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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 82783154 | 8278315 | 4 | F | 20111129 | 20160729 | 20111207 | 20160803 | EXP | US-GLAXOSMITHKLINE-A0927761A | GLAXOSMITHKLINE | 35.78 | YR | F | Y | 96.20000 | KG | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 82783154 | 8278315 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | U | H888 | 20444 | 36 | DF | POWDER FOR INJECTION | ||||||
| 82783154 | 8278315 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | K844 | 20444 | POWDER FOR INJECTION | ||||||||
| 82783154 | 8278315 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK, CO | U | Z880 | 20444 | POWDER FOR INJECTION | ||||||||
| 82783154 | 8278315 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 62 NG/KG/MIN CO (CONCENTRATION 90,000 NG/ML, PUMP RATE 89 ML/DAY, VIAL STRENGTH 1.5 MG | U | Z880 | 0 | SOLUTION FOR INJECTION | ||||||||
| 82783154 | 8278315 | 5 | C | OPSUMIT | MACITENTAN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 82783154 | 8278315 | 1 | Pulmonary arterial hypertension |
| 82783154 | 8278315 | 4 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 82783154 | 8278315 | OT |
| 82783154 | 8278315 | LT |
| 82783154 | 8278315 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 82783154 | 8278315 | Asthenia | |
| 82783154 | 8278315 | Catheter management | |
| 82783154 | 8278315 | Central venous catheter removal | |
| 82783154 | 8278315 | Central venous catheterisation | |
| 82783154 | 8278315 | Complication associated with device | |
| 82783154 | 8278315 | Device infusion issue | |
| 82783154 | 8278315 | Dizziness | |
| 82783154 | 8278315 | Drug administration error | |
| 82783154 | 8278315 | Dyspnoea | |
| 82783154 | 8278315 | Haemoptysis | |
| 82783154 | 8278315 | Lethargy | |
| 82783154 | 8278315 | Malaise | |
| 82783154 | 8278315 | Nausea | |
| 82783154 | 8278315 | Pneumonia | |
| 82783154 | 8278315 | Therapy cessation | |
| 82783154 | 8278315 | Thrombosis in device |
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 |
|---|---|---|---|---|---|---|
| 82783154 | 8278315 | 1 | 20100512 | 0 | ||
| 82783154 | 8278315 | 2 | 20100512 | 0 | ||
| 82783154 | 8278315 | 3 | 20150706 | 0 |