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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113911692 | 11391169 | 2 | F | 2015 | 20160713 | 20150818 | 20160719 | EXP | BR-JNJFOC-20150810356 | JANSSEN | 0.00 | A | M | Y | 0.00000 | 20160719 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113911692 | 11391169 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | LYOPHILIZED POWDER | ||||||||
| 113911692 | 11391169 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | LYOPHILIZED POWDER | ||||||||
| 113911692 | 11391169 | 3 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | LAST INFUSION | U | UNKNOWN | 103772 | LYOPHILIZED POWDER | |||||||
| 113911692 | 11391169 | 4 | C | MESALAZINE | MESALAMINE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113911692 | 11391169 | 1 | Crohn's disease |
| 113911692 | 11391169 | 2 | Crohn's disease |
| 113911692 | 11391169 | 3 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113911692 | 11391169 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113911692 | 11391169 | Abdominal distension | |
| 113911692 | 11391169 | Asthenia | |
| 113911692 | 11391169 | Crohn's disease | |
| 113911692 | 11391169 | Diarrhoea | |
| 113911692 | 11391169 | Haemorrhage | |
| 113911692 | 11391169 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 113911692 | 11391169 | 2 | 20150622 | 0 | ||
| 113911692 | 11391169 | 3 | 20150707 | 0 |