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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126460391 | 12646039 | 1 | I | 2015 | 20160802 | 20160811 | 20160811 | PER | US-AMGEN-USASL2016100792 | AMGEN | 64.00 | YR | A | F | Y | 0.00000 | 20160811 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126460391 | 12646039 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | 25 MG, QWK | U | 103795 | 25 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 126460391 | 12646039 | 2 | SS | MELATONIN | MELATONIN | 1 | Unknown | 1 MG, UNK | 0 | 1 | MG | ||||||||
| 126460391 | 12646039 | 3 | SS | MELATONIN | MELATONIN | 1 | Unknown | 2 MG, UNK | 0 | 2 | MG | ||||||||
| 126460391 | 12646039 | 4 | SS | MELATONIN | MELATONIN | 1 | Unknown | 3 MG, UNK | 0 | 3 | MG | ||||||||
| 126460391 | 12646039 | 5 | SS | LUNESTA | ESZOPICLONE | 1 | Unknown | 5 MG, UNK | 0 | 5 | MG | ||||||||
| 126460391 | 12646039 | 6 | SS | LUNESTA | ESZOPICLONE | 1 | Unknown | 10 MG, UNK | 0 | 10 | MG | ||||||||
| 126460391 | 12646039 | 7 | SS | AMBIEN | ZOLPIDEM TARTRATE | 1 | Unknown | 5 MG, UNK | 0 | 5 | MG | ||||||||
| 126460391 | 12646039 | 8 | SS | AMBIEN | ZOLPIDEM TARTRATE | 1 | Unknown | 10 MG, UNK | 0 | 10 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126460391 | 12646039 | 1 | Rheumatoid arthritis |
| 126460391 | 12646039 | 2 | Product used for unknown indication |
| 126460391 | 12646039 | 5 | Product used for unknown indication |
| 126460391 | 12646039 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126460391 | 12646039 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126460391 | 12646039 | Arthralgia | |
| 126460391 | 12646039 | Bone disorder | |
| 126460391 | 12646039 | Dental implantation | |
| 126460391 | 12646039 | Dental prosthesis user | |
| 126460391 | 12646039 | Device failure | |
| 126460391 | 12646039 | Device related infection | |
| 126460391 | 12646039 | Drug ineffective | |
| 126460391 | 12646039 | Fatigue | |
| 126460391 | 12646039 | Headache | |
| 126460391 | 12646039 | Infection | |
| 126460391 | 12646039 | Insomnia | |
| 126460391 | 12646039 | Malaise | |
| 126460391 | 12646039 | Myalgia | |
| 126460391 | 12646039 | Nasopharyngitis | |
| 126460391 | 12646039 | Productive cough | |
| 126460391 | 12646039 | Sinus congestion | |
| 126460391 | 12646039 | Sinusitis |
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 |
|---|---|---|---|---|---|---|
| 126460391 | 12646039 | 5 | 2013 | 0 | ||
| 126460391 | 12646039 | 7 | 2013 | 0 |