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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110877064 | 11087706 | 4 | F | 201502 | 20160824 | 20150504 | 20160826 | EXP | BR-JNJFOC-20150422929 | JANSSEN | 54.83 | YR | A | M | Y | 63.00000 | KG | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110877064 | 11087706 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 110877064 | 11087706 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 110877064 | 11087706 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 110877064 | 11087706 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 110877064 | 11087706 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 110877064 | 11087706 | 6 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | UNKNOWN | 103772 | 400 | MG | LYOPHILIZED POWDER | |||||
| 110877064 | 11087706 | 7 | SS | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | N | 0 | 100 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110877064 | 11087706 | 1 | Colitis ulcerative |
| 110877064 | 11087706 | 2 | Colitis ulcerative |
| 110877064 | 11087706 | 3 | Colitis ulcerative |
| 110877064 | 11087706 | 4 | Colitis |
| 110877064 | 11087706 | 5 | Colitis |
| 110877064 | 11087706 | 6 | Colitis |
| 110877064 | 11087706 | 7 | Colitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110877064 | 11087706 | OT |
| 110877064 | 11087706 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110877064 | 11087706 | Drug ineffective | |
| 110877064 | 11087706 | Frequent bowel movements | |
| 110877064 | 11087706 | Off label use | |
| 110877064 | 11087706 | Product use issue | |
| 110877064 | 11087706 | Pulmonary tuberculosis |
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 |
|---|---|---|---|---|---|---|
| 110877064 | 11087706 | 1 | 20160815 | 0 | ||
| 110877064 | 11087706 | 2 | 20160620 | 0 | ||
| 110877064 | 11087706 | 3 | 20120331 | 20150421 | 0 | |
| 110877064 | 11087706 | 4 | 20160815 | 0 | ||
| 110877064 | 11087706 | 5 | 20120331 | 20150421 | 0 | |
| 110877064 | 11087706 | 6 | 20160620 | 0 | ||
| 110877064 | 11087706 | 7 | 20130718 | 20150421 | 0 |