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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 928370613 | 9283706 | 13 | F | 20130502 | 20160822 | 20130510 | 20160824 | EXP | US-GLAXOSMITHKLINE-A1023099A | GLAXOSMITHKLINE | 44.77 | YR | F | Y | 105.00000 | KG | 20160824 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 928370613 | 9283706 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | CONCENTRATION 105,000 NG/MLVIAL 1.5 MG53.5 NG/KG/MIN, 1.5 MG VIAL STRENGTH, 105,000 NG/ML CONC,[...] | U | N644 | 20444 | 54.5 | DF | POWDER FOR INFUSION | |||||
| 928370613 | 9283706 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S706 | 20444 | POWDER FOR INFUSION | ||||||||
| 928370613 | 9283706 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 53.5 NG/KG/MIN | U | T274 | 20444 | POWDER FOR INFUSION | ||||||||
| 928370613 | 9283706 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 56 DF, CO | U | Z606 | 20444 | 56 | DF | POWDER FOR INFUSION | ||||||
| 928370613 | 9283706 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 56 NG/KG/MIN CONTINUOUS | U | Z606 | 20444 | 56 | DF | POWDER FOR INFUSION | |||||
| 928370613 | 9283706 | 6 | C | LETAIRIS | AMBRISENTAN | 1 | U | 0 | |||||||||||
| 928370613 | 9283706 | 7 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 928370613 | 9283706 | 8 | C | SILDENAFIL. | SILDENAFIL | 1 | 0 | ||||||||||||
| 928370613 | 9283706 | 9 | C | LASIX | FUROSEMIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 928370613 | 9283706 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 928370613 | 9283706 | HO |
| 928370613 | 9283706 | LT |
| 928370613 | 9283706 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 928370613 | 9283706 | Abdominal discomfort | |
| 928370613 | 9283706 | Dizziness | |
| 928370613 | 9283706 | Fluid retention | |
| 928370613 | 9283706 | Haemoglobin decreased | |
| 928370613 | 9283706 | Hospitalisation | |
| 928370613 | 9283706 | Large intestinal haemorrhage | |
| 928370613 | 9283706 | Pneumonia | |
| 928370613 | 9283706 | Pyrexia | |
| 928370613 | 9283706 | Rectal haemorrhage | |
| 928370613 | 9283706 | Transfusion |
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 |
|---|---|---|---|---|---|---|
| 928370613 | 9283706 | 1 | 20080801 | 0 | ||
| 928370613 | 9283706 | 2 | 20080801 | 0 | ||
| 928370613 | 9283706 | 3 | 20080801 | 0 | ||
| 928370613 | 9283706 | 5 | 20100628 | 0 |