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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127619661 | 12761966 | 1 | I | 20160512 | 20160906 | 20160920 | 20160920 | EXP | GB-AUROBINDO-AUR-APL-2016-11470 | AUROBINDO | 50.00 | YR | M | Y | 0.00000 | 20160920 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127619661 | 12761966 | 1 | PS | Bisoprolol | BISOPROLOL | 1 | Unknown | U | U | 77910 | |||||||||
| 127619661 | 12761966 | 2 | SS | AMIODARONE | AMIODARONE | 1 | Unknown | U | U | 0 | |||||||||
| 127619661 | 12761966 | 3 | SS | APIXABAN | APIXABAN | 1 | Unknown | U | U | 0 | |||||||||
| 127619661 | 12761966 | 4 | SS | DIAZEPAM. | DIAZEPAM | 1 | Unknown | U | U | 0 | |||||||||
| 127619661 | 12761966 | 5 | SS | HEPARIN | HEPARIN SODIUM | 1 | Intravenous (not otherwise specified) | Y | U | 0 | SOLUTION FOR INFUSION | ||||||||
| 127619661 | 12761966 | 6 | SS | MONOPARIN | HEPARIN SODIUM | 1 | Subcutaneous | 5000 IU/0.2ML | Y | U | 0 | .2 | ML |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127619661 | 12761966 | 1 | Product used for unknown indication |
| 127619661 | 12761966 | 2 | Product used for unknown indication |
| 127619661 | 12761966 | 3 | Product used for unknown indication |
| 127619661 | 12761966 | 4 | Product used for unknown indication |
| 127619661 | 12761966 | 5 | Product used for unknown indication |
| 127619661 | 12761966 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127619661 | 12761966 | HO |
| 127619661 | 12761966 | LT |
| 127619661 | 12761966 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127619661 | 12761966 | Asthenia | |
| 127619661 | 12761966 | Atrial fibrillation | |
| 127619661 | 12761966 | Back pain | |
| 127619661 | 12761966 | Cardiac failure | |
| 127619661 | 12761966 | Complication associated with device | |
| 127619661 | 12761966 | Discomfort | |
| 127619661 | 12761966 | General physical condition abnormal | |
| 127619661 | 12761966 | Heart rate abnormal | |
| 127619661 | 12761966 | Hepatic failure | |
| 127619661 | 12761966 | Insomnia | |
| 127619661 | 12761966 | Internal haemorrhage | |
| 127619661 | 12761966 | Jaundice | |
| 127619661 | 12761966 | Malaise | |
| 127619661 | 12761966 | Monoplegia | |
| 127619661 | 12761966 | Muscle haemorrhage | |
| 127619661 | 12761966 | Poor peripheral circulation | |
| 127619661 | 12761966 | Productive cough | |
| 127619661 | 12761966 | Pyrexia | |
| 127619661 | 12761966 | Renal failure | |
| 127619661 | 12761966 | Sensory disturbance | |
| 127619661 | 12761966 | Septic rash | |
| 127619661 | 12761966 | Septic shock | |
| 127619661 | 12761966 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 127619661 | 12761966 | 5 | 20160512 | 0 | ||
| 127619661 | 12761966 | 6 | 20160512 | 20160615 | 0 |