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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122572194 | 12257219 | 4 | F | 20160308 | 20160714 | 20160412 | 20160722 | EXP | CA-JNJFOC-20160406450 | JANSSEN | 15.08 | YR | T | F | Y | 51.90000 | KG | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122572194 | 12257219 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 122572194 | 12257219 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 122572194 | 12257219 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 122572194 | 12257219 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 122572194 | 12257219 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 122572194 | 12257219 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 122572194 | 12257219 | 7 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 122572194 | 12257219 | 8 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 122572194 | 12257219 | 9 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 122572194 | 12257219 | 10 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08011 | 103772 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 122572194 | 12257219 | 11 | C | IMURAN | AZATHIOPRINE | 1 | Oral | 0 | 100 | G | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122572194 | 12257219 | 1 | Crohn's disease |
| 122572194 | 12257219 | 2 | Crohn's disease |
| 122572194 | 12257219 | 3 | Crohn's disease |
| 122572194 | 12257219 | 4 | Crohn's disease |
| 122572194 | 12257219 | 5 | Crohn's disease |
| 122572194 | 12257219 | 6 | Colitis ulcerative |
| 122572194 | 12257219 | 7 | Colitis ulcerative |
| 122572194 | 12257219 | 8 | Colitis ulcerative |
| 122572194 | 12257219 | 9 | Colitis ulcerative |
| 122572194 | 12257219 | 10 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122572194 | 12257219 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122572194 | 12257219 | Diarrhoea | |
| 122572194 | 12257219 | General physical health deterioration | |
| 122572194 | 12257219 | Haematochezia | |
| 122572194 | 12257219 | Inappropriate schedule of drug administration | |
| 122572194 | 12257219 | Off label use | |
| 122572194 | 12257219 | 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 |
|---|---|---|---|---|---|---|
| 122572194 | 12257219 | 1 | 20160714 | 0 | ||
| 122572194 | 12257219 | 2 | 20160504 | 0 | ||
| 122572194 | 12257219 | 3 | 20160406 | 0 | ||
| 122572194 | 12257219 | 4 | 20160308 | 0 | ||
| 122572194 | 12257219 | 5 | 20160126 | 0 | ||
| 122572194 | 12257219 | 6 | 20160714 | 0 | ||
| 122572194 | 12257219 | 7 | 20160406 | 0 | ||
| 122572194 | 12257219 | 8 | 20160308 | 0 | ||
| 122572194 | 12257219 | 9 | 20160126 | 0 | ||
| 122572194 | 12257219 | 10 | 20160504 | 0 |