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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123602053 | 12360205 | 3 | F | 2010 | 20160726 | 20160512 | 20160802 | EXP | US-JNJFOC-20160504860 | JANSSEN | 0.00 | A | F | Y | 72.12000 | KG | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123602053 | 12360205 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 0 | LYOPHILIZED POWDER | |||||||
| 123602053 | 12360205 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 0 | LYOPHILIZED POWDER | |||||||
| 123602053 | 12360205 | 3 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | ABOUT 12 TO 13 YEARS PRIOR TO THIS REPORT (2003 OR 2004). | Y | N | UNKNOWN | 103772 | LYOPHILIZED POWDER | ||||||
| 123602053 | 12360205 | 4 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123602053 | 12360205 | 1 | Psoriatic arthropathy |
| 123602053 | 12360205 | 2 | Psoriatic arthropathy |
| 123602053 | 12360205 | 3 | Psoriatic arthropathy |
| 123602053 | 12360205 | 4 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123602053 | 12360205 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123602053 | 12360205 | Drug effect decreased | |
| 123602053 | 12360205 | Erythema | |
| 123602053 | 12360205 | Fibromyalgia | |
| 123602053 | 12360205 | Flushing | |
| 123602053 | 12360205 | Lip swelling | |
| 123602053 | 12360205 | Off label use | |
| 123602053 | 12360205 | Product use issue | |
| 123602053 | 12360205 | Systemic lupus erythematosus | |
| 123602053 | 12360205 | Transient ischaemic attack |
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 |
|---|---|---|---|---|---|---|
| 123602053 | 12360205 | 1 | 201103 | 0 | ||
| 123602053 | 12360205 | 2 | 201012 | 0 |