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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1095850317 | 10958503 | 17 | F | 20151015 | 20160926 | 20150326 | 20160930 | EXP | US-GLAXOSMITHKLINE-US2015GSK039530 | GLAXOSMITHKLINE | 55.14 | YR | M | Y | 0.00000 | 20160930 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1095850317 | 10958503 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 41.5 NG/KG/MIN CONTINUOUSLY | U | U052 | 20444 | 41.5 | DF | POWDER FOR INFUSION | |||||
| 1095850317 | 10958503 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 75,000 NG/ML, PUMP RATE 77 ML/DAY, VIAL STRENGTH 1.5 MG), CO | U | U202 | 20444 | POWDER FOR INFUSION | |||||||
| 1095850317 | 10958503 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 41.5 NG/KG/MIN CONTINUOUSLY | U | U202 | 20444 | 41.5 | DF | POWDER FOR INFUSION | ||||||
| 1095850317 | 10958503 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 22 NG/KG/MIN CONTINUOUS | U | V380 | 20444 | 22 | DF | POWDER FOR INFUSION | |||||
| 1095850317 | 10958503 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 50 NG/KG/MIN (CONCENTRATION 75,000 NG/ML, PUMP RATE 93 ML/DAY, VIAL STRENGTH 1.5), CO | U | V380 | 20444 | POWDER FOR INFUSION | |||||||
| 1095850317 | 10958503 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 50 NG/KG/MIN CONTINUOUS | U | W674 | 20444 | 50 | DF | POWDER FOR INFUSION | ||||||
| 1095850317 | 10958503 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 50 NG/KG/MIN (CONCENTRATION 75,000 NG/ML, PUMP RATE 93 ML/DAY, VIAL STRENGTH 1.5 MG), CO | U | Z606 | 20444 | POWDER FOR INFUSION | ||||||||
| 1095850317 | 10958503 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 50 NG/KG/MIN CONTINUOUSLY | U | Z880 | 20444 | 50 | DF | POWDER FOR INFUSION | |||||
| 1095850317 | 10958503 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 50 NG/KG/MIN, CO | U | C7764454 | 20444 | 50 | DF | POWDER FOR INFUSION | |||||
| 1095850317 | 10958503 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | C760234 | 0 | SOLUTION FOR INJECTION | ||||||||
| 1095850317 | 10958503 | 11 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | 0 | SOLUTION FOR INJECTION | ||||||||||
| 1095850317 | 10958503 | 12 | SS | XARELTO | RIVAROXABAN | 1 | N | 0 | |||||||||||
| 1095850317 | 10958503 | 13 | C | TRACLEER | BOSENTAN | 1 | U | 0 | |||||||||||
| 1095850317 | 10958503 | 14 | C | ADCIRCA | TADALAFIL | 1 | U | 0 | |||||||||||
| 1095850317 | 10958503 | 15 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1095850317 | 10958503 | 1 | Pulmonary arterial hypertension |
| 1095850317 | 10958503 | 2 | Pulmonary arterial hypertension |
| 1095850317 | 10958503 | 10 | Pulmonary arterial hypertension |
| 1095850317 | 10958503 | 11 | Pulmonary arterial hypertension |
| 1095850317 | 10958503 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1095850317 | 10958503 | HO |
| 1095850317 | 10958503 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1095850317 | 10958503 | Adverse drug reaction | |
| 1095850317 | 10958503 | Atrial fibrillation | |
| 1095850317 | 10958503 | Catheter management | |
| 1095850317 | 10958503 | Catheter site discharge | |
| 1095850317 | 10958503 | Catheter site erythema | |
| 1095850317 | 10958503 | Catheter site infection | |
| 1095850317 | 10958503 | Catheter site pain | |
| 1095850317 | 10958503 | Device related infection | |
| 1095850317 | 10958503 | Gastrointestinal haemorrhage | |
| 1095850317 | 10958503 | Haematochezia | |
| 1095850317 | 10958503 | Haemorrhage | |
| 1095850317 | 10958503 | Headache | |
| 1095850317 | 10958503 | Pain in extremity | |
| 1095850317 | 10958503 | Pain in jaw | |
| 1095850317 | 10958503 | Pancreatitis acute | |
| 1095850317 | 10958503 | Portal hypertensive gastropathy | |
| 1095850317 | 10958503 | Syncope | |
| 1095850317 | 10958503 | Therapeutic procedure |
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 |
|---|---|---|---|---|---|---|
| 1095850317 | 10958503 | 1 | 20070320 | 0 | ||
| 1095850317 | 10958503 | 6 | 20070321 | 0 | ||
| 1095850317 | 10958503 | 8 | 20070321 | 0 | ||
| 1095850317 | 10958503 | 10 | 20070321 | 0 |