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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123565096 | 12356509 | 6 | F | 201604 | 20160824 | 20160511 | 20160830 | EXP | CA-JNJFOC-20160413871 | JANSSEN | 30.16 | YR | A | F | Y | 73.50000 | KG | 20160830 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123565096 | 12356509 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 350 | MG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 350 | MG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 10 | MG/KG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 7 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 8 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 9 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 10 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 11 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 10 | MG/KG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 12 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 350 | MG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 13 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 14 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 350 | MG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 15 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 16 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 17 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 18 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012;GBM13013;GCM23016 | 103772 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 123565096 | 12356509 | 19 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123565096 | 12356509 | 1 | Crohn's disease |
| 123565096 | 12356509 | 2 | Crohn's disease |
| 123565096 | 12356509 | 3 | Crohn's disease |
| 123565096 | 12356509 | 4 | Crohn's disease |
| 123565096 | 12356509 | 5 | Crohn's disease |
| 123565096 | 12356509 | 6 | Crohn's disease |
| 123565096 | 12356509 | 7 | Crohn's disease |
| 123565096 | 12356509 | 8 | Crohn's disease |
| 123565096 | 12356509 | 9 | Crohn's disease |
| 123565096 | 12356509 | 10 | Colitis ulcerative |
| 123565096 | 12356509 | 11 | Colitis ulcerative |
| 123565096 | 12356509 | 12 | Colitis ulcerative |
| 123565096 | 12356509 | 13 | Colitis ulcerative |
| 123565096 | 12356509 | 14 | Colitis ulcerative |
| 123565096 | 12356509 | 15 | Colitis ulcerative |
| 123565096 | 12356509 | 16 | Colitis ulcerative |
| 123565096 | 12356509 | 17 | Colitis ulcerative |
| 123565096 | 12356509 | 18 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123565096 | 12356509 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123565096 | 12356509 | Drug ineffective | |
| 123565096 | 12356509 | Exposure during pregnancy | |
| 123565096 | 12356509 | Frequent bowel movements | |
| 123565096 | 12356509 | General physical health deterioration | |
| 123565096 | 12356509 | Haematochezia | |
| 123565096 | 12356509 | Hypophagia | |
| 123565096 | 12356509 | Malaise | |
| 123565096 | 12356509 | Off label use | |
| 123565096 | 12356509 | Product use issue | |
| 123565096 | 12356509 | Transfusion |
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 |
|---|---|---|---|---|---|---|
| 123565096 | 12356509 | 2 | 20160425 | 0 | ||
| 123565096 | 12356509 | 3 | 20160503 | 0 | ||
| 123565096 | 12356509 | 4 | 20160412 | 0 | ||
| 123565096 | 12356509 | 5 | 20160412 | 0 | ||
| 123565096 | 12356509 | 6 | 20160824 | 0 | ||
| 123565096 | 12356509 | 7 | 20160728 | 0 | ||
| 123565096 | 12356509 | 8 | 20160623 | 0 | ||
| 123565096 | 12356509 | 9 | 20160526 | 0 | ||
| 123565096 | 12356509 | 11 | 20160412 | 0 | ||
| 123565096 | 12356509 | 12 | 20160425 | 0 | ||
| 123565096 | 12356509 | 13 | 20160412 | 0 | ||
| 123565096 | 12356509 | 14 | 20160503 | 0 | ||
| 123565096 | 12356509 | 15 | 20160824 | 0 | ||
| 123565096 | 12356509 | 16 | 20160728 | 0 | ||
| 123565096 | 12356509 | 17 | 20160623 | 0 | ||
| 123565096 | 12356509 | 18 | 20160526 | 0 |