE DISEASE
AB12345-NGA-2-id-308 26/F 5520 mg 37 NA NA NA
AB12345-PAK-1-id-112 44/M 4080 mg 37 NA NA NA
AB12345-PAK-1-id-169 29/M 7680 mg 37 NA NA NA
AB12345-PAK-1-id-17 33/M 7680 mg 37 NA NA NA
AB12345-RUS-5-id-29 58/M 6960 mg 37 NA NA NA
AB12345-USA-1-id-138 36/M 8160 mg 37 NA NA NA
AB12345-USA-1-id-261 32/F 4080 mg 37 NA NA NA
AB12345-USA-1-id-269 35/F 8400 mg 37 NA NA NA
AB12345-USA-1-id-394 46/F 6960 mg 37 NA NA NA
AB12345-USA-11-id-157 50/M 6720 mg 37 NA NA NA
AB12345-USA-12-id-152 29/F 6240 mg 37 NA NA NA
AB12345-USA-12-id-226 30/M 5040 mg 37 NA NA NA
AB12345-USA-4-id-190 53/M 4560 mg 37 NA NA NA
C: Combination AB12345-BRA-1-id-141 35/F 6960 mg 37 NA NA NA
AB12345-BRA-1-id-265 25/M 6000 mg 37 872 SUICIDE OTHER
AB12345-BRA-11-id-321 33/F 9360 mg 37 NA NA NA
AB12345-BRA-11-id-9 40/M 7200 mg 38 1091 DISEASE PROGRESSION PROGRESSIVE DISEASE
AB12345-BRA-4-id-368 46/M 6720 mg 37 NA NA NA
AB12345-BRA-5-id-234 32/M 4800 mg 37 NA NA NA
AB12345-CAN-4-id-324 32/M 6240 mg 37 NA NA NA
AB12345-CHN-1-id-181 47/F 5520 mg 37 NA NA NA
AB12345-CHN-1-id-208 28/M 7680 mg 37 NA NA NA
AB12345-CHN-1-id-233 36/F 7680 mg 37 406 MISSING OTHER
AB12345-CHN-1-id-279 33/M 7920 mg 37 NA NA NA
AB12345-CHN-1-id-312 34/F 5280 mg 37 NA NA NA
AB12345-CHN-1-id-347 33/M 7440 mg 37 NA NA NA
AB12345-CHN-1-id-376 41/F 5760 mg 38 NA NA NA
AB12345-CHN-1-id-64 34/F 6960 mg 37 NA NA NA
AB12345-CHN-1-id-74 23/F 8400 mg 37 NA NA NA
AB12345-CHN-1-id-78 44/F 8160 mg 37 NA NA NA
AB12345-CHN-11-id-113 38/M 6960 mg 37 NA NA NA
AB12345-CHN-11-id-146 28/F 5040 mg 37 NA NA NA
AB12345-CHN-11-id-158 24/F 7200 mg 37 NA NA NA
AB12345-CHN-11-id-184 38/F 8400 mg 37 1029 DISEASE PROGRESSION PROGRESSIVE DISEASE
AB12345-CHN-11-id-192 35/F 8640 mg 37 807 DISEASE PROGRESSION PROGRESSIVE DISEASE
AB12345-CHN-11-id-2 37/F 8880 mg 37 NA NA NA
AB12345-CHN-11-id-298 31/M 6720 mg 37 NA NA NA
AB12345-CHN-11-id-63 30/M 6720 mg 38 NA NA NA
AB12345-CHN-14-id-143 36/F 6720 mg 37 NA NA NA
AB12345-CHN-14-id-375 32/F 8400 mg 37 NA NA NA
AB12345-CHN-14-id-56 25/M 7440 mg 37 NA NA NA
AB12345-CHN-15-id-262 35/M 7680 mg 37 NA NA NA
AB12345-CHN-15-id-297 31/M 8880 mg 37 NA NA NA
AB12345-CHN-16-id-352 28/M 6480 mg 37 NA NA NA
AB12345-CHN-16-id-381 45/M 5760 mg 37 NA NA NA
AB12345-CHN-17-id-31 35/F 5760 mg 37 NA NA NA
AB12345-CHN-17-id-84 40/F 4560 mg 37 NA NA NA
AB12345-CHN-18-id-106 30/F 5040 mg 37 NA NA NA
AB12345-CHN-2-id-292 32/F 6960 mg 37 NA NA NA
AB12345-CHN-2-id-342 32/M 6000 mg 38 NA NA NA
AB12345-CHN-2-id-98 48/M 8400 mg 37 NA NA NA
AB12345-CHN-3-id-155 35/F 6000 mg 37 NA NA NA
AB12345-CHN-3-id-259 27/M 7440 mg 37 NA NA NA
AB12345-CHN-4-id-115 38/M 5760 mg 37 NA NA NA
AB12345-CHN-5-id-221 40/F 6720 mg 37 NA NA NA
AB12345-CHN-5-id-83 44/M 6960 mg 37 NA NA NA
AB12345-CHN-7-id-290 33/M 6000 mg 37 NA NA NA
AB12345-GBR-11-id-390 69/M 6000 mg 37 NA NA NA
AB12345-JPN-1-id-7 54/F 8880 mg 37 NA NA NA
