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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123867584 | 12386758 | 4 | F | 20160912 | 20160519 | 20160923 | EXP | US-ACTELION-A-NJ2016-136280 | ACTELION | 57.00 | YR | A | F | Y | 61.40000 | KG | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123867584 | 12386758 | 1 | PS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 28 NG/KG, PER MIN | Y | MM083M0101,MM091M0101 | 22260 | INJECTION | /min | ||||||
| 123867584 | 12386758 | 2 | SS | REGLAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Oral | 10 MG, UNK | Y | 0 | 10 | MG | |||||||
| 123867584 | 12386758 | 3 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 | |||||||||||
| 123867584 | 12386758 | 4 | C | LETAIRIS | AMBRISENTAN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123867584 | 12386758 | 1 | Pulmonary arterial hypertension |
| 123867584 | 12386758 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123867584 | 12386758 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123867584 | 12386758 | Chest discomfort | |
| 123867584 | 12386758 | Device alarm issue | |
| 123867584 | 12386758 | Diarrhoea | |
| 123867584 | 12386758 | Dizziness | |
| 123867584 | 12386758 | Dyspnoea | |
| 123867584 | 12386758 | Hernia repair | |
| 123867584 | 12386758 | Lung disorder | |
| 123867584 | 12386758 | Malaise | |
| 123867584 | 12386758 | Nasopharyngitis | |
| 123867584 | 12386758 | Nausea | |
| 123867584 | 12386758 | Overdose | |
| 123867584 | 12386758 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 123867584 | 12386758 | 1 | 20131204 | 0 | ||
| 123867584 | 12386758 | 2 | 20160511 | 0 |