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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122994376 | 12299437 | 6 | F | 20160127 | 20160910 | 20160425 | 20160916 | EXP | CA-JNJFOC-20160418688 | JANSSEN | 15.86 | YR | T | M | Y | 84.37000 | KG | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122994376 | 12299437 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13011;GAM14013;GDM31014 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 122994376 | 12299437 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13011;GAM14013;GDM31014 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 122994376 | 12299437 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13011;GAM14013;GDM31014 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 122994376 | 12299437 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13011;GAM14013;GDM31014 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 122994376 | 12299437 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13011;GAM14013;GDM31014 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 122994376 | 12299437 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13011;GAM14013;GDM31014 | 0 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 122994376 | 12299437 | 7 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13011;GAM14013;GDM31014 | 103772 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 122994376 | 12299437 | 8 | C | MEZAVANT | MESALAMINE | 1 | Unknown | D | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122994376 | 12299437 | 1 | Colitis ulcerative |
| 122994376 | 12299437 | 2 | Colitis ulcerative |
| 122994376 | 12299437 | 3 | Colitis ulcerative |
| 122994376 | 12299437 | 4 | Colitis ulcerative |
| 122994376 | 12299437 | 5 | Colitis ulcerative |
| 122994376 | 12299437 | 6 | Colitis ulcerative |
| 122994376 | 12299437 | 7 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122994376 | 12299437 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122994376 | 12299437 | Body temperature increased | |
| 122994376 | 12299437 | Colitis ulcerative | |
| 122994376 | 12299437 | General physical health deterioration | |
| 122994376 | 12299437 | Off label use | |
| 122994376 | 12299437 | 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 |
|---|---|---|---|---|---|---|
| 122994376 | 12299437 | 1 | 20160910 | 0 | ||
| 122994376 | 12299437 | 2 | 20160127 | 0 | ||
| 122994376 | 12299437 | 3 | 20160419 | 0 | ||
| 122994376 | 12299437 | 4 | 20160615 | 0 | ||
| 122994376 | 12299437 | 5 | 20160712 | 0 | ||
| 122994376 | 12299437 | 6 | 20160817 | 0 | ||
| 122994376 | 12299437 | 7 | 201603 | 0 |