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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113795719 | 11379571 | 9 | F | 20160712 | 20150814 | 20160718 | EXP | CA-AMGEN-CANSP2015081890 | AMGEN | 55.00 | YR | A | F | Y | 0.00000 | 20160718 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113795719 | 11379571 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 113795719 | 11379571 | 2 | SS | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | UNK | 0 | ||||||||||
| 113795719 | 11379571 | 3 | SS | ARTHROTEC | DICLOFENAC SODIUMMISOPROSTOL | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 113795719 | 11379571 | 4 | SS | CELEBREX | CELECOXIB | 1 | Unknown | UNK | 0 | CAPSULE | |||||||||
| 113795719 | 11379571 | 5 | SS | LYRICA | PREGABALIN | 1 | Unknown | UNK | 0 | CAPSULE | |||||||||
| 113795719 | 11379571 | 6 | I | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 113795719 | 11379571 | 7 | SS | NAPROSYN | NAPROXEN | 1 | Unknown | UNK | 0 | ||||||||||
| 113795719 | 11379571 | 8 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 113795719 | 11379571 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK | 0 | ||||||||||
| 113795719 | 11379571 | 10 | SS | VOLTAREN | DICLOFENAC SODIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 113795719 | 11379571 | 11 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 5 MG, BID | 0 | 5 | MG | BID | |||||||
| 113795719 | 11379571 | 12 | SS | NAPROXEN. | NAPROXEN | 1 | Unknown | UNK | 0 | ||||||||||
| 113795719 | 11379571 | 13 | SS | APO-AMITRIPTYLINE | AMITRIPTYLINE HYDROCHLORIDE | 1 | Unknown | UNK | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113795719 | 11379571 | 1 | Rheumatoid arthritis |
| 113795719 | 11379571 | 2 | Rheumatoid arthritis |
| 113795719 | 11379571 | 3 | Rheumatoid arthritis |
| 113795719 | 11379571 | 4 | Rheumatoid arthritis |
| 113795719 | 11379571 | 5 | Rheumatoid arthritis |
| 113795719 | 11379571 | 6 | Rheumatoid arthritis |
| 113795719 | 11379571 | 7 | Rheumatoid arthritis |
| 113795719 | 11379571 | 8 | Rheumatoid arthritis |
| 113795719 | 11379571 | 9 | Rheumatoid arthritis |
| 113795719 | 11379571 | 10 | Rheumatoid arthritis |
| 113795719 | 11379571 | 11 | Rheumatoid arthritis |
| 113795719 | 11379571 | 12 | Product used for unknown indication |
| 113795719 | 11379571 | 13 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113795719 | 11379571 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113795719 | 11379571 | Asthenia | |
| 113795719 | 11379571 | Condition aggravated | |
| 113795719 | 11379571 | Drug ineffective | |
| 113795719 | 11379571 | Drug interaction | |
| 113795719 | 11379571 | Gastrooesophageal reflux disease | |
| 113795719 | 11379571 | Impaired work ability | |
| 113795719 | 11379571 | Malaise | |
| 113795719 | 11379571 | Mobility decreased | |
| 113795719 | 11379571 | Muscle spasms | |
| 113795719 | 11379571 | Pain | |
| 113795719 | 11379571 | Pain in jaw | |
| 113795719 | 11379571 | Product quality issue | |
| 113795719 | 11379571 | Rheumatoid arthritis | |
| 113795719 | 11379571 | Swelling | |
| 113795719 | 11379571 | Wrist deformity |
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 |
|---|---|---|---|---|---|---|
| 113795719 | 11379571 | 1 | 2010 | 201507 | 0 | |
| 113795719 | 11379571 | 3 | 2004 | 2010 | 0 | |
| 113795719 | 11379571 | 6 | 2004 | 2015 | 0 | |
| 113795719 | 11379571 | 8 | 2004 | 2010 | 0 | |
| 113795719 | 11379571 | 10 | 2004 | 2010 | 0 | |
| 113795719 | 11379571 | 11 | 20150724 | 0 |