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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 964923821 | 9649238 | 21 | F | 2014 | 20160804 | 20131028 | 20160811 | EXP | US-GLAXOSMITHKLINE-A1043151A | GLAXOSMITHKLINE | 43.19 | YR | F | Y | 0.00000 | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 964923821 | 9649238 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 12 NG/KG/MIN, CONCENTRATION 30,000 NG/ML, VIAL STRENGTH 1.5 MG14 NG/KG/MIN18 NG/KG/MIN, PUMP RA[...] | P508 | 20444 | 24 | DF | POWDER FOR INFUSION | ||||||
| 964923821 | 9649238 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | P828 | 20444 | POWDER FOR INFUSION | |||||||||
| 964923821 | 9649238 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | R614 | 20444 | POWDER FOR INFUSION | |||||||||
| 964923821 | 9649238 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | S706 | 20444 | POWDER FOR INFUSION | |||||||||
| 964923821 | 9649238 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 30 NG/KG/MIN CONTINUOUSLY | S922 | 20444 | POWDER FOR INFUSION | |||||||||
| 964923821 | 9649238 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 30 NG/KG/MIN CONTINUOUSLY; CONCENTRATION: 45,000 NG/ML; PUMP RATE: 91 ML/DAY; VIAL STRENGTH: 1.5 MG | T366 | 20444 | POWDER FOR INFUSION | ||||||||
| 964923821 | 9649238 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 30 NG/KG/MIN CONTINUOUS | T662 | 20444 | 30 | DF | POWDER FOR INFUSION | |||||||
| 964923821 | 9649238 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 30 NG/KG/MIN CONTINUOUS | U631 | 20444 | POWDER FOR INFUSION | |||||||||
| 964923821 | 9649238 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 30 NG/KG/MIN CONTINUOUS,CONCENTRATION OF 45,000 NG/ML, PUMP RATE 91 ML/DAY AND 1.5 VIAL STRENGTH | V049 | 20444 | 30 | DF | POWDER FOR INFUSION | |||||||
| 964923821 | 9649238 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 22 NG/KG/MIN CONTINUOUS | V785 | 20444 | 22 | DF | POWDER FOR INFUSION | ||||||
| 964923821 | 9649238 | 11 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | VIAL STRENGTH 1.5 MG, DOSE 30 NG/KG/MIN, CONCENTARTION 45 NG/ML, PUMP RATE 91 ML/DAY | V785 | 20444 | 30 | DF | POWDER FOR INFUSION | ||||||
| 964923821 | 9649238 | 12 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 30 NG/KG/MIN CONTINUOUSLY | V934 | 20444 | 30 | DF | POWDER FOR INFUSION | |||||||
| 964923821 | 9649238 | 13 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 30 NG/KG/MIN CONTINUOUSLY;45,000 NG/ML CONCENTRATION; 91 ML/DAY;VIAL STRENGTH 1.5 MG | W674 | 20444 | 30 | DF | POWDER FOR INFUSION | ||||||
| 964923821 | 9649238 | 14 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 30 NG/KG/MIN, CO | Z606 | 20444 | 30 | DF | POWDER FOR INFUSION | ||||||
| 964923821 | 9649238 | 15 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 30 NG/KG/MIN, CO | Z606 | 20444 | POWDER FOR INFUSION | |||||||||
| 964923821 | 9649238 | 16 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 30 NG/KG/MIN CONTINUOUSLY; CONCENTRATION: 45,000 NG/ML; PUMP RATE: 91 ML/DAY; VIAL STRENGTH: 1.5 MG | Z606 | 20444 | POWDER FOR INFUSION | ||||||||
| 964923821 | 9649238 | 17 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 0 | SOLUTION FOR INJECTION | |||||||||||
| 964923821 | 9649238 | 18 | C | REVATIO | SILDENAFIL CITRATE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 964923821 | 9649238 | 1 | Pulmonary hypertension |
| 964923821 | 9649238 | 2 | Cor pulmonale chronic |
| 964923821 | 9649238 | 3 | Pulmonary arterial hypertension |
| 964923821 | 9649238 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 964923821 | 9649238 | DE |
| 964923821 | 9649238 | OT |
| 964923821 | 9649238 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 964923821 | 9649238 | Administration site erythema | |
| 964923821 | 9649238 | Anaemia | |
| 964923821 | 9649238 | Bronchitis | |
| 964923821 | 9649238 | Cardiac failure congestive | |
| 964923821 | 9649238 | Catheter placement | |
| 964923821 | 9649238 | Catheter site discharge | |
| 964923821 | 9649238 | Chest pain | |
| 964923821 | 9649238 | Cognitive disorder | |
| 964923821 | 9649238 | Death | |
| 964923821 | 9649238 | Diarrhoea | |
| 964923821 | 9649238 | Dyspnoea | |
| 964923821 | 9649238 | Eating disorder | |
| 964923821 | 9649238 | Fall | |
| 964923821 | 9649238 | Fatigue | |
| 964923821 | 9649238 | Fluid overload | |
| 964923821 | 9649238 | Headache | |
| 964923821 | 9649238 | Hospitalisation | |
| 964923821 | 9649238 | Ill-defined disorder | |
| 964923821 | 9649238 | Infection | |
| 964923821 | 9649238 | Nasopharyngitis | |
| 964923821 | 9649238 | Nausea | |
| 964923821 | 9649238 | Pleural effusion | |
| 964923821 | 9649238 | Pneumonia | |
| 964923821 | 9649238 | Pulmonary arterial hypertension | |
| 964923821 | 9649238 | Renal impairment | |
| 964923821 | 9649238 | Respiratory tract infection | |
| 964923821 | 9649238 | Rhinorrhoea | |
| 964923821 | 9649238 | Scleroderma | |
| 964923821 | 9649238 | Sinusitis | |
| 964923821 | 9649238 | Somnolence | |
| 964923821 | 9649238 | Spinal fracture | |
| 964923821 | 9649238 | Tachycardia | |
| 964923821 | 9649238 | Transfusion | |
| 964923821 | 9649238 | Vomiting | |
| 964923821 | 9649238 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 964923821 | 9649238 | 1 | 20130725 | 0 | ||
| 964923821 | 9649238 | 2 | 20130725 | 0 | ||
| 964923821 | 9649238 | 3 | 20130725 | 0 | ||
| 964923821 | 9649238 | 4 | 20130725 | 0 | ||
| 964923821 | 9649238 | 15 | 20130731 | 0 | ||
| 964923821 | 9649238 | 16 | 20130731 | 0 |