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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 931956714 | 9319567 | 14 | F | 20121225 | 20160705 | 20130530 | 20160708 | EXP | US-GLAXOSMITHKLINE-A1007344A | GLAXOSMITHKLINE | 42.26 | YR | F | Y | 55.40000 | KG | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 931956714 | 9319567 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 142 NG/KG/MIN, CO | Y | N644 | 20444 | 142 | DF | POWDER FOR INFUSION | |||||
| 931956714 | 9319567 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | UNK, CO | Y | S506 | 20444 | POWDER FOR INFUSION | |||||||
| 931956714 | 9319567 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | UNK, CO | Y | T620 | 20444 | POWDER FOR INFUSION | |||||||
| 931956714 | 9319567 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 142 NG/KG/MIN CONTINUOUSLY | Y | T662 | 20444 | 142 | DF | POWDER FOR INFUSION | |||||
| 931956714 | 9319567 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 142 NG/KG/MIN (CONCENTRATION 135,000 NG/ML, PUMP RATE 88 ML/DAY, VIAL STRENGTH 1.5 MG/ML), CO | Y | U631 | 20444 | POWDER FOR INFUSION | |||||||
| 931956714 | 9319567 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 142 NG/KG/MIN | Y | V785 | 20444 | 142 | DF | POWDER FOR INFUSION | ||||||
| 931956714 | 9319567 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 142 NG/KG/MIN CONTINUOUS | Y | W663 | 20444 | 142 | DF | POWDER FOR INFUSION | ||||||
| 931956714 | 9319567 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 142 NG/KG/MIN CONTINUOUS | Y | Z606 | 20444 | 142 | DF | POWDER FOR INFUSION | ||||||
| 931956714 | 9319567 | 9 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 931956714 | 9319567 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 931956714 | 9319567 | OT |
| 931956714 | 9319567 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 931956714 | 9319567 | Abdominal distension | |
| 931956714 | 9319567 | Abdominal pain | |
| 931956714 | 9319567 | Abdominal tenderness | |
| 931956714 | 9319567 | Aortic arteriosclerosis | |
| 931956714 | 9319567 | Back pain | |
| 931956714 | 9319567 | Bile duct stenosis | |
| 931956714 | 9319567 | Biliary dilatation | |
| 931956714 | 9319567 | Cardiac failure congestive | |
| 931956714 | 9319567 | Catheter site erythema | |
| 931956714 | 9319567 | Chest pain | |
| 931956714 | 9319567 | Cholangiocarcinoma | |
| 931956714 | 9319567 | Constipation | |
| 931956714 | 9319567 | Device breakage | |
| 931956714 | 9319567 | Dyspnoea exertional | |
| 931956714 | 9319567 | Ear infection | |
| 931956714 | 9319567 | Gastroenteritis viral | |
| 931956714 | 9319567 | Haemangioma of spleen | |
| 931956714 | 9319567 | Hospitalisation | |
| 931956714 | 9319567 | Influenza | |
| 931956714 | 9319567 | Interstitial lung disease | |
| 931956714 | 9319567 | Lipoma | |
| 931956714 | 9319567 | Liver disorder | |
| 931956714 | 9319567 | Lower respiratory tract infection | |
| 931956714 | 9319567 | Lymph gland infection | |
| 931956714 | 9319567 | Lymphadenopathy | |
| 931956714 | 9319567 | Neoplasm | |
| 931956714 | 9319567 | Nephrolithiasis | |
| 931956714 | 9319567 | Pancreatic pseudocyst | |
| 931956714 | 9319567 | Pneumonia | |
| 931956714 | 9319567 | Portal vein stenosis | |
| 931956714 | 9319567 | Pyrexia | |
| 931956714 | 9319567 | Skin warm | |
| 931956714 | 9319567 | Tympanic membrane perforation | |
| 931956714 | 9319567 | Vitamin B12 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 |
|---|---|---|---|---|---|---|
| 931956714 | 9319567 | 1 | 20001022 | 0 | ||
| 931956714 | 9319567 | 2 | 20001022 | 0 | ||
| 931956714 | 9319567 | 3 | 20001022 | 0 | ||
| 931956714 | 9319567 | 6 | 20001022 | 0 | ||
| 931956714 | 9319567 | 7 | 20001022 | 0 | ||
| 931956714 | 9319567 | 8 | 20001022 | 0 |