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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97265375 | 9726537 | 5 | F | 201307 | 20160923 | 20131203 | 20160928 | EXP | US-GLAXOSMITHKLINE-A1037194A | GLAXOSMITHKLINE | 50.51 | YR | F | Y | 0.00000 | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97265375 | 9726537 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Unknown | CONCENTRATION: 60,000 NG/MLVIAL STRENGTH: 1.5 MGPUMP RATE: 54 ML/DAY | D | P267 | 20444 | 44.12 | DF | POWDER FOR INFUSION | |||||
| 97265375 | 9726537 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | D | P508 | 20444 | POWDER FOR INFUSION | ||||||||
| 97265375 | 9726537 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | D | P828 | 20444 | POWDER FOR INFUSION | ||||||||
| 97265375 | 9726537 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 44.6 DF, CO | D | Z880 | 20444 | 44.6 | DF | POWDER FOR INFUSION | |||||
| 97265375 | 9726537 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 45.95 NG/KG/MIN | D | J171 | 20444 | 45.95 | DF | POWDER FOR INFUSION | ||||||
| 97265375 | 9726537 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | D | C760234 | 0 | SOLUTION FOR INJECTION | ||||||||
| 97265375 | 9726537 | 7 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | N | 0 | ||||||||||
| 97265375 | 9726537 | 8 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 97265375 | 9726537 | 9 | C | LETAIRIS | AMBRISENTAN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 97265375 | 9726537 | 1 | Cor pulmonale chronic |
| 97265375 | 9726537 | 2 | Pulmonary hypertension |
| 97265375 | 9726537 | 6 | Pulmonary hypertension |
| 97265375 | 9726537 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 97265375 | 9726537 | OT |
| 97265375 | 9726537 | DE |
| 97265375 | 9726537 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 97265375 | 9726537 | Arthralgia | |
| 97265375 | 9726537 | Asthenia | |
| 97265375 | 9726537 | Back pain | |
| 97265375 | 9726537 | Death | |
| 97265375 | 9726537 | Device malfunction | |
| 97265375 | 9726537 | Dyspnoea | |
| 97265375 | 9726537 | Feeling abnormal | |
| 97265375 | 9726537 | Fluid retention | |
| 97265375 | 9726537 | Gastrointestinal disorder | |
| 97265375 | 9726537 | Insomnia | |
| 97265375 | 9726537 | Medical device removal | |
| 97265375 | 9726537 | Swelling | |
| 97265375 | 9726537 | Underdose | |
| 97265375 | 9726537 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 97265375 | 9726537 | 1 | 20060923 | 0 | ||
| 97265375 | 9726537 | 2 | 20060923 | 0 | ||
| 97265375 | 9726537 | 3 | 20060923 | 0 | ||
| 97265375 | 9726537 | 5 | 20060923 | 0 | ||
| 97265375 | 9726537 | 7 | 201309 | 0 |