Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85856138 | 8585613 | 8 | F | 20110603 | 20160705 | 20120530 | 20160711 | EXP | US-GLAXOSMITHKLINE-A0931181A | GLAXOSMITHKLINE | 48.35 | YR | M | Y | 71.80000 | KG | 20160711 | OT | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85856138 | 8585613 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Unknown | 40 UNK, CO | N145 | 20444 | 40 | DF | POWDER FOR INFUSION | ||||||
| 85856138 | 8585613 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 48 NG/KG/MIN | T366 | 20444 | POWDER FOR INFUSION | |||||||||
| 85856138 | 8585613 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 49 UNK, CO | U893 | 20444 | 49 | DF | POWDER FOR INFUSION | ||||||
| 85856138 | 8585613 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 51 DF, UNK | Z111 | 20444 | 51 | DF | POWDER FOR INFUSION | |||||||
| 85856138 | 8585613 | 5 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | 325 | MG | TABLET | ||||||||
| 85856138 | 8585613 | 6 | C | DIGOXIN. | DIGOXIN | 1 | U | 0 | 125 | UG | TABLET | ||||||||
| 85856138 | 8585613 | 7 | C | LETAIRIS | AMBRISENTAN | 1 | U | 0 | 10 | MG | TABLET | ||||||||
| 85856138 | 8585613 | 8 | C | SIMVASTATIN. | SIMVASTATIN | 1 | U | 0 | 40 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 85856138 | 8585613 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 85856138 | 8585613 | HO |
| 85856138 | 8585613 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 85856138 | 8585613 | Catheter site infection | |
| 85856138 | 8585613 | Cellulitis | |
| 85856138 | 8585613 | Central venous catheter removal | |
| 85856138 | 8585613 | Central venous catheterisation | |
| 85856138 | 8585613 | Device infusion issue | |
| 85856138 | 8585613 | Diplopia | |
| 85856138 | 8585613 | Dyspnoea | |
| 85856138 | 8585613 | Pallor | |
| 85856138 | 8585613 | Temporomandibular joint syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 85856138 | 8585613 | 1 | 20090127 | 0 | ||
| 85856138 | 8585613 | 3 | 2009 | 0 |