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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122179896 | 12217989 | 6 | F | 20160528 | 20160808 | 20160329 | 20160817 | PER | US-ACTELION PHARMACEUTICALS US, INC.-A-NJ2016-133183 | ACTELION | 53.00 | YR | A | F | Y | 0.00000 | 20160817 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122179896 | 12217989 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | UM016A0201 | 204410 | 10 | MG | TABLET | QD | |||||
| 122179896 | 12217989 | 2 | SS | DICLOFENAC SODIUM. | DICLOFENAC SODIUM | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122179896 | 12217989 | 1 | Pulmonary arterial hypertension |
| 122179896 | 12217989 | 2 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122179896 | 12217989 | Arthralgia | |
| 122179896 | 12217989 | Chest discomfort | |
| 122179896 | 12217989 | Chest pain | |
| 122179896 | 12217989 | Condition aggravated | |
| 122179896 | 12217989 | Confusional state | |
| 122179896 | 12217989 | Deformity thorax | |
| 122179896 | 12217989 | Dizziness | |
| 122179896 | 12217989 | Drug dose omission | |
| 122179896 | 12217989 | Dyspnoea | |
| 122179896 | 12217989 | Fluid retention | |
| 122179896 | 12217989 | Hypoaesthesia | |
| 122179896 | 12217989 | Memory impairment | |
| 122179896 | 12217989 | Pain | |
| 122179896 | 12217989 | Peripheral coldness | |
| 122179896 | 12217989 | Pulmonary arterial hypertension | |
| 122179896 | 12217989 | Rib fracture | |
| 122179896 | 12217989 | Road traffic accident | |
| 122179896 | 12217989 | Stress | |
| 122179896 | 12217989 | Syncope | |
| 122179896 | 12217989 | Therapeutic response decreased | |
| 122179896 | 12217989 | Therapy non-responder | |
| 122179896 | 12217989 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 122179896 | 12217989 | 1 | 20160218 | 0 |