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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117912292 | 11791229 | 2 | F | 20150121 | 20160816 | 20151201 | 20160824 | EXP | BR-JNJFOC-20150201616 | JANSSEN | 51.08 | YR | A | F | Y | 83.00000 | KG | 20160824 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117912292 | 11791229 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 117912292 | 11791229 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | LYOPHILIZED POWDER | ||||||||
| 117912292 | 11791229 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 117912292 | 11791229 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 103772 | LYOPHILIZED POWDER | ||||||||
| 117912292 | 11791229 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 117912292 | 11791229 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | Y | 0 | 20 | MG | UNSPECIFIED | |||||||
| 117912292 | 11791229 | 7 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 117912292 | 11791229 | 8 | C | ARAVA | LEFLUNOMIDE | 1 | Unknown | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 117912292 | 11791229 | 9 | C | OLMETEC | OLMESARTAN MEDOXOMIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 117912292 | 11791229 | 10 | C | FLUXENE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 117912292 | 11791229 | 11 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 117912292 | 11791229 | 12 | C | BROMAZEPAM | BROMAZEPAM | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117912292 | 11791229 | 1 | Rheumatoid arthritis |
| 117912292 | 11791229 | 2 | Rheumatoid arthritis |
| 117912292 | 11791229 | 3 | Ankylosing spondylitis |
| 117912292 | 11791229 | 4 | Ankylosing spondylitis |
| 117912292 | 11791229 | 5 | Product used for unknown indication |
| 117912292 | 11791229 | 6 | Product used for unknown indication |
| 117912292 | 11791229 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117912292 | 11791229 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117912292 | 11791229 | Chest pain | |
| 117912292 | 11791229 | Eye irritation | |
| 117912292 | 11791229 | Feeling hot | |
| 117912292 | 11791229 | Gastritis | |
| 117912292 | 11791229 | Headache | |
| 117912292 | 11791229 | Hypertension | |
| 117912292 | 11791229 | Infusion related reaction | |
| 117912292 | 11791229 | Keratitis | |
| 117912292 | 11791229 | Lactose intolerance | |
| 117912292 | 11791229 | Malaise | |
| 117912292 | 11791229 | Migraine | |
| 117912292 | 11791229 | Myalgia | |
| 117912292 | 11791229 | Pain | |
| 117912292 | 11791229 | Pharyngitis | |
| 117912292 | 11791229 | Polyp | |
| 117912292 | 11791229 | Thyroid cyst | |
| 117912292 | 11791229 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 117912292 | 11791229 | 1 | 20150120 | 0 | ||
| 117912292 | 11791229 | 2 | 201509 | 0 | ||
| 117912292 | 11791229 | 3 | 20150120 | 0 | ||
| 117912292 | 11791229 | 4 | 201509 | 0 |