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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125809061 | 12580906 | 1 | I | 20150801 | 20160715 | 20160721 | 20160721 | EXP | GB-MHRA-EYC 00142187 | GB-CONCORDIA PHARMACEUTICALS INC.-GSH201607-003675 | CONCORDIA | 71.00 | YR | M | Y | 74.60000 | KG | 20160721 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125809061 | 12580906 | 1 | PS | DIGOXIN. | DIGOXIN | 1 | Oral | Y | U | 20405 | |||||||||
| 125809061 | 12580906 | 2 | SS | DIGOXIN. | DIGOXIN | 1 | Intravenous (not otherwise specified) | Y | U | 20405 | |||||||||
| 125809061 | 12580906 | 3 | C | WARFARIN | WARFARIN | 1 | Oral | 0 | |||||||||||
| 125809061 | 12580906 | 4 | C | BISOPROLOL | BISOPROLOL | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125809061 | 12580906 | 1 | Atrial fibrillation |
| 125809061 | 12580906 | 2 | Atrial fibrillation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125809061 | 12580906 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125809061 | 12580906 | Acute kidney injury | |
| 125809061 | 12580906 | Dermatitis exfoliative | |
| 125809061 | 12580906 | Liver injury | |
| 125809061 | 12580906 | Malaise | |
| 125809061 | 12580906 | Rash | |
| 125809061 | 12580906 | Skin reaction |
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 |
|---|---|---|---|---|---|---|
| 125809061 | 12580906 | 1 | 20150401 | 0 |