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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115429008 | 11542900 | 8 | F | 20160428 | 20160815 | 20150923 | 20160822 | PER | US-GLAXOSMITHKLINE-US2015GSK123090 | GLAXOSMITHKLINE | 53.79 | YR | F | Y | 0.00000 | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115429008 | 11542900 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 4 NG/KG/MIN CONTINUOUSLY | U | U660 | 20444 | 4 | DF | POWDER FOR INFUSION | |||||
| 115429008 | 11542900 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 6 NG/KG/MIN CONTINUOUSLY | U | U631 | 20444 | 6 | DF | POWDER FOR INFUSION | |||||
| 115429008 | 11542900 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 20 NG/KG/MIN (CONCENTRATION 15,000 NG/ML, PUMP RATE 86 ML/DAY, VIAL STRENGTH 1.5 MG), CO | U | V380 | 20444 | POWDER FOR INFUSION | ||||||||
| 115429008 | 11542900 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 15 NG/KG/MIN CONTINUOUSLY (CONCENTRATION 30,000 NG/ML, PUMP RATE 65 ML/DAY, 1.5 VIAL STRENGTH | U | V926 | 20444 | 15 | DF | POWDER FOR INFUSION | ||||||
| 115429008 | 11542900 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 27 NG/KG/MIN, CONCENTRATION 45,000, PUMP RATE: 78ML/DAY | U | V380 | 20444 | 27 | DF | POWDER FOR INFUSION | ||||||
| 115429008 | 11542900 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 44 NG/KG/MIN CONTINUOUS, CONCENTRATION: 75,000 NG/ML, PUMP RATE: 76 ML/DAY, VIAL STRENGTH: 1.5 MG/ML | U | Z111 | 20444 | POWDER FOR INFUSION | ||||||||
| 115429008 | 11542900 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 42 NG/KG/MIN, CONCENTRATION 75,000 NG/ML, PUMP RATE 78 ML/DAY | U | Z111 | 20444 | POWDER FOR INFUSION | ||||||||
| 115429008 | 11542900 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 47 NG/KG/MIN, CONCENTRATION 45,000 NG/ML, PUMP RATE 61 ML/DAY | U | Z606 | 20444 | POWDER FOR INFUSION | ||||||||
| 115429008 | 11542900 | 9 | SS | Flolan Diluent Solution for injection | GLYCINEMANNITOLSODIUM CHLORIDE | 1 | 47 NG/KG/MIN CONTINUOUSLY | U | Z606 | 0 | 47 | DF | SOLUTION FOR INJECTION | ||||||
| 115429008 | 11542900 | 10 | C | OPSUMIT | MACITENTAN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115429008 | 11542900 | 1 | Pulmonary arterial hypertension |
| 115429008 | 11542900 | 2 | Pulmonary hypertension |
| 115429008 | 11542900 | 9 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115429008 | 11542900 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115429008 | 11542900 | Catheter site erythema | |
| 115429008 | 11542900 | Catheter site pain | |
| 115429008 | 11542900 | Catheter site pruritus | |
| 115429008 | 11542900 | Cough | |
| 115429008 | 11542900 | Decreased appetite | |
| 115429008 | 11542900 | Device breakage | |
| 115429008 | 11542900 | Device leakage | |
| 115429008 | 11542900 | Diarrhoea | |
| 115429008 | 11542900 | Dizziness | |
| 115429008 | 11542900 | Drug dose omission | |
| 115429008 | 11542900 | Dyspnoea | |
| 115429008 | 11542900 | Dyspnoea exertional | |
| 115429008 | 11542900 | Fatigue | |
| 115429008 | 11542900 | Feeling abnormal | |
| 115429008 | 11542900 | Flushing | |
| 115429008 | 11542900 | Gout | |
| 115429008 | 11542900 | Medication error | |
| 115429008 | 11542900 | Nausea | |
| 115429008 | 11542900 | Pain in extremity | |
| 115429008 | 11542900 | Pain in jaw | |
| 115429008 | 11542900 | Product preparation error | |
| 115429008 | 11542900 | Product quality issue | |
| 115429008 | 11542900 | Pulmonary congestion | |
| 115429008 | 11542900 | Rash | |
| 115429008 | 11542900 | Respiration abnormal | |
| 115429008 | 11542900 | Skin exfoliation | |
| 115429008 | 11542900 | Tachycardia | |
| 115429008 | 11542900 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 115429008 | 11542900 | 1 | 20150821 | 0 | ||
| 115429008 | 11542900 | 4 | 20150821 | 0 | ||
| 115429008 | 11542900 | 5 | 20150821 | 0 | ||
| 115429008 | 11542900 | 6 | 20150821 | 0 | ||
| 115429008 | 11542900 | 7 | 20150821 | 0 | ||
| 115429008 | 11542900 | 8 | 20150821 | 0 | ||
| 115429008 | 11542900 | 9 | 20150821 | 0 |