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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124527864 | 12452786 | 4 | F | 2013 | 20160704 | 20160609 | 20160712 | EXP | BR-JNJFOC-20160520067 | JANSSEN | 0.00 | A | F | Y | 65.00000 | KG | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124527864 | 12452786 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 0, 2 AND 6 WEEKS FREQUENCY | Y | U | UNKNOWN | 0 | 300 | MG | LYOPHILIZED POWDER | ||||
| 124527864 | 12452786 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 0, 2 AND 6 WEEKS FREQUENCY | Y | U | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | ||||
| 124527864 | 12452786 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 124527864 | 12452786 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN | 0 | LYOPHILIZED POWDER | |||||||
| 124527864 | 12452786 | 5 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 0, 2 AND 6 WEEKS FREQUENCY | Y | U | UNKNOWN | 103772 | 300 | MG | LYOPHILIZED POWDER | ||||
| 124527864 | 12452786 | 6 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124527864 | 12452786 | 7 | C | MESALAZINE | MESALAMINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124527864 | 12452786 | 8 | C | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124527864 | 12452786 | 9 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124527864 | 12452786 | 10 | C | ISONIAZID. | ISONIAZID | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124527864 | 12452786 | 1 | Crohn's disease |
| 124527864 | 12452786 | 2 | Crohn's disease |
| 124527864 | 12452786 | 3 | Crohn's disease |
| 124527864 | 12452786 | 4 | Crohn's disease |
| 124527864 | 12452786 | 5 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124527864 | 12452786 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124527864 | 12452786 | Abdominal distension | |
| 124527864 | 12452786 | Cytomegalovirus infection | |
| 124527864 | 12452786 | Diarrhoea | |
| 124527864 | 12452786 | Drug prescribing error | |
| 124527864 | 12452786 | Endometriosis | |
| 124527864 | 12452786 | Fistula | |
| 124527864 | 12452786 | Gastrointestinal stenosis | |
| 124527864 | 12452786 | Headache | |
| 124527864 | 12452786 | Malaise | |
| 124527864 | 12452786 | Off label use | |
| 124527864 | 12452786 | Pain | |
| 124527864 | 12452786 | Skin bacterial infection |
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 |
|---|---|---|---|---|---|---|
| 124527864 | 12452786 | 3 | 20130101 | 20150630 | 0 | |
| 124527864 | 12452786 | 4 | 2014 | 0 | ||
| 124527864 | 12452786 | 5 | 2012 | 0 |