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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 858566216 | 8585662 | 16 | F | 20120202 | 20160717 | 20120530 | 20160720 | EXP | US-GLAXOSMITHKLINE-A0964632A | GLAXOSMITHKLINE | 36.62 | YR | F | Y | 100.00000 | KG | 20160720 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 858566216 | 8585662 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 24 NG/KG/MIN CONTINUOUS, CONCENTRATION 45,000 NG/ML, VIAL STRENGTH OF 1.5 MG, PUMP RATE 77 ML/DAY | U | C538970 | 20444 | 2 | DF | POWDER FOR INFUSION | |||||
| 858566216 | 8585662 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N513 | 20444 | POWDER FOR INFUSION | ||||||||
| 858566216 | 8585662 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | R271A | 20444 | POWDER FOR INFUSION | ||||||||
| 858566216 | 8585662 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | R614 | 20444 | POWDER FOR INFUSION | ||||||||
| 858566216 | 8585662 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S276 | 20444 | POWDER FOR INFUSION | ||||||||
| 858566216 | 8585662 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S562 | 20444 | POWDER FOR INFUSION | ||||||||
| 858566216 | 8585662 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 24 NG/KG/MIN; CONCENTRATION 45,000 NG/ML; PUMP RATE 77 ML/DAY; VIAL STRENGTH 1.5 MG, CO | U | S925 | 20444 | POWDER FOR INFUSION | |||||||
| 858566216 | 8585662 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 24 NG/KG/MIN CONTINUOUS | U | Z606 | 20444 | 24 | DF | POWDER FOR INFUSION | |||||
| 858566216 | 8585662 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | T366 | 20444 | POWDER FOR INFUSION | ||||||||
| 858566216 | 8585662 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 24 DF, UNK | U | T274 | 20444 | 24 | DF | POWDER FOR INFUSION | ||||||
| 858566216 | 8585662 | 11 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 24 NG/KG/MIN CONTINUOUSLY | U | U202 | 20444 | 24 | DF | POWDER FOR INFUSION | ||||||
| 858566216 | 8585662 | 12 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 24 NG/KG/MIN (CONCENTRATION 45,000 NG/ML, PUMP RATE 77 ML/DAY, VIAL STRENGTH 1.5 MG), CO | U | V380 | 20444 | 24 | DF | POWDER FOR INFUSION | |||||
| 858566216 | 8585662 | 13 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 24 NG/KG/MIN CONTINUOUS (CONCENTRATION 45,000 NG/ML, PUMP RATE 77 ML/DAY, VIAL STRENGTH 1.5 MG) | U | W674 | 20444 | POWDER FOR INFUSION | |||||||
| 858566216 | 8585662 | 14 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 24NG/KG/MIN | U | Z606 | 20444 | 24 | DF | POWDER FOR INFUSION | ||||||
| 858566216 | 8585662 | 15 | SS | SILDENAFIL CITRATE. | SILDENAFIL CITRATE | 1 | Unknown | UNK,U | U | 0 | |||||||||
| 858566216 | 8585662 | 16 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 858566216 | 8585662 | 1 | Pulmonary arterial hypertension |
| 858566216 | 8585662 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 858566216 | 8585662 | OT |
| 858566216 | 8585662 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 858566216 | 8585662 | Abdominal distension | |
| 858566216 | 8585662 | Device related infection | |
| 858566216 | 8585662 | Diarrhoea | |
| 858566216 | 8585662 | Dyspnoea | |
| 858566216 | 8585662 | Ear infection | |
| 858566216 | 8585662 | Fatigue | |
| 858566216 | 8585662 | Fluid overload | |
| 858566216 | 8585662 | Fluid retention | |
| 858566216 | 8585662 | Hospitalisation | |
| 858566216 | 8585662 | Hypertension | |
| 858566216 | 8585662 | Infusion site erythema | |
| 858566216 | 8585662 | Intestinal obstruction | |
| 858566216 | 8585662 | Pain in jaw | |
| 858566216 | 8585662 | Pneumonia | |
| 858566216 | 8585662 | Rash | |
| 858566216 | 8585662 | Thrombosis | |
| 858566216 | 8585662 | Tooth extraction |
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 |
|---|---|---|---|---|---|---|
| 858566216 | 8585662 | 1 | 20120131 | 0 | ||
| 858566216 | 8585662 | 2 | 20120131 | 0 | ||
| 858566216 | 8585662 | 3 | 20120131 | 0 | ||
| 858566216 | 8585662 | 4 | 20120131 | 0 | ||
| 858566216 | 8585662 | 5 | 20120131 | 0 | ||
| 858566216 | 8585662 | 6 | 20120131 | 0 | ||
| 858566216 | 8585662 | 8 | 20120201 | 0 | ||
| 858566216 | 8585662 | 13 | 20120201 | 0 | ||
| 858566216 | 8585662 | 14 | 20120201 | 0 |