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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126601421 | 12660142 | 1 | I | 2016 | 20160816 | 20160817 | 20160817 | PER | US-009507513-1608USA008830 | MERCK | 52.00 | YR | F | Y | 148.30000 | KG | 20160817 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126601421 | 12660142 | 1 | PS | PRINIVIL | LISINOPRIL | 1 | Oral | UNK | Y | 19558 | TABLET | ||||||||
| 126601421 | 12660142 | 2 | SS | TYVASO | TREPROSTINIL | 1 | Respiratory (inhalation) | 18-54 MICROGRAM, QID | U | 0 | INHALATION GAS | QID | |||||||
| 126601421 | 12660142 | 3 | SS | TYVASO | TREPROSTINIL | 1 | Respiratory (inhalation) | UNK | U | 0 | INHALATION GAS | ||||||||
| 126601421 | 12660142 | 4 | SS | TYVASO | TREPROSTINIL | 1 | Respiratory (inhalation) | UNK | U | 0 | INHALATION GAS | ||||||||
| 126601421 | 12660142 | 5 | SS | TYVASO | TREPROSTINIL | 1 | Respiratory (inhalation) | 6 - 9 BREATHS | U | 0 | INHALATION GAS | ||||||||
| 126601421 | 12660142 | 6 | C | OPSUMIT | MACITENTAN | 1 | 0 | ||||||||||||
| 126601421 | 12660142 | 7 | C | ADCIRCA | TADALAFIL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126601421 | 12660142 | 1 | Product used for unknown indication |
| 126601421 | 12660142 | 2 | Pulmonary arterial hypertension |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126601421 | 12660142 | Cough | |
| 126601421 | 12660142 | Dizziness postural | |
| 126601421 | 12660142 | Dry mouth | |
| 126601421 | 12660142 | Dyspnoea | |
| 126601421 | 12660142 | Fluid retention | |
| 126601421 | 12660142 | Flushing | |
| 126601421 | 12660142 | Headache | |
| 126601421 | 12660142 | Hypotension | |
| 126601421 | 12660142 | Oedema peripheral |
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 |
|---|---|---|---|---|---|---|
| 126601421 | 12660142 | 1 | 201605 | 0 | ||
| 126601421 | 12660142 | 2 | 20160418 | 0 |