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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119709913 | 11970991 | 3 | F | 20160125 | 20160920 | 20160128 | 20160926 | EXP | CA-JNJFOC-20160119561 | JANSSEN | 42.82 | YR | A | F | Y | 94.00000 | KG | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119709913 | 11970991 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | U | GBM13012 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 119709913 | 11970991 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | # 57 INFUSION UNTIL NOW | N | U | GBM13012 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||
| 119709913 | 11970991 | 3 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | U | GBM13012 | 103772 | 400 | MG | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119709913 | 11970991 | 1 | Crohn's disease |
| 119709913 | 11970991 | 2 | Crohn's disease |
| 119709913 | 11970991 | 3 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119709913 | 11970991 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119709913 | 11970991 | Abdominal pain | |
| 119709913 | 11970991 | Frequent bowel movements | |
| 119709913 | 11970991 | General physical health deterioration | |
| 119709913 | 11970991 | Paranasal sinus neoplasm | |
| 119709913 | 11970991 | Surgery |
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 |
|---|---|---|---|---|---|---|
| 119709913 | 11970991 | 1 | 20160920 | 0 | ||
| 119709913 | 11970991 | 2 | 20080409 | 20151204 | 0 | |
| 119709913 | 11970991 | 3 | 20160727 | 0 |