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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125619891 | 12561989 | 1 | I | 2016 | 20160510 | 20160715 | 20160715 | EXP | CA-JNJFOC-20160511693 | JANSSEN | 32.40 | YR | A | M | Y | 82.00000 | KG | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125619891 | 12561989 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | ALSO REPORTED AS 820 MG | N | FJM80011 | 0 | 10 | MG/KG | LYOPHILIZED POWDER | |||||
| 125619891 | 12561989 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | INDUCTION | N | FJM80011 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 125619891 | 12561989 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | INDUCTION | N | FJM80011 | 0 | 820 | MG | LYOPHILIZED POWDER | |||||
| 125619891 | 12561989 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | INDUCTION | N | FJM80011 | 103772 | 820 | MG | LYOPHILIZED POWDER | |||||
| 125619891 | 12561989 | 5 | SS | IMURAN | AZATHIOPRINE | 1 | Unknown | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125619891 | 12561989 | 1 | Colitis ulcerative |
| 125619891 | 12561989 | 2 | Colitis ulcerative |
| 125619891 | 12561989 | 3 | Colitis ulcerative |
| 125619891 | 12561989 | 4 | Colitis ulcerative |
| 125619891 | 12561989 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125619891 | 12561989 | OT |
| 125619891 | 12561989 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125619891 | 12561989 | Colitis ulcerative | |
| 125619891 | 12561989 | General physical health deterioration | |
| 125619891 | 12561989 | Nausea | |
| 125619891 | 12561989 | Therapeutic response decreased | |
| 125619891 | 12561989 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125619891 | 12561989 | 1 | 20160215 | 0 | ||
| 125619891 | 12561989 | 3 | 20160510 | 0 | ||
| 125619891 | 12561989 | 4 | 20160704 | 0 | ||
| 125619891 | 12561989 | 5 | 20160629 | 0 |