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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94783014 | 9478301 | 4 | F | 2011 | 20160905 | 20130827 | 20160909 | EXP | BR-JNJFOC-20130810937 | JANSSEN | 55.87 | YR | A | F | Y | 67.00000 | KG | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94783014 | 9478301 | 1 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | Y | UNKNOWN | 103772 | 300 | MG | LYOPHILIZED POWDER | |||||
| 94783014 | 9478301 | 2 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 94783014 | 9478301 | 3 | C | RENAPRIL | 2 | Unknown | 0 | UNSPECIFIED | |||||||||||
| 94783014 | 9478301 | 4 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 94783014 | 9478301 | 5 | C | TECNOMET | METHOTREXATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 94783014 | 9478301 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 94783014 | 9478301 | 7 | C | CAPTOPRIL. | CAPTOPRIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 94783014 | 9478301 | 8 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 94783014 | 9478301 | 9 | C | FLUNARIZINE DIHYDROCHLORIDE | FLUNARIZINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 94783014 | 9478301 | 10 | C | SIMVASTATINE | SIMVASTATIN | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 94783014 | 9478301 | 1 | Rheumatoid arthritis |
| 94783014 | 9478301 | 5 | Rheumatoid arthritis |
| 94783014 | 9478301 | 9 | Dizziness |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 94783014 | 9478301 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 94783014 | 9478301 | Anaemia | |
| 94783014 | 9478301 | Asthenia | |
| 94783014 | 9478301 | Blood cholesterol increased | |
| 94783014 | 9478301 | Dizziness | |
| 94783014 | 9478301 | Drug ineffective | |
| 94783014 | 9478301 | Hand deformity | |
| 94783014 | 9478301 | Heart rate decreased | |
| 94783014 | 9478301 | Inflammation | |
| 94783014 | 9478301 | Influenza | Influenza |
| 94783014 | 9478301 | Oropharyngeal pain | |
| 94783014 | 9478301 | Pain | |
| 94783014 | 9478301 | Pain in extremity | |
| 94783014 | 9478301 | Spinal pain | |
| 94783014 | 9478301 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 94783014 | 9478301 | 1 | 201005 | 201504 | 0 |