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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 101556065 | 10155606 | 5 | F | 20140406 | 20160815 | 20140506 | 20160822 | EXP | US-GLAXOSMITHKLINE-A0886814A | GLAXOSMITHKLINE | 58.46 | YR | F | Y | 51.00000 | KG | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 101556065 | 10155606 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 34 NG/KG/MIN, CONCENTRATION 45,000 NG/ML, PUMP RATE 66 ML PER DAY, 1.5 MG VIAL STRENGTH | U | R271A | 20444 | 29.5 | DF | POWDER FOR INJECTION | |||||
| 101556065 | 10155606 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S276 | 20444 | POWDER FOR INJECTION | ||||||||
| 101556065 | 10155606 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S706 | 20444 | POWDER FOR INJECTION | ||||||||
| 101556065 | 10155606 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S553 | 20444 | POWDER FOR INJECTION | ||||||||
| 101556065 | 10155606 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 34 NG/KG/MIN, CONCENTRATION 45,000 NG/ML, PUMP RATE 66 ML PER DAY, 1.5 MG VIAL STRENGTH, CO | U | S707 | 20444 | POWDER FOR INJECTION | ||||||||
| 101556065 | 10155606 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 34 NG/KG/MIN, CO | U | Z111 | 20444 | 34 | DF | POWDER FOR INJECTION | |||||
| 101556065 | 10155606 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | 0 | SOLUTION FOR INJECTION | ||||||||||
| 101556065 | 10155606 | 8 | C | DIGOXIN. | DIGOXIN | 1 | Oral | U | 0 | 125 | UG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 101556065 | 10155606 | 1 | Cor pulmonale chronic |
| 101556065 | 10155606 | 2 | Pulmonary hypertension |
| 101556065 | 10155606 | 7 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 101556065 | 10155606 | OT |
| 101556065 | 10155606 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 101556065 | 10155606 | Alopecia | |
| 101556065 | 10155606 | Catheter removal | |
| 101556065 | 10155606 | Central venous catheter removal | |
| 101556065 | 10155606 | Central venous catheterisation | |
| 101556065 | 10155606 | Cough | |
| 101556065 | 10155606 | Device dislocation | |
| 101556065 | 10155606 | Device malfunction | |
| 101556065 | 10155606 | Diarrhoea | |
| 101556065 | 10155606 | Flushing | |
| 101556065 | 10155606 | Hospitalisation | |
| 101556065 | 10155606 | Pain in extremity | |
| 101556065 | 10155606 | Swelling | |
| 101556065 | 10155606 | Therapy cessation |
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 |
|---|---|---|---|---|---|---|
| 101556065 | 10155606 | 1 | 20071005 | 0 | ||
| 101556065 | 10155606 | 2 | 20071005 | 0 | ||
| 101556065 | 10155606 | 3 | 20071005 | 0 | ||
| 101556065 | 10155606 | 4 | 20071005 | 0 | ||
| 101556065 | 10155606 | 5 | 20071113 | 0 |