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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122147252 | 12214725 | 2 | F | 201512 | 20160706 | 20160328 | 20160712 | EXP | BR-JNJFOC-20160322056 | JANSSEN | 14.37 | YR | C | M | Y | 35.00000 | KG | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122147252 | 12214725 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | 5 | MG/KG | LYOPHILIZED POWDER | ||||||
| 122147252 | 12214725 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | 200 | MG | LYOPHILIZED POWDER | ||||||
| 122147252 | 12214725 | 3 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 103772 | 200 | MG | LYOPHILIZED POWDER | ||||||
| 122147252 | 12214725 | 4 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | 0 | 50 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122147252 | 12214725 | 1 | Crohn's disease |
| 122147252 | 12214725 | 2 | Crohn's disease |
| 122147252 | 12214725 | 3 | Crohn's disease |
| 122147252 | 12214725 | 4 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122147252 | 12214725 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122147252 | 12214725 | Dyspnoea | |
| 122147252 | 12214725 | Eye movement disorder | |
| 122147252 | 12214725 | Hyperhidrosis | |
| 122147252 | 12214725 | Hypotension | |
| 122147252 | 12214725 | Infusion related reaction | |
| 122147252 | 12214725 | Off label use | |
| 122147252 | 12214725 | Product use issue | |
| 122147252 | 12214725 | Tachycardia |
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 |
|---|---|---|---|---|---|---|
| 122147252 | 12214725 | 1 | 201506 | 0 | ||
| 122147252 | 12214725 | 2 | 201512 | 0 | ||
| 122147252 | 12214725 | 3 | 201601 | 0 |