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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 910561211 | 9105612 | 11 | F | 20110223 | 20160729 | 20130221 | 20160803 | EXP | US-GLAXOSMITHKLINE-A0919029A | GLAXOSMITHKLINE | 43.45 | YR | M | Y | 66.00000 | KG | 20160803 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 910561211 | 9105612 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 50 NG/KG/MIN54 NG/KG/MIN60 NG/KG/MIN, CONCENTRATION 75,000 NG/ML, PUMP RATE 82 ML/DAY, VIAL STR[...] | U | H578 | 20444 | 50 | DF | POWDER FOR INFUSION | |||||
| 910561211 | 9105612 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | C592216 | 20444 | POWDER FOR INFUSION | ||||||||
| 910561211 | 9105612 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N644 | 20444 | POWDER FOR INFUSION | ||||||||
| 910561211 | 9105612 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S706 | 20444 | POWDER FOR INFUSION | ||||||||
| 910561211 | 9105612 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S501 | 20444 | POWDER FOR INFUSION | ||||||||
| 910561211 | 9105612 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | UNK, CO | U | T794 | 20444 | POWDER FOR INFUSION | |||||||
| 910561211 | 9105612 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 56 NG/KG/MIN, CO | U | V378 | 20444 | POWDER FOR INFUSION | ||||||||
| 910561211 | 9105612 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 56 NG/KG/MIN, CO | U | V785 | 20444 | 56 | DF | POWDER FOR INFUSION | ||||||
| 910561211 | 9105612 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 41 NG/KG/MIN (CONCENTRATION 45,000 NG/ML, PUMP RATE 93 ML/DAY, VIAL STRENGTH 1.5 MG), CO | U | Z606 | 0 | SOLUTION FOR INJECTION | |||||||
| 910561211 | 9105612 | 10 | SS | REMERON | MIRTAZAPINE | 1 | 45 MG, U | U | 0 | 45 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 910561211 | 9105612 | 1 | Pulmonary arterial hypertension |
| 910561211 | 9105612 | 9 | Pulmonary arterial hypertension |
| 910561211 | 9105612 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 910561211 | 9105612 | OT |
| 910561211 | 9105612 | HO |
| 910561211 | 9105612 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 910561211 | 9105612 | Catheter site erythema | |
| 910561211 | 9105612 | Catheter site infection | |
| 910561211 | 9105612 | Cellulitis | |
| 910561211 | 9105612 | Constipation | |
| 910561211 | 9105612 | Cough | |
| 910561211 | 9105612 | Dehydration | |
| 910561211 | 9105612 | Dyspnoea | |
| 910561211 | 9105612 | Headache | |
| 910561211 | 9105612 | Hypotension | |
| 910561211 | 9105612 | Incorrect dose administered | |
| 910561211 | 9105612 | Infusion site infection | |
| 910561211 | 9105612 | Nausea | |
| 910561211 | 9105612 | Overdose | |
| 910561211 | 9105612 | Pneumonia | |
| 910561211 | 9105612 | Prescribed overdose | |
| 910561211 | 9105612 | Vomiting | |
| 910561211 | 9105612 | 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 |
|---|---|---|---|---|---|---|
| 910561211 | 9105612 | 1 | 20020517 | 0 | ||
| 910561211 | 9105612 | 2 | 20020517 | 0 | ||
| 910561211 | 9105612 | 3 | 20020517 | 0 | ||
| 910561211 | 9105612 | 4 | 20020517 | 0 | ||
| 910561211 | 9105612 | 5 | 20020517 | 0 | ||
| 910561211 | 9105612 | 6 | 20020514 | 0 | ||
| 910561211 | 9105612 | 7 | 20020508 | 0 | ||
| 910561211 | 9105612 | 8 | 20020508 | 0 | ||
| 910561211 | 9105612 | 9 | 20020505 | 0 |