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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127814801 | 12781480 | 1 | I | 20150702 | 20160926 | 20160926 | EXP | US-ACTELION-A-US2015-120748 | ACTELION | 42.00 | YR | A | M | Y | 0.00000 | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127814801 | 12781480 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, UNK | OP026P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 127814801 | 12781480 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | UNK | IP054P0101,OP019P0101 | 21290 | TABLET | ||||||||
| 127814801 | 12781480 | 3 | SS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 23 NG/KG, PER MIN | MM054M001,MM074M0101 | 22260 | INJECTION | /min | |||||||
| 127814801 | 12781480 | 4 | SS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 41 NG/KG, PER MIN | MM090M0101 | 22260 | INJECTION | /min | |||||||
| 127814801 | 12781480 | 5 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 | |||||||||||
| 127814801 | 12781480 | 6 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127814801 | 12781480 | 1 | Pulmonary hypertension |
| 127814801 | 12781480 | 3 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127814801 | 12781480 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127814801 | 12781480 | Abdominal discomfort | |
| 127814801 | 12781480 | Decreased appetite | |
| 127814801 | 12781480 | Diarrhoea | |
| 127814801 | 12781480 | Feeling abnormal | |
| 127814801 | 12781480 | Flushing | |
| 127814801 | 12781480 | Gastrointestinal disorder | |
| 127814801 | 12781480 | Hypersensitivity | |
| 127814801 | 12781480 | Insomnia | |
| 127814801 | 12781480 | Irritability | |
| 127814801 | 12781480 | Memory impairment | |
| 127814801 | 12781480 | Nausea | |
| 127814801 | 12781480 | Oedema | |
| 127814801 | 12781480 | Restlessness | |
| 127814801 | 12781480 | 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 |
|---|---|---|---|---|---|---|
| 127814801 | 12781480 | 1 | 20160113 | 0 | ||
| 127814801 | 12781480 | 4 | 20150224 | 0 |