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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126916051 | 12691605 | 1 | I | 201607 | 20160804 | 20160826 | 20160826 | EXP | US-GLAXOSMITHKLINE-US2016GSK117734 | GLAXOSMITHKLINE | 77.00 | YR | F | Y | 0.00000 | 20160826 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126916051 | 12691605 | 1 | SS | Ambrisentan | AMBRISENTAN | 1 | 5 MG, QD | 1413180A | 0 | 5 | MG | TABLET | QD | ||||||
| 126916051 | 12691605 | 2 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | 20444 | |||||||||||
| 126916051 | 12691605 | 3 | SS | PROSTACYCLIN | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 126916051 | 12691605 | 4 | C | ATORVASTATIN | ATORVASTATIN | 1 | 0 | ||||||||||||
| 126916051 | 12691605 | 5 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | 0 | ||||||||||||
| 126916051 | 12691605 | 6 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | 0 | ||||||||||||
| 126916051 | 12691605 | 7 | C | PULMICORT TURBUHALER | BUDESONIDE | 1 | 0 | ||||||||||||
| 126916051 | 12691605 | 8 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126916051 | 12691605 | 9 | C | ERGOCALCIFEROL. | ERGOCALCIFEROL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126916051 | 12691605 | 1 | Pulmonary hypertension |
| 126916051 | 12691605 | 2 | Product used for unknown indication |
| 126916051 | 12691605 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126916051 | 12691605 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126916051 | 12691605 | Headache | |
| 126916051 | 12691605 | Nausea | |
| 126916051 | 12691605 | Oedema | |
| 126916051 | 12691605 | Pain in jaw |
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 |
|---|---|---|---|---|---|---|
| 126916051 | 12691605 | 1 | 20160721 | 0 |