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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127216411 | 12721641 | 1 | I | 20100622 | 20101210 | 20160907 | 20160907 | EXP | US-SANOFI-AVENTIS-2010SA075680 | AVENTIS | 54.00 | YR | A | F | Y | 65.90000 | KG | 20160907 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127216411 | 12721641 | 1 | PS | MULTAQ | DRONEDARONE | 1 | Oral | N | UNKNOWN | 22425 | 400 | MG | TABLET | BID | |||||
| 127216411 | 12721641 | 2 | SS | MULTAQ | DRONEDARONE | 1 | Oral | N | UNKNOWN | 22425 | 400 | MG | TABLET | QD | |||||
| 127216411 | 12721641 | 3 | C | ASPIRIN. | ASPIRIN | 1 | 0 | 325 | MG | QD | |||||||||
| 127216411 | 12721641 | 4 | C | ATENOLOL. | ATENOLOL | 1 | 0 | 12.5 | MG | BID | |||||||||
| 127216411 | 12721641 | 5 | C | ACIPHEX | RABEPRAZOLE SODIUM | 1 | 0 | 20 | MG | QD | |||||||||
| 127216411 | 12721641 | 6 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 127216411 | 12721641 | 7 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127216411 | 12721641 | 1 | Atrial fibrillation |
| 127216411 | 12721641 | 2 | Atrial fibrillation |
| 127216411 | 12721641 | 3 | Atrial fibrillation |
| 127216411 | 12721641 | 4 | Cardiac disorder |
| 127216411 | 12721641 | 5 | Gastrooesophageal reflux disease |
| 127216411 | 12721641 | 6 | Headache |
| 127216411 | 12721641 | 7 | Muscle spasms |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127216411 | 12721641 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127216411 | 12721641 | Abdominal pain lower | |
| 127216411 | 12721641 | Asthenia | Asthenia |
| 127216411 | 12721641 | Blood potassium decreased | |
| 127216411 | 12721641 | Blood pressure decreased | |
| 127216411 | 12721641 | Condition aggravated | |
| 127216411 | 12721641 | Decreased appetite | |
| 127216411 | 12721641 | Dehydration | |
| 127216411 | 12721641 | Diarrhoea | Diarrhoea |
| 127216411 | 12721641 | Diarrhoea | |
| 127216411 | 12721641 | Dyspnoea | |
| 127216411 | 12721641 | Faeces discoloured | |
| 127216411 | 12721641 | Fatigue | |
| 127216411 | 12721641 | Gastritis | |
| 127216411 | 12721641 | Gastrooesophageal reflux disease | |
| 127216411 | 12721641 | Heart rate irregular | |
| 127216411 | 12721641 | Hypophagia | |
| 127216411 | 12721641 | Impaired gastric emptying | |
| 127216411 | 12721641 | Insomnia | |
| 127216411 | 12721641 | Malaise | |
| 127216411 | 12721641 | Nausea | |
| 127216411 | 12721641 | Oesophageal discomfort | |
| 127216411 | 12721641 | Oesophageal spasm | |
| 127216411 | 12721641 | Weight 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 |
|---|---|---|---|---|---|---|
| 127216411 | 12721641 | 1 | 201004 | 201006 | 0 | |
| 127216411 | 12721641 | 2 | 201006 | 201007 | 0 | |
| 127216411 | 12721641 | 3 | 2007 | 0 | ||
| 127216411 | 12721641 | 4 | 2008 | 0 | ||
| 127216411 | 12721641 | 5 | 2007 | 0 |