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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122390494 | 12239049 | 4 | F | 20160322 | 20160818 | 20160405 | 20160823 | PER | US-ACTELION PHARMACEUTICALS US, INC.-A-US2016-133762 | ACTELION | 81.00 | YR | E | M | Y | 0.00000 | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122390494 | 12239049 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP019P0101,OP021P0101,OP023P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 122390494 | 12239049 | 2 | SS | RIOCIGUAT | RIOCIGUAT | 1 | Unknown | 1.5 MG, TID | U | U | 0 | 1.5 | MG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122390494 | 12239049 | 1 | Pulmonary hypertension |
| 122390494 | 12239049 | 2 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122390494 | 12239049 | Asthenia | |
| 122390494 | 12239049 | Burning sensation | |
| 122390494 | 12239049 | Contusion | |
| 122390494 | 12239049 | Diarrhoea | |
| 122390494 | 12239049 | Fall | |
| 122390494 | 12239049 | Fatigue | |
| 122390494 | 12239049 | Feeling abnormal | |
| 122390494 | 12239049 | Insomnia | |
| 122390494 | 12239049 | Malaise | |
| 122390494 | 12239049 | Migraine | |
| 122390494 | 12239049 | Pain | |
| 122390494 | 12239049 | Rib fracture |
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 |
|---|---|---|---|---|---|---|
| 122390494 | 12239049 | 1 | 20130314 | 0 | ||
| 122390494 | 12239049 | 2 | 20160718 | 0 |