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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126438731 | 12643873 | 1 | I | 20160720 | 20160805 | 20160811 | 20160811 | EXP | GB-MHRA-EYC 00143174 | GB-CONCORDIA PHARMACEUTICALS INC.-GSH201608-003993 | CONCORDIA | 94.00 | YR | F | Y | 60.00000 | KG | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126438731 | 12643873 | 1 | PS | DIGOXIN. | DIGOXIN | 1 | Oral | U | 20405 | QD | |||||||||
| 126438731 | 12643873 | 2 | SS | DIGOXIN. | DIGOXIN | 1 | Oral | LOADING DOSE | U | 20405 | |||||||||
| 126438731 | 12643873 | 3 | SS | BUMETANIDE. | BUMETANIDE | 1 | DOSE INCREASED ON THIS DATE | U | 0 | ||||||||||
| 126438731 | 12643873 | 4 | C | ATORVASTATIN | ATORVASTATIN | 1 | 0 | ||||||||||||
| 126438731 | 12643873 | 5 | C | FERROUS FUMARATE | FERROUS FUMARATE | 1 | 0 | ||||||||||||
| 126438731 | 12643873 | 6 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | ||||||||||||
| 126438731 | 12643873 | 7 | C | PREGABALIN. | PREGABALIN | 1 | 0 | ||||||||||||
| 126438731 | 12643873 | 8 | C | QUININE | QUININE | 1 | HELD | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126438731 | 12643873 | 1 | Atrial fibrillation |
| 126438731 | 12643873 | 2 | Atrial fibrillation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126438731 | 12643873 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126438731 | 12643873 | Acute kidney injury | |
| 126438731 | 12643873 | Bradycardia | |
| 126438731 | 12643873 | Confusional state | |
| 126438731 | 12643873 | Incorrect dose administered | |
| 126438731 | 12643873 | Toxicity to various agents |
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 |
|---|---|---|---|---|---|---|
| 126438731 | 12643873 | 1 | 20160710 | 20160720 | 0 | |
| 126438731 | 12643873 | 3 | 20160710 | 0 |