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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125759884 | 12575988 | 4 | F | 20160620 | 20160808 | 20160720 | 20160811 | EXP | US-GILEAD-2016-0219175 | GILEAD | 72.00 | YR | E | F | Y | 0.00000 | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125759884 | 12575988 | 1 | PS | AMBRISENTAN | AMBRISENTAN | 1 | Unknown | 5 MG, UNK | 90 | MG | Y | 22081 | 5 | MG | TABLET | ||||
| 125759884 | 12575988 | 2 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Unknown | 10 MG, QD | 90 | MG | Y | 1504768A | 22081 | 10 | MG | TABLET | QD | ||
| 125759884 | 12575988 | 3 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | 40 MG, QD | 240 | MG | Y | 0 | 40 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125759884 | 12575988 | 1 | Pulmonary arterial hypertension |
| 125759884 | 12575988 | 3 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125759884 | 12575988 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125759884 | 12575988 | Dyspnoea | |
| 125759884 | 12575988 | Ear discomfort | |
| 125759884 | 12575988 | Eyelid oedema | |
| 125759884 | 12575988 | Headache | |
| 125759884 | 12575988 | Lacrimation increased | |
| 125759884 | 12575988 | Nasal congestion | |
| 125759884 | 12575988 | Nasal oedema | |
| 125759884 | 12575988 | Oedema peripheral | |
| 125759884 | 12575988 | Oxygen saturation decreased | |
| 125759884 | 12575988 | Panic attack | |
| 125759884 | 12575988 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 125759884 | 12575988 | 1 | 20160609 | 0 | ||
| 125759884 | 12575988 | 2 | 20160614 | 20160720 | 0 | |
| 125759884 | 12575988 | 3 | 20160617 | 20160719 | 0 |