AB12345-JPN-11-id-135 37/F 5760 mg 37 NA NA NA
AB12345-JPN-11-id-373 45/M 7440 mg 37 NA NA NA
AB12345-JPN-12-id-219 37/F 5520 mg 37 NA NA NA
AB12345-JPN-17-id-393 26/M 7920 mg 38 652 ADVERSE EVENT ADVERSE EVENT
AB12345-JPN-5-id-252 31/F 4800 mg 37 NA NA NA
AB12345-NGA-1-id-198 32/F 7680 mg 37 NA NA NA
AB12345-NGA-1-id-357 41/M 5040 mg 37 NA NA NA
AB12345-NGA-1-id-43 37/M 6720 mg 37 NA NA NA
AB12345-NGA-1-id-96 28/M 5760 mg 37 NA NA NA
AB12345-NGA-11-id-173 24/F 6000 mg 37 NA NA NA
AB12345-NGA-11-id-334 20/M 5280 mg 37 NA NA NA
AB12345-NGA-11-id-35 32/M 7440 mg 37 923 ADVERSE EVENT ADVERSE EVENT
AB12345-NGA-4-id-215 40/F 8880 mg 37 647 ADVERSE EVENT ADVERSE EVENT
AB12345-PAK-1-id-125 49/F 7200 mg 37 NA NA NA
AB12345-PAK-1-id-95 28/F 6240 mg 37 1027 Post-study reporting of death OTHER
AB12345-PAK-2-id-188 23/F 7200 mg 37 NA NA NA
AB12345-PAK-2-id-191 38/F 5520 mg 37 NA NA NA
AB12345-PAK-5-id-20 40/M 6960 mg 37 NA NA NA
AB12345-RUS-3-id-378 30/F 7440 mg 37 NA NA NA
AB12345-RUS-4-id-6 44/F 4320 mg 37 NA NA NA
AB12345-RUS-7-id-243 27/F 8400 mg 37 NA NA NA
AB12345-USA-1-id-137 29/M 5040 mg 37 NA NA NA
AB12345-USA-1-id-242 30/F 5760 mg 37 NA NA NA
AB12345-USA-1-id-254 28/F 5520 mg 37 NA NA NA
AB12345-USA-1-id-295 30/F 5280 mg 38 NA NA NA
AB12345-USA-12-id-140 32/F 7680 mg 37 NA NA NA
AB12345-USA-19-id-58 47/M 5520 mg 37 NA NA NA
AB12345-USA-2-id-110 35/F 7920 mg 37 NA NA NA
AB12345-USA-8-id-206 34/F 6240 mg 37 NA NA NA FDA Table 8
All Individual Patient Deaths, Safety Population, Pooled Analyses
make_table_08()
Required variables:
-
adae:USUBJID,AGE,SEX,AESDTH,DTHADY, and the variables specified bydth_vars,arm_var, andsaffl_var. -
adex(if specified):USUBJID,PARAMCD,TRTSDT,TRTEDT,AVAL,AVALU, and the variable specified bysaffl_var.
| Argument | Description | Default |
|---|---|---|
adae |
(data.frame) Dataset (typically ADAE) required to build table. |
No default |
adex |
(data.frame) Dataset (typically ADEX) required to build table. |
No default |
arm_var |
(character) Arm variable used to split table into columns. |
"ARM" |
saffl_var |
(character) Flag variable used to indicate inclusion in safety population. |
"SAFFL" |
dth_var |
(vector of character) additional death variables from adae to include in the table. |
c("DTHCAUS", "DTHCAT") |
lbl_dth_vars |
(vector of character) labels corresponding to variables in dth_vars to print in the table. Labels should be ordered according to the order of variables in dth_vars. |
c("Cause of Death\nMedDRA\nPreferred Term", "Cause of Death\nVerbatim Term") |
na_level |
(character) String to represent missing values. |
"NA" |
annotations |
(named list of character) List of annotations to add to the table. Valid annotation types are title, subtitles, main_footer, and prov_footer. Each name-value pair should use the annotation type as name and the desired string as value. |
NULL |
Source code for this function is available here.