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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 961100314 | 9611003 | 14 | F | 20140109 | 20160627 | 20131009 | 20160706 | EXP | US-GLAXOSMITHKLINE-A1044643A | GLAXOSMITHKLINE | 49.24 | YR | F | Y | 48.60000 | KG | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 961100314 | 9611003 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | DOSE 76 NG/KG/MIN, CONCENTRATION 75,000 NG/ML, PUMP RATE 79 ML/DAY, VIAL STRENGTH 1.5 MGREDUCED[...] | P508 | 20444 | POWDER FOR INFUSION | ||||||||
| 961100314 | 9611003 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | R271A | 20444 | POWDER FOR INFUSION | |||||||||
| 961100314 | 9611003 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 71 NG/KG/MIN CONTINUOUS; CONCENTRATION: 75,000 NG/ML; PUMP RATE: 74 ML/DAY; VIAL STRENGTH: 1.5 MG | T366 | 20444 | POWDER FOR INFUSION | ||||||||
| 961100314 | 9611003 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | UNK, CO | U893 | 20444 | POWDER FOR INFUSION | ||||||||
| 961100314 | 9611003 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | UNK, CO | U893 | 20444 | POWDER FOR INFUSION | ||||||||
| 961100314 | 9611003 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 71 DF, CO | V926 | 20444 | 71 | DF | POWDER FOR INFUSION | ||||||
| 961100314 | 9611003 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 22 DF, CO | V926 | 20444 | 22 | DF | POWDER FOR INFUSION | |||||||
| 961100314 | 9611003 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 71 DF, CO | V926 | 20444 | 71 | DF | POWDER FOR INFUSION | |||||||
| 961100314 | 9611003 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 71 DF, CO | V926 | 20444 | 71 | DF | POWDER FOR INFUSION | ||||||
| 961100314 | 9611003 | 10 | C | ADCIRCA | TADALAFIL | 1 | U | 0 | |||||||||||
| 961100314 | 9611003 | 11 | C | LETAIRIS | AMBRISENTAN | 1 | U | 0 | |||||||||||
| 961100314 | 9611003 | 12 | C | WARFARIN | WARFARIN | 1 | U | 0 | |||||||||||
| 961100314 | 9611003 | 13 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 961100314 | 9611003 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 961100314 | 9611003 | DE |
| 961100314 | 9611003 | HO |
| 961100314 | 9611003 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 961100314 | 9611003 | Bronchial haemorrhage | |
| 961100314 | 9611003 | Death | |
| 961100314 | 9611003 | Diarrhoea | |
| 961100314 | 9611003 | Headache | |
| 961100314 | 9611003 | Hospitalisation | |
| 961100314 | 9611003 | Incorrect dose administered | |
| 961100314 | 9611003 | Living in residential institution | |
| 961100314 | 9611003 | Mechanical ventilation | |
| 961100314 | 9611003 | Nasopharyngitis | |
| 961100314 | 9611003 | Urinary tract infection | |
| 961100314 | 9611003 | Vascular injury | |
| 961100314 | 9611003 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 961100314 | 9611003 | 1 | 20000920 | 0 | ||
| 961100314 | 9611003 | 3 | 20000920 | 0 | ||
| 961100314 | 9611003 | 4 | 20000920 | 0 | ||
| 961100314 | 9611003 | 5 | 20000920 | 0 | ||
| 961100314 | 9611003 | 6 | 20000920 | 0 | ||
| 961100314 | 9611003 | 7 | 20000929 | 0 | ||
| 961100314 | 9611003 | 8 | 20000929 | 0 | ||
| 961100314 | 9611003 | 9 | 20000920 | 0 |