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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 910526619 | 9105266 | 19 | F | 20130123 | 20160919 | 20130220 | 20160922 | EXP | US-GLAXOSMITHKLINE-A1011461A | GLAXOSMITHKLINE | 47.46 | YR | F | Y | 0.00000 | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 910526619 | 9105266 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 23 NG/KG/MIN CONTINUOUSLYDOSE: 23.4 NG/KG/MIN, CONC: 30,000 NG/MLVIAL STRENGTH: 1.5 MG23.5 NG/K[...] | U | N307 | 20444 | 23 | DF | POWDER FOR INFUSION | |||||
| 910526619 | 9105266 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N145 | 20444 | POWDER FOR INFUSION | ||||||||
| 910526619 | 9105266 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | P057 | 20444 | POWDER FOR INFUSION | ||||||||
| 910526619 | 9105266 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | P669 | 20444 | POWDER FOR INFUSION | ||||||||
| 910526619 | 9105266 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S506 | 20444 | POWDER FOR INFUSION | ||||||||
| 910526619 | 9105266 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 23.5 NG/KG/MIN CONTINUOUS | U | T366 | 20444 | POWDER FOR INFUSION | ||||||||
| 910526619 | 9105266 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 24.7 NG/KG/MIN | U | T856 | 20444 | 24.7 | DF | POWDER FOR INFUSION | |||||
| 910526619 | 9105266 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 25 NG/KG/MIN | U | U052 | 20444 | POWDER FOR INFUSION | ||||||||
| 910526619 | 9105266 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | 20444 | POWDER FOR INFUSION | |||||||||
| 910526619 | 9105266 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | 20444 | POWDER FOR INFUSION | |||||||||
| 910526619 | 9105266 | 11 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 25 DF, CO | U | V785 | 20444 | 25 | DF | POWDER FOR INFUSION | |||||
| 910526619 | 9105266 | 12 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 26 NG/KG/MIN CONTINUOUS; CONCENTRATION 30,000 NG/ML; PUMP RATE 80 ML/DAY; VIAL STRENGTH 1.5 MG/ML | U | W674 | 20444 | POWDER FOR INFUSION | ||||||||
| 910526619 | 9105266 | 13 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 25.7 NG/KG/MIN CONTINUOUS; CONCENTRATION 30,000 NG/ML; PUMP RATE 79 ML/DAY; VIAL STRENGTH 1.5 MG/ML | U | Z880 | 20444 | POWDER FOR INFUSION | ||||||||
| 910526619 | 9105266 | 14 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 19.5 DF, CO | U | Z880 | 20444 | 19.5 | DF | POWDER FOR INFUSION | |||||
| 910526619 | 9105266 | 15 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 4.9 NG/KG/MIN, CO | U | V925 | 20444 | POWDER FOR INFUSION | ||||||||
| 910526619 | 9105266 | 16 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | CZ64454 | 0 | SOLUTION FOR INJECTION | ||||||||
| 910526619 | 9105266 | 17 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | C764454 | 0 | SOLUTION FOR INJECTION | ||||||||
| 910526619 | 9105266 | 18 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | C769109 | 0 | SOLUTION FOR INJECTION | ||||||||
| 910526619 | 9105266 | 19 | SS | UPTRAVI | SELEXIPAG | 1 | UNK | Y | 0 | ||||||||||
| 910526619 | 9105266 | 20 | SS | UPTRAVI | SELEXIPAG | 1 | 1400 UG, BID | Y | 0 | 1400 | UG | BID | |||||||
| 910526619 | 9105266 | 21 | SS | UPTRAVI | SELEXIPAG | 1 | 1200 UG, BID | Y | 0 | 1200 | UG | BID | |||||||
| 910526619 | 9105266 | 22 | C | TRACLEER | BOSENTAN | 1 | Oral | U | 0 | 125 | MG | BID | |||||||
| 910526619 | 9105266 | 23 | C | REVATIO | SILDENAFIL CITRATE | 1 | Oral | U | 0 | 20 | MG | TID | |||||||
| 910526619 | 9105266 | 24 | C | OPSUMIT | MACITENTAN | 1 | 0 | ||||||||||||
| 910526619 | 9105266 | 25 | C | ADCIRCA | TADALAFIL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 910526619 | 9105266 | 1 | Pulmonary arterial hypertension |
| 910526619 | 9105266 | 16 | Pulmonary arterial hypertension |
| 910526619 | 9105266 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 910526619 | 9105266 | OT |
| 910526619 | 9105266 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 910526619 | 9105266 | Catheter site erythema | |
| 910526619 | 9105266 | Catheter site infection | |
| 910526619 | 9105266 | Catheter site pain | |
| 910526619 | 9105266 | Catheter site swelling | |
| 910526619 | 9105266 | Chest pain | |
| 910526619 | 9105266 | Complication associated with device | |
| 910526619 | 9105266 | Device leakage | |
| 910526619 | 9105266 | Device related infection | |
| 910526619 | 9105266 | Diarrhoea | |
| 910526619 | 9105266 | Drug administration error | |
| 910526619 | 9105266 | Dyspnoea | |
| 910526619 | 9105266 | Feeling hot | |
| 910526619 | 9105266 | Flushing | |
| 910526619 | 9105266 | Food poisoning | |
| 910526619 | 9105266 | Headache | |
| 910526619 | 9105266 | Lower respiratory tract infection | |
| 910526619 | 9105266 | Nausea | |
| 910526619 | 9105266 | Pain | |
| 910526619 | 9105266 | Palpitations | |
| 910526619 | 9105266 | Pulmonary arterial hypertension | |
| 910526619 | 9105266 | Pulmonary hypertension | |
| 910526619 | 9105266 | Pyrexia | |
| 910526619 | 9105266 | Skin infection | |
| 910526619 | 9105266 | Upper respiratory tract infection |
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 |
|---|---|---|---|---|---|---|
| 910526619 | 9105266 | 1 | 20110923 | 0 | ||
| 910526619 | 9105266 | 2 | 20110924 | 0 | ||
| 910526619 | 9105266 | 3 | 20110924 | 0 | ||
| 910526619 | 9105266 | 4 | 20110924 | 0 | ||
| 910526619 | 9105266 | 5 | 20110924 | 0 | ||
| 910526619 | 9105266 | 11 | 20110923 | 0 | ||
| 910526619 | 9105266 | 12 | 20110923 | 0 | ||
| 910526619 | 9105266 | 13 | 20110923 | 0 | ||
| 910526619 | 9105266 | 15 | 20110923 | 0 | ||
| 910526619 | 9105266 | 19 | 20160724 | 0 |