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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116088122 | 11608812 | 2 | F | 2013 | 20160712 | 20151007 | 20160719 | EXP | BR-JNJFOC-20151001260 | JANSSEN | 0.00 | A | F | Y | 167.00000 | KG | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116088122 | 11608812 | 1 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | UNKNOWN | 103772 | 300 | MG | LYOPHILIZED POWDER | |||||
| 116088122 | 11608812 | 2 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | 0 | 150 | MG | TABLET | ||||||||
| 116088122 | 11608812 | 3 | C | MESALAZINE | MESALAMINE | 1 | Unknown | 0 | 800 | MG | UNSPECIFIED | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116088122 | 11608812 | 1 | Crohn's disease |
| 116088122 | 11608812 | 2 | Crohn's disease |
| 116088122 | 11608812 | 3 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116088122 | 11608812 | OT |
| 116088122 | 11608812 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116088122 | 11608812 | Crohn's disease | |
| 116088122 | 11608812 | Hypotension | |
| 116088122 | 11608812 | Hypothermia | |
| 116088122 | 11608812 | Immunosuppression | |
| 116088122 | 11608812 | Nasopharyngitis | |
| 116088122 | 11608812 | Nausea | |
| 116088122 | 11608812 | Off label use | |
| 116088122 | 11608812 | Sepsis | |
| 116088122 | 11608812 | Vein disorder | |
| 116088122 | 11608812 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 116088122 | 11608812 | 1 | 20120104 | 201512 | 0 | |
| 116088122 | 11608812 | 2 | 2010 | 0 | ||
| 116088122 | 11608812 | 3 | 2010 | 0 |