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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 918612219 | 9186122 | 19 | F | 20120530 | 20160720 | 20130325 | 20160727 | EXP | US-GLAXOSMITHKLINE-A0975028A | GLAXOSMITHKLINE | 72.70 | YR | F | Y | 0.00000 | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 918612219 | 9186122 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 50 NG/KG/MIN, CONCENTRATION 75000 NG/ML, PUMP RATE 79 ML/DAY (VIAL STRENGTH 1.5) | C551020 | 20444 | 50 | DF | POWDER FOR INFUSION | ||||||
| 918612219 | 9186122 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | M100 | 20444 | POWDER FOR INFUSION | |||||||||
| 918612219 | 9186122 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | N437 | 20444 | POWDER FOR INFUSION | |||||||||
| 918612219 | 9186122 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | N848 | 20444 | POWDER FOR INFUSION | |||||||||
| 918612219 | 9186122 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | N849 | 20444 | POWDER FOR INFUSION | |||||||||
| 918612219 | 9186122 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 50 NG/KG/MIN CONTINUOUSLY; 75,000 NG/ML; PUMP RATE: 79 ML/DAY; VIAL STRENGTH: 1.5 MG | U052 | 20444 | POWDER FOR INFUSION | |||||||||
| 918612219 | 9186122 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 50NG/KG/MIN | V049 | 20444 | POWDER FOR INFUSION | |||||||||
| 918612219 | 9186122 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | UNK, CO | V380 | 20444 | POWDER FOR INFUSION | ||||||||
| 918612219 | 9186122 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 50 NG/KG/MIN CONTINUOUS | V380 | 20444 | 50 | DF | POWDER FOR INFUSION | ||||||
| 918612219 | 9186122 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 50 NG/KG/MIN, CO | V380 | 20444 | POWDER FOR INFUSION | |||||||||
| 918612219 | 9186122 | 11 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 50 NG/KG/MIN CONTINUOUSLY; 75,000 NG/ML; PUMP RATE: 79 ML/DAY; VIAL STRENGTH: 1.5 MG | V380 | 20444 | POWDER FOR INFUSION | |||||||||
| 918612219 | 9186122 | 12 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 50 NG/KG/MIN CONTINOUS | U052 | 20444 | 50 | DF | POWDER FOR INFUSION | |||||||
| 918612219 | 9186122 | 13 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 50 NG/KG/MIN (CONCENTRATION 75,000 NG/ML, PUMP RATE 79 ML/DAY, VIAL STRENGTH 1.5 MG/ML) CO | W674 | 20444 | POWDER FOR INFUSION | ||||||||
| 918612219 | 9186122 | 14 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 50 NG/KG/MIN CONTINOUS | Z606 | 20444 | 50 | DF | POWDER FOR INFUSION | |||||||
| 918612219 | 9186122 | 15 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 918612219 | 9186122 | 16 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 918612219 | 9186122 | 17 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 918612219 | 9186122 | 18 | C | ALDACTONE | SPIRONOLACTONE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 918612219 | 9186122 | 1 | Pulmonary arterial hypertension |
| 918612219 | 9186122 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 918612219 | 9186122 | OT |
| 918612219 | 9186122 | DE |
| 918612219 | 9186122 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 918612219 | 9186122 | Anaemia | |
| 918612219 | 9186122 | Application site erythema | |
| 918612219 | 9186122 | Application site pruritus | |
| 918612219 | 9186122 | Cardiac ablation | |
| 918612219 | 9186122 | Cardiac pacemaker insertion | |
| 918612219 | 9186122 | Chest discomfort | |
| 918612219 | 9186122 | Chest pain | |
| 918612219 | 9186122 | Complication associated with device | |
| 918612219 | 9186122 | Death | |
| 918612219 | 9186122 | Dermatitis contact | |
| 918612219 | 9186122 | Device malfunction | |
| 918612219 | 9186122 | Diarrhoea | |
| 918612219 | 9186122 | Dizziness | |
| 918612219 | 9186122 | Drug dose omission | |
| 918612219 | 9186122 | Dysphagia | |
| 918612219 | 9186122 | Dyspnoea | |
| 918612219 | 9186122 | Fluid overload | |
| 918612219 | 9186122 | Heart rate abnormal | |
| 918612219 | 9186122 | Hospitalisation | |
| 918612219 | 9186122 | Hyperhidrosis | |
| 918612219 | 9186122 | Mobility decreased | |
| 918612219 | 9186122 | Musculoskeletal pain | |
| 918612219 | 9186122 | Oropharyngeal pain | |
| 918612219 | 9186122 | Pallor | |
| 918612219 | 9186122 | Rash | |
| 918612219 | 9186122 | Seasonal allergy | |
| 918612219 | 9186122 | Syncope | |
| 918612219 | 9186122 | Therapy cessation | |
| 918612219 | 9186122 | Thrombosis in device | |
| 918612219 | 9186122 | Transfusion |
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 |
|---|---|---|---|---|---|---|
| 918612219 | 9186122 | 1 | 20030825 | 0 | ||
| 918612219 | 9186122 | 2 | 20030825 | 0 | ||
| 918612219 | 9186122 | 3 | 20030825 | 0 | ||
| 918612219 | 9186122 | 4 | 20030825 | 0 | ||
| 918612219 | 9186122 | 5 | 20030825 | 0 | ||
| 918612219 | 9186122 | 6 | 20030919 | 0 | ||
| 918612219 | 9186122 | 7 | 20030918 | 0 | ||
| 918612219 | 9186122 | 8 | 20030918 | 0 | ||
| 918612219 | 9186122 | 10 | 20030918 | 0 | ||
| 918612219 | 9186122 | 11 | 20030918 | 0 | ||
| 918612219 | 9186122 | 12 | 20030918 | 0 | ||
| 918612219 | 9186122 | 14 | 20030918 | 0 |