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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125223051 | 12522305 | 1 | I | 20150305 | 20160701 | 20160701 | EXP | FR-JNJFOC-20150305571 | JANSSEN | WILS P, BOUHNIK Y, FLOURIE B, BRIXI H, COSNES J, ALLEZ M, ET AL. USTEKINUMAB EFFICACY AND SAFETY IN CROHN^S DISEASE PATIENTS REFRACTORY TO CONVENTIONAL AND ANTI-TNF THERAPY: A MULTICENTER RETROSPECTIVE EXPERIENCE . JOURNAL OF CROHN^S AND COLITIS 2015:S18-S76. WILS P, BOUHNIK Y, FLOURIE B, BRIXI H, COSNES J, ALLEZ M, ET AL. USTEKINUMAB EFFICACY AND SAFETY IN CROHN^S PATIENTS REFRACTORY TO CONVENTIONAL AND ANTI-TNF THERAPY: A MULTICENTER RETROSPECTIVE EXPERIENCE. EUROPEAN CROHN^S AND COLITIS ORGA | 0.00 | Y | 0.00000 | 20160701 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125223051 | 12522305 | 1 | SS | USTEKINUMAB | USTEKINUMAB | 1 | Subcutaneous | U | U | 0 | SOLUTION FOR INJECTION | ||||||||
| 125223051 | 12522305 | 2 | PS | USTEKINUMAB | USTEKINUMAB | 1 | Subcutaneous | U | U | 125261 | SOLUTION FOR INJECTION | ||||||||
| 125223051 | 12522305 | 3 | SS | INFLIXIMAB | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | UNKNOWN | 103772 | LYOPHILIZED POWDER | |||||||
| 125223051 | 12522305 | 4 | SS | ADALIMUMAB | ADALIMUMAB | 1 | Unknown | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125223051 | 12522305 | 1 | Anorectal disorder |
| 125223051 | 12522305 | 2 | Crohn's disease |
| 125223051 | 12522305 | 3 | Crohn's disease |
| 125223051 | 12522305 | 4 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125223051 | 12522305 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125223051 | 12522305 | Adverse event | |
| 125223051 | 12522305 | Off label use | |
| 125223051 | 12522305 | Product use issue | |
| 125223051 | 12522305 | Treatment failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |