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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 931953212 | 9319532 | 12 | F | 201512 | 20160912 | 20130530 | 20160915 | EXP | US-GLAXOSMITHKLINE-A0998844A | GLAXOSMITHKLINE | 49.15 | YR | F | Y | 0.00000 | 20160915 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 931953212 | 9319532 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 31 NG/KG/MIN CONTINUOUSLY, CONCENTRATION 60,000 NG/ML, VIAL STRENGTH 1.5 MG | U | M240 | 20444 | 31 | DF | POWDER FOR INFUSION | |||||
| 931953212 | 9319532 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N388 | 20444 | POWDER FOR INFUSION | ||||||||
| 931953212 | 9319532 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | P669 | 20444 | POWDER FOR INFUSION | ||||||||
| 931953212 | 9319532 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 40 NG/KG/MIN CO; CONCENTRATION: 60,000 NG/ML; PUMP RATE: 80 ML/DAY; VIAL STRENGTH: 1.5 MG | U | V785 | 20444 | POWDER FOR INFUSION | ||||||||
| 931953212 | 9319532 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 31 DF, CO | U | V785 | 20444 | 31 | DF | POWDER FOR INFUSION | ||||||
| 931953212 | 9319532 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 22 NG/KG/MIN, CONCENTRATION 45,000 NG/ML | U | V785 | 20444 | 22 | DF | POWDER FOR INFUSION | |||||
| 931953212 | 9319532 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 31 NG/KG/MIN, UNK | U | V785 | 20444 | 31 | DF | POWDER FOR INFUSION | ||||||
| 931953212 | 9319532 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 28 NG/KG/MIN, UNK | U | V934 | 20444 | 28 | DF | POWDER FOR INFUSION | |||||
| 931953212 | 9319532 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 22 NG/KG/MIN CONTINUOUS; CONCENTRATION: 45,000 NG/ML; PUMP RATE: 64 ML/DAY; VIAL STRENGTH: 1.5 MG | U | V394 | 20444 | POWDER FOR INFUSION | ||||||||
| 931953212 | 9319532 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 28 NG/KG/MIN CONTINUOUS; CONCENTRATION: 60,000 NG/ML; PUMP RATE: 73 ML/DAY; VIAL STRENGTH: 1.5 MG | U | W674 | 20444 | POWDER FOR INFUSION | |||||||
| 931953212 | 9319532 | 11 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 36 NG/KG/MIN CONTINUOUS | U | Z880 | 20444 | 36 | DF | POWDER FOR INFUSION | |||||
| 931953212 | 9319532 | 12 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | C769109 | 0 | SOLUTION FOR INJECTION | ||||||||
| 931953212 | 9319532 | 13 | C | COUMADIN | WARFARIN SODIUM | 1 | UNK | U | 0 | ||||||||||
| 931953212 | 9319532 | 14 | C | WARFARIN | WARFARIN | 1 | UNK | U | 0 | ||||||||||
| 931953212 | 9319532 | 15 | C | ADCIRCA | TADALAFIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 931953212 | 9319532 | 1 | Pulmonary arterial hypertension |
| 931953212 | 9319532 | 12 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 931953212 | 9319532 | OT |
| 931953212 | 9319532 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 931953212 | 9319532 | Adverse drug reaction | |
| 931953212 | 9319532 | Asthenia | |
| 931953212 | 9319532 | Catheter site pruritus | |
| 931953212 | 9319532 | Decreased appetite | |
| 931953212 | 9319532 | Device breakage | |
| 931953212 | 9319532 | Device related infection | |
| 931953212 | 9319532 | Diarrhoea | |
| 931953212 | 9319532 | Flushing | |
| 931953212 | 9319532 | Hospitalisation | |
| 931953212 | 9319532 | Incorrect dose administered | |
| 931953212 | 9319532 | Infection | |
| 931953212 | 9319532 | Musculoskeletal pain | |
| 931953212 | 9319532 | Nausea | |
| 931953212 | 9319532 | Pain in jaw | |
| 931953212 | 9319532 | Papule | |
| 931953212 | 9319532 | Sepsis | |
| 931953212 | 9319532 | Unevaluable event | |
| 931953212 | 9319532 | Vomiting | |
| 931953212 | 9319532 | Weight decreased | |
| 931953212 | 9319532 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 931953212 | 9319532 | 1 | 20090806 | 0 | ||
| 931953212 | 9319532 | 2 | 20090806 | 0 | ||
| 931953212 | 9319532 | 3 | 20090806 | 0 | ||
| 931953212 | 9319532 | 4 | 20090814 | 0 | ||
| 931953212 | 9319532 | 6 | 20090814 | 0 | ||
| 931953212 | 9319532 | 9 | 20090814 | 0 | ||
| 931953212 | 9319532 | 10 | 20090814 | 0 | ||
| 931953212 | 9319532 | 11 | 20090814 | 0 |