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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100569095 | 10056909 | 5 | F | 201309 | 20160915 | 20140403 | 20160923 | EXP | CA-JNJFOC-20131113313 | JANSSEN | 26.93 | YR | A | F | Y | 89.81000 | KG | 20160923 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100569095 | 10056909 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | DDM31012;GDM3104 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 100569095 | 10056909 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | DDM31012;GDM3104 | 0 | LYOPHILIZED POWDER | ||||||||
| 100569095 | 10056909 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | DDM31012;GDM3104 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 100569095 | 10056909 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | DDM31012;GDM3104 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 100569095 | 10056909 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | DDM31012;GDM3104 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 100569095 | 10056909 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | DDM31012;GDM3104 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 100569095 | 10056909 | 7 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | DDM31012;GDM3104 | 103772 | 600 | MG | LYOPHILIZED POWDER | ||||||
| 100569095 | 10056909 | 8 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Unknown | D | 0 | 40 | MG | UNSPECIFIED | QD | ||||||
| 100569095 | 10056909 | 9 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Unknown | D | 0 | 20 | MG | UNSPECIFIED | BID | ||||||
| 100569095 | 10056909 | 10 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | D | 0 | 15 | MG | UNSPECIFIED | |||||||
| 100569095 | 10056909 | 11 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Unknown | D | 0 | 150 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 100569095 | 10056909 | 1 | Crohn's disease |
| 100569095 | 10056909 | 2 | Crohn's disease |
| 100569095 | 10056909 | 3 | Crohn's disease |
| 100569095 | 10056909 | 4 | Crohn's disease |
| 100569095 | 10056909 | 5 | Crohn's disease |
| 100569095 | 10056909 | 6 | Crohn's disease |
| 100569095 | 10056909 | 7 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 100569095 | 10056909 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 100569095 | 10056909 | Crohn's disease | |
| 100569095 | 10056909 | Drug ineffective | |
| 100569095 | 10056909 | Faeces hard | |
| 100569095 | 10056909 | General physical health deterioration | |
| 100569095 | 10056909 | Intestinal obstruction | |
| 100569095 | 10056909 | Intestinal resection | |
| 100569095 | 10056909 | Off label use | |
| 100569095 | 10056909 | Pain | |
| 100569095 | 10056909 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 100569095 | 10056909 | 2 | 20130523 | 0 | ||
| 100569095 | 10056909 | 4 | 20160915 | 0 | ||
| 100569095 | 10056909 | 5 | 20130509 | 0 | ||
| 100569095 | 10056909 | 6 | 20130509 | 0 | ||
| 100569095 | 10056909 | 7 | 20140203 | 0 |