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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116846138 | 11684613 | 8 | F | 20160705 | 20151029 | 20160712 | PER | US-ACTELION PHARMACEUTICALS US, INC.-A-US2015-126402 | ACTELION | 55.00 | YR | A | F | Y | 0.00000 | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116846138 | 11684613 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | UM017N0201,UM016A0201,UM016A0301 | 204410 | 10 | MG | TABLET | QD | |||||
| 116846138 | 11684613 | 2 | SS | TREPROSTINIL DIOLAMIN | TREPROSTINIL DIOLAMINE | 1 | Unknown | 2.5 MG, TID | 0 | 2.5 | MG | TID | |||||||
| 116846138 | 11684613 | 3 | SS | TREPROSTINIL DIOLAMIN | TREPROSTINIL DIOLAMINE | 1 | Unknown | 2.375 MG, TID | 0 | 2.375 | MG | TID | |||||||
| 116846138 | 11684613 | 4 | SS | TREPROSTINIL DIOLAMIN | TREPROSTINIL DIOLAMINE | 1 | Unknown | 2.625 MG, TID | 0 | 2.625 | MG | TID | |||||||
| 116846138 | 11684613 | 5 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | U | 0 | ||||||||||
| 116846138 | 11684613 | 6 | C | ADCIRCA | TADALAFIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116846138 | 11684613 | 1 | Pulmonary arterial hypertension |
| 116846138 | 11684613 | 2 | Product used for unknown indication |
| 116846138 | 11684613 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116846138 | 11684613 | Accidental overdose | |
| 116846138 | 11684613 | Diarrhoea | |
| 116846138 | 11684613 | Dizziness | |
| 116846138 | 11684613 | Dry skin | |
| 116846138 | 11684613 | Dyspnoea | |
| 116846138 | 11684613 | Headache | |
| 116846138 | 11684613 | Malaise | |
| 116846138 | 11684613 | Nausea | |
| 116846138 | 11684613 | Pain in jaw | |
| 116846138 | 11684613 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 116846138 | 11684613 | 1 | 20141217 | 0 |