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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122994362 | 12299436 | 2 | F | 2009 | 20160711 | 20160425 | 20160719 | EXP | CA-JNJFOC-20160417949 | JANSSEN | 22.73 | YR | T | M | Y | 61.00000 | KG | 20160719 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122994362 | 12299436 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | THERAPY DURATION 52 | N | GBM13011 | 0 | 650 | MG | LