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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124765587 | 12476558 | 7 | F | 201510 | 20160831 | 20160617 | 20160907 | EXP | CA-JNJFOC-20160602853 | JANSSEN | 16.81 | YR | T | F | Y | 49.00000 | KG | 20160907 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124765587 | 12476558 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FKM95012;GAM0812;GAM14013;GCM23016 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 124765587 | 12476558 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FKM95012;GAM0812;GAM14013;GCM23016 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 124765587 | 12476558 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FKM95012;GAM0812;GAM14013;GCM23016 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 124765587 | 12476558 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FKM95012;GAM0812;GAM14013;GCM23016 | 0 | 5 | MG/KG | LYOPHILIZED POWDER | ||||||
| 124765587 | 12476558 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FKM95012;GAM0812;GAM14013;GCM23016 | 0 | 5 | MG/KG | LYOPHILIZED POWDER | ||||||
| 124765587 | 12476558 | 6 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FKM95012;GAM0812;GAM14013;GCM23016 | 103772 | 300 | MG | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124765587 | 12476558 | 1 | Colitis ulcerative |
| 124765587 | 12476558 | 2 | Colitis ulcerative |
| 124765587 | 12476558 | 3 | Colitis ulcerative |
| 124765587 | 12476558 | 4 | Colitis ulcerative |
| 124765587 | 12476558 | 5 | Colitis ulcerative |
| 124765587 | 12476558 | 6 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124765587 | 12476558 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124765587 | 12476558 | Clostridium difficile infection | |
| 124765587 | 12476558 | Colitis ulcerative | |
| 124765587 | 12476558 | Drug effect decreased | |
| 124765587 | 12476558 | General physical health deterioration | |
| 124765587 | 12476558 | Off label use | |
| 124765587 | 12476558 | 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 |
|---|---|---|---|---|---|---|
| 124765587 | 12476558 | 1 | 20160824 | 0 | ||
| 124765587 | 12476558 | 2 | 20160323 | 0 | ||
| 124765587 | 12476558 | 3 | 20160721 | 0 | ||
| 124765587 | 12476558 | 5 | 20160323 | 0 | ||
| 124765587 | 12476558 | 6 | 20160610 | 0 |