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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1067159021 | 10671590 | 21 | F | 20130906 | 20160701 | 20141223 | 20160707 | EXP | US-GLAXOSMITHKLINE-US2014GSK040252 | GLAXOSMITHKLINE | 62.33 | YR | F | Y | 112.93000 | KG | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1067159021 | 10671590 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | R113 | 20444 | POWDER FOR INFUSION | ||||||||
| 1067159021 | 10671590 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 11 NG/KG/MIN | U | T366 | 20444 | POWDER FOR INFUSION | ||||||||
| 1067159021 | 10671590 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 11 NG/KG/MIN CONTINUOUS; CONCENTRATION: 30,000 NG/ML; PUMP RATE: 61 ML/DAY; VIAL STRENGTH: 1.5 MG,CO | U | T662 | 20444 | POWDER FOR INFUSION | |||||||
| 1067159021 | 10671590 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 17 NG/KG/MIN CONTINUOUS; CONCENTRATION: 45,000 NG/ML; PUMP RATE: 63 ML/DAY; VIAL STRENGTH: 1.5 MG,CO | U | T794 | 20444 | POWDER FOR INFUSION | |||||||
| 1067159021 | 10671590 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK, CO | U | T856 | 20444 | POWDER FOR INFUSION | ||||||||
| 1067159021 | 10671590 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 21 NG/KG/MIN | U | T856 | 20444 | POWDER FOR INFUSION | |||||||
| 1067159021 | 10671590 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK, CO | U | U631 | 20444 | POWDER FOR INFUSION | ||||||||
| 1067159021 | 10671590 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | 20444 | POWDER FOR INFUSION | |||||||||
| 1067159021 | 10671590 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 30 NG/KG/MIN, CO | U | U631 | 20444 | POWDER FOR INFUSION | ||||||||
| 1067159021 | 10671590 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK, CO | U | V049 | 20444 | POWDER FOR INFUSION | ||||||||
| 1067159021 | 10671590 | 11 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK, CO | U | V378 | 20444 | POWDER FOR INFUSION | ||||||||
| 1067159021 | 10671590 | 12 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 36 DF, CO | U | V785 | 20444 | 36 | DF | POWDER FOR INFUSION | ||||||
| 1067159021 | 10671590 | 13 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | UNK, CO | U | Z111 | 20444 | POWDER FOR INFUSION | |||||||
| 1067159021 | 10671590 | 14 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 36 NG/KG/MIN (CONCENTRATION 75,000 NG/ML, PUMP RATE 80 ML/DAY, VIAL STRENGTH 1.5 MG), CO | U | Z606 | 20444 | POWDER FOR INFUSION | ||||||||
| 1067159021 | 10671590 | 15 | SS | ADEMPAS | RIOCIGUAT | 1 | 0.5 MG, TID | Y | 0 | .5 | MG | TID | |||||||
| 1067159021 | 10671590 | 16 | SS | ADEMPAS | RIOCIGUAT | 1 | 0.5 MG, QD | Y | 0 | .5 | MG | QD | |||||||
| 1067159021 | 10671590 | 17 | SS | ADEMPAS | RIOCIGUAT | 1 | 0.5 MG, BID | Y | 0 | .5 | MG | BID | |||||||
| 1067159021 | 10671590 | 18 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 1067159021 | 10671590 | 19 | C | NORVASC | AMLODIPINE BESYLATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1067159021 | 10671590 | 1 | Pulmonary arterial hypertension |
| 1067159021 | 10671590 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1067159021 | 10671590 | HO |
| 1067159021 | 10671590 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1067159021 | 10671590 | Adverse event | |
| 1067159021 | 10671590 | Blister | |
| 1067159021 | 10671590 | Blood pressure increased | |
| 1067159021 | 10671590 | Catheter site discharge | |
| 1067159021 | 10671590 | Catheter site erythema | |
| 1067159021 | 10671590 | Catheter site extravasation | |
| 1067159021 | 10671590 | Catheter site haemorrhage | |
| 1067159021 | 10671590 | Catheter site pain | |
| 1067159021 | 10671590 | Central venous catheter removal | |
| 1067159021 | 10671590 | Central venous catheterisation | |
| 1067159021 | 10671590 | Chest discomfort | |
| 1067159021 | 10671590 | Choking sensation | |
| 1067159021 | 10671590 | Complication associated with device | |
| 1067159021 | 10671590 | Cough | |
| 1067159021 | 10671590 | Dermatitis contact | |
| 1067159021 | 10671590 | Device breakage | |
| 1067159021 | 10671590 | Device leakage | |
| 1067159021 | 10671590 | Device malfunction | |
| 1067159021 | 10671590 | Diarrhoea | |
| 1067159021 | 10671590 | Dizziness | |
| 1067159021 | 10671590 | Drug administration error | |
| 1067159021 | 10671590 | Drug dose omission | |
| 1067159021 | 10671590 | Drug intolerance | |
| 1067159021 | 10671590 | Dyspnoea | |
| 1067159021 | 10671590 | Emergency care | |
| 1067159021 | 10671590 | Erythema | |
| 1067159021 | 10671590 | Feeling hot | |
| 1067159021 | 10671590 | Flushing | |
| 1067159021 | 10671590 | Headache | |
| 1067159021 | 10671590 | Hospitalisation | |
| 1067159021 | 10671590 | Malaise | |
| 1067159021 | 10671590 | Nausea | |
| 1067159021 | 10671590 | Neuropathy peripheral | |
| 1067159021 | 10671590 | Ocular discomfort | |
| 1067159021 | 10671590 | Pain in extremity | |
| 1067159021 | 10671590 | Pain in jaw | |
| 1067159021 | 10671590 | Palpitations | |
| 1067159021 | 10671590 | Pneumonia | |
| 1067159021 | 10671590 | Rash generalised | |
| 1067159021 | 10671590 | Restless legs syndrome | |
| 1067159021 | 10671590 | Upper respiratory tract infection | |
| 1067159021 | 10671590 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 1067159021 | 10671590 | 1 | 20141209 | 0 | ||
| 1067159021 | 10671590 | 3 | 20141209 | 0 | ||
| 1067159021 | 10671590 | 4 | 20141209 | 0 | ||
| 1067159021 | 10671590 | 6 | 20141214 | 0 | ||
| 1067159021 | 10671590 | 7 | 20141212 | 0 | ||
| 1067159021 | 10671590 | 9 | 20141212 | 0 | ||
| 1067159021 | 10671590 | 12 | 20141212 | 0 |