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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 853244013 | 8532440 | 13 | F | 20120405 | 20160919 | 20120426 | 20160922 | EXP | US-GLAXOSMITHKLINE-A0975015A | GLAXOSMITHKLINE | 42.60 | YR | F | Y | 0.00000 | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 853244013 | 8532440 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 20 NG/KG/MIN, CONCENTRATION 30,000 NG/ML AT 94 ML/DAY, VIAL STRENGTH 1.5 MGCONTINUOUS | U | L005 | 20444 | 20 | DF | POWDER FOR INFUSION | |||||
| 853244013 | 8532440 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | M240 | 20444 | POWDER FOR INFUSION | ||||||||
| 853244013 | 8532440 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N388 | 20444 | POWDER FOR INFUSION | ||||||||
| 853244013 | 8532440 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N644 | 20444 | POWDER FOR INFUSION | ||||||||
| 853244013 | 8532440 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 20 NG/KG/MIN CONTINUOUS; CONCENTRATION 30,000 NG/ML AT 94 ML/DAY; VIAL STRENGTH 1.5 MG | U | T366 | 20444 | POWDER FOR INFUSION | |||||||
| 853244013 | 8532440 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 20 NG/KG/MIN | U | T794 | 20444 | 20 | DF | POWDER FOR INFUSION | |||||
| 853244013 | 8532440 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 20 NG/KG/MIN | U | T794 | 20444 | POWDER FOR INFUSION | ||||||||
| 853244013 | 8532440 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 20 NG/KG/MIN CONTINUOUS | U | Z880 | 20444 | 20 | DF | POWDER FOR INFUSION | |||||
| 853244013 | 8532440 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | UNK | U | C760234 | 0 | SOLUTION FOR INJECTION | |||||||
| 853244013 | 8532440 | 10 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 853244013 | 8532440 | 11 | C | LETAIRIS | AMBRISENTAN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 853244013 | 8532440 | 1 | Cor pulmonale chronic |
| 853244013 | 8532440 | 2 | Pulmonary hypertension |
| 853244013 | 8532440 | 9 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 853244013 | 8532440 | OT |
| 853244013 | 8532440 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 853244013 | 8532440 | Ankle fracture | |
| 853244013 | 8532440 | Catheter site discharge | |
| 853244013 | 8532440 | Catheter site haemorrhage | |
| 853244013 | 8532440 | Catheter site infection | |
| 853244013 | 8532440 | Catheter site pain | |
| 853244013 | 8532440 | Clostridium difficile infection | |
| 853244013 | 8532440 | Complication associated with device | |
| 853244013 | 8532440 | Device related infection | |
| 853244013 | 8532440 | Gastric infection | |
| 853244013 | 8532440 | Hospitalisation | |
| 853244013 | 8532440 | Influenza | |
| 853244013 | 8532440 | Infusion site infection | |
| 853244013 | 8532440 | Loss of consciousness | |
| 853244013 | 8532440 | Nasopharyngitis | |
| 853244013 | 8532440 | Nausea | |
| 853244013 | 8532440 | Nocturnal dyspnoea | |
| 853244013 | 8532440 | Pain | |
| 853244013 | 8532440 | Pancreatic disorder | |
| 853244013 | 8532440 | Pancreatitis chronic | |
| 853244013 | 8532440 | Syncope | |
| 853244013 | 8532440 | Vomiting | |
| 853244013 | 8532440 | Weight fluctuation |
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 |
|---|---|---|---|---|---|---|
| 853244013 | 8532440 | 1 | 20080919 | 0 | ||
| 853244013 | 8532440 | 2 | 20080919 | 0 | ||
| 853244013 | 8532440 | 3 | 20080919 | 0 | ||
| 853244013 | 8532440 | 4 | 20080919 | 0 | ||
| 853244013 | 8532440 | 7 | 20080924 | 0 | ||
| 853244013 | 8532440 | 8 | 20080924 | 0 | ||
| 853244013 | 8532440 | 9 | 20080924 | 0 |