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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123963613 | 12396361 | 3 | F | 20160418 | 20160915 | 20160524 | 20160920 | EXP | DE-BFARM-16166912 | DE-009507513-1605DEU010425 | MERCK | 45.00 | YR | M | Y | 99.00000 | KG | 20160920 | CN | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123963613 | 12396361 | 1 | PS | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | UNK | Y | U | 20829 | TABLET | ||||||||
| 123963613 | 12396361 | 2 | SS | OMALIZUMAB | OMALIZUMAB | 1 | UNK | Y | U | 0 | |||||||||
| 123963613 | 12396361 | 3 | C | FLECAINIDE | FLECAINIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123963613 | 12396361 | 1 | Asthma |
| 123963613 | 12396361 | 2 | Asthma |
| 123963613 | 12396361 | 3 | Tachycardia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123963613 | 12396361 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123963613 | 12396361 | Arrhythmia supraventricular | |
| 123963613 | 12396361 | Endocarditis fibroplastica | |
| 123963613 | 12396361 | Eosinophilic granulomatosis with polyangiitis | |
| 123963613 | 12396361 | Hypereosinophilic syndrome | |
| 123963613 | 12396361 | Myocarditis | |
| 123963613 | 12396361 | Pulmonary function test decreased |
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 |
|---|---|---|---|---|---|---|
| 123963613 | 12396361 | 1 | 2016 | 0 | ||
| 123963613 | 12396361 | 2 | 20160328 | 2016 | 0 |