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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86716196 | 8671619 | 6 | F | 20110614 | 20160819 | 20120718 | 20160824 | EXP | IT-JNJFOC-20120707035 | JANSSEN | 0.00 | A | F | Y | 51.00000 | KG | 20160824 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86716196 | 8671619 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | DOSE: 255 MG | N | 0 | 5 | MG/KG | LYOPHILIZED POWDER | ||||||
| 86716196 | 8671619 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | STOPPED AFTER SECOND INFUSION DUE TO AN INFUSION RELATED REACTION | N | 103772 | 5 | MG/KG | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 86716196 | 8671619 | 1 | Colitis ulcerative |
| 86716196 | 8671619 | 2 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 86716196 | 8671619 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 86716196 | 8671619 | Abdominal pain | |
| 86716196 | 8671619 | Diarrhoea | |
| 86716196 | 8671619 | Ileostomy closure | |
| 86716196 | 8671619 | Pyrexia | |
| 86716196 | 8671619 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 86716196 | 8671619 | 1 | 200807 | 0 | ||
| 86716196 | 8671619 | 2 | 200807 | 0 |