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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1020658212 | 10206582 | 12 | F | 20141109 | 20160920 | 20140530 | 20160926 | EXP | US-GLAXOSMITHKLINE-A1045256A | GLAXOSMITHKLINE | 37.70 | YR | F | Y | 0.00000 | 20160926 | OT | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1020658212 | 10206582 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | CONCENTRATION 120,000 NG/ML, PUMP RATE 83 ML/DAY, VIAL STRENGTH 1.5 MG | U | P508 | 20444 | 115 | DF | POWDER FOR INFUSION | |||||
| 1020658212 | 10206582 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 118 NG/KG/MIN | U | T366 | 20444 | POWDER FOR INFUSION | ||||||||
| 1020658212 | 10206582 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 118NG/KG/MIN | U | T794 | 20444 | POWDER FOR INFUSION | ||||||||
| 1020658212 | 10206582 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK, CO | U | V049 | 20444 | POWDER FOR INFUSION | ||||||||
| 1020658212 | 10206582 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 118 NG/KG/MIN, CO | U | UNKNOWN | 20444 | POWDER FOR INFUSION | ||||||||
| 1020658212 | 10206582 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 118 NG/KG/MIN, CONTINUOUSLY | U | Z111 | 20444 | 118 | DF | POWDER FOR INFUSION | ||||||
| 1020658212 | 10206582 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 118 NG/KG/MIN, CONTINUOUSLY | U | Z880 | 20444 | 118 | DF | POWDER FOR INFUSION | ||||||
| 1020658212 | 10206582 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 116 NG/KG/MIN, CO | U | C769109 | 20444 | POWDER FOR INFUSION | ||||||||
| 1020658212 | 10206582 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 116 NG/KG/MIN, CO | U | J171 | 20444 | 116 | DF | POWDER FOR INFUSION | |||||
| 1020658212 | 10206582 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | C769109 | 0 | SOLUTION FOR INJECTION | |||||||||
| 1020658212 | 10206582 | 11 | C | TRACLEER | BOSENTAN | 1 | U | 0 | |||||||||||
| 1020658212 | 10206582 | 12 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 1020658212 | 10206582 | 13 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1020658212 | 10206582 | 1 | Pulmonary arterial hypertension |
| 1020658212 | 10206582 | 10 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1020658212 | 10206582 | HO |
| 1020658212 | 10206582 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1020658212 | 10206582 | Cough | |
| 1020658212 | 10206582 | Device alarm issue | |
| 1020658212 | 10206582 | Device infusion issue | |
| 1020658212 | 10206582 | Device leakage | |
| 1020658212 | 10206582 | Device related infection | |
| 1020658212 | 10206582 | Diarrhoea | |
| 1020658212 | 10206582 | Dyspnoea | |
| 1020658212 | 10206582 | Emergency care | |
| 1020658212 | 10206582 | Haematemesis | |
| 1020658212 | 10206582 | Haemoptysis | |
| 1020658212 | 10206582 | Hospitalisation | |
| 1020658212 | 10206582 | Ill-defined disorder | |
| 1020658212 | 10206582 | Malaise | |
| 1020658212 | 10206582 | Nausea | |
| 1020658212 | 10206582 | Pallor | |
| 1020658212 | 10206582 | Thrombosis | |
| 1020658212 | 10206582 | Vascular injury | |
| 1020658212 | 10206582 | Volume blood decreased | |
| 1020658212 | 10206582 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 1020658212 | 10206582 | 1 | 20090410 | 0 | ||
| 1020658212 | 10206582 | 5 | 20111021 | 0 | ||
| 1020658212 | 10206582 | 6 | 20111021 | 0 | ||
| 1020658212 | 10206582 | 7 | 20111021 | 0 | ||
| 1020658212 | 10206582 | 8 | 20111021 | 0 |