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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124488183 | 12448818 | 3 | F | 20160806 | 20160608 | 20160813 | EXP | US-JNJFOC-20160601540 | JANSSEN | SHAPIRO JM, SUBEDI S, MACHAN JT, CEREZO CS, ROSS AM, SHALON LB, ET AL. DURABILITY OF INFLIXIMAB IS ASSOCIATED WITH DISEASE EXTENT IN CHILDREN WITH INFLAMMATORY BOWEL DISEASE. JOURNAL OF PEDIATRIC GASTROENTEROLOGY AND NUTRITION 2016;62(6):867-72. | 0.00 | Y | 0.00000 | 20160812 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124488183 | 12448818 | 1 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 103772 | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124488183 | 12448818 | 1 | Inflammatory bowel disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124488183 | 12448818 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124488183 | 12448818 | Colectomy | |
| 124488183 | 12448818 | Drug ineffective |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |