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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123856078 | 12385607 | 8 | F | 20160815 | 20160818 | 20160519 | 20160825 | EXP | US-GLAXOSMITHKLINE-US2016GSK063311 | GLAXOSMITHKLINE | 65.41 | YR | F | Y | 0.00000 | 20160825 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123856078 | 12385607 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 12 NG/KG/MIN, CO | Z606 | 20444 | POWDER FOR INFUSION | ||||||||
| 123856078 | 12385607 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 14 NG/KG/MIN, CO | Z606 | 20444 | 14 | DF | POWDER FOR INFUSION | ||||||
| 123856078 | 12385607 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 8 NG/KG/MIN, CO | Z880 | 20444 | 8 | DF | POWDER FOR INFUSION | ||||||
| 123856078 | 12385607 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | C760234 | 0 | SOLUTION FOR INJECTION | |||||||||
| 123856078 | 12385607 | 5 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123856078 | 12385607 | 1 | Pulmonary hypertension |
| 123856078 | 12385607 | 2 | Pulmonary arterial hypertension |
| 123856078 | 12385607 | 4 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123856078 | 12385607 | OT |
| 123856078 | 12385607 | HO |
| 123856078 | 12385607 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123856078 | 12385607 | Accidental overdose | |
| 123856078 | 12385607 | Asthenia | |
| 123856078 | 12385607 | Death | |
| 123856078 | 12385607 | Diarrhoea | |
| 123856078 | 12385607 | Flushing | |
| 123856078 | 12385607 | Gastrointestinal disorder | |
| 123856078 | 12385607 | Injection site pruritus | |
| 123856078 | 12385607 | Nausea | |
| 123856078 | 12385607 | Oedema peripheral | |
| 123856078 | 12385607 | Pain | |
| 123856078 | 12385607 | Rehabilitation therapy | |
| 123856078 | 12385607 | Retching |
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 |
|---|---|---|---|---|---|---|
| 123856078 | 12385607 | 1 | 20160509 | 0 |