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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120108795 | 12010879 | 5 | F | 20160119 | 20160711 | 20160205 | 20160722 | PER | US-ACTELION-A-US2016-130823 | ACTELION | 58.00 | YR | A | M | Y | 0.00000 | 20160723 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120108795 | 12010879 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | 21290 | 125 | MG | TABLET | BID | ||||||
| 120108795 | 12010879 | 2 | SS | GABAPENTIN. | GABAPENTIN | 1 | Unknown | Y | U | 0 | |||||||||
| 120108795 | 12010879 | 3 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 | |||||||||||
| 120108795 | 12010879 | 4 | C | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 124 NG/KG, PER MIN | 0 | /min | |||||||||
| 120108795 | 12010879 | 5 | C | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 136 NG/KG, PER MIN | 0 | /min | |||||||||
| 120108795 | 12010879 | 6 | C | RIOCIGUAT | RIOCIGUAT | 1 | 1.5 MG, TID | 0 | 1.5 | MG | TID | ||||||||
| 120108795 | 12010879 | 7 | C | POTASSIUM | POTASSIUM | 1 | U | 0 | |||||||||||
| 120108795 | 12010879 | 8 | C | REQUIP | ROPINIROLE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 120108795 | 12010879 | 9 | C | RYTHMOL | PROPAFENONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 120108795 | 12010879 | 10 | C | WARFARIN | WARFARIN | 1 | U | 0 | |||||||||||
| 120108795 | 12010879 | 11 | C | ROPINIROLE. | ROPINIROLE | 1 | U | 0 | |||||||||||
| 120108795 | 12010879 | 12 | C | PREDNISONE. | PREDNISONE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120108795 | 12010879 | 1 | Pulmonary arterial hypertension |
| 120108795 | 12010879 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120108795 | 12010879 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120108795 | 12010879 | Ascites | |
| 120108795 | 12010879 | Dyspnoea | |
| 120108795 | 12010879 | Fall | |
| 120108795 | 12010879 | Hallucination | |
| 120108795 | 12010879 | Local swelling | |
| 120108795 | 12010879 | Nausea | |
| 120108795 | 12010879 | Neck injury | |
| 120108795 | 12010879 | Oedema | |
| 120108795 | 12010879 | Oedema peripheral | |
| 120108795 | 12010879 | Pain | |
| 120108795 | 12010879 | Respiratory distress | |
| 120108795 | 12010879 | Somnolence | |
| 120108795 | 12010879 | Swelling | |
| 120108795 | 12010879 | Swelling face |
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 |
|---|---|---|---|---|---|---|
| 120108795 | 12010879 | 1 | 20020419 | 0 | ||
| 120108795 | 12010879 | 4 | 201601 | 0 | ||
| 120108795 | 12010879 | 5 | 201601 | 0 | ||
| 120108795 | 12010879 | 6 | 20160506 | 0 |