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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126576631 | 12657663 | 1 | I | 20160809 | 20160816 | 20160816 | EXP | PL-JNJFOC-20160808058 | JANSSEN | IWANCZAK BM, RYZKO J, JANKOWSKI P, SLADEK M, WASILEWSKA A, SZCZEPANIK M, ET AL. INDUCTION AND MAINTENANCE INFLIXIMAB THERAPY FOR THE TREATMENT OF CROHN^S DISEASE WITH PERIANALFISTULAS IN CHILDREN: RETROSPECTIVE, MULTICENTER STUDY. ADVANCES IN CLINICAL AND EXPERIMENTAL MEDICINE 2016;25 (3):523-530. | 0.00 | Y | 0.00000 | 20160816 | OT | PL | PL |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126576631 | 12657663 | 1 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | UNKNOWN | 103772 | 5 | MG/KG | LYOPHILIZED POWDER |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126576631 | 12657663 | 1 | Crohn's disease |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126576631 | 12657663 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126576631 | 12657663 | Anal fistula | |
126576631 | 12657663 | Anaphylactic shock | |
126576631 | 12657663 | Drug ineffective |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |