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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126548493 | 12654849 | 3 | F | 20160718 | 20160822 | 20160816 | 20160826 | EXP | US-GLAXOSMITHKLINE-US2016GSK117298 | GLAXOSMITHKLINE | 57.39 | YR | F | Y | 0.00000 | 20160826 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126548493 | 12654849 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 39.4 NG/KG/MIN, CO | Z880 | 20444 | 39.4 | DF | POWDER FOR INFUSION | |||||||
| 126548493 | 12654849 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | C876654 | 0 | SOLUTION FOR INJECTION | |||||||||
| 126548493 | 12654849 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | C764454 | 0 | SOLUTION FOR INJECTION | |||||||||
| 126548493 | 12654849 | 4 | C | TRACLEER | BOSENTAN | 1 | U | 0 | |||||||||||
| 126548493 | 12654849 | 5 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 126548493 | 12654849 | 6 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126548493 | 12654849 | 1 | Pulmonary arterial hypertension |
| 126548493 | 12654849 | 2 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126548493 | 12654849 | DE |
| 126548493 | 12654849 | HO |
| 126548493 | 12654849 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126548493 | 12654849 | Catheterisation cardiac | |
| 126548493 | 12654849 | Death | |
| 126548493 | 12654849 | Hospitalisation | |
| 126548493 | 12654849 | Pulmonary hypertension | |
| 126548493 | 12654849 | Therapeutic procedure |
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 |
|---|---|---|---|---|---|---|
| 126548493 | 12654849 | 1 | 19991011 | 0 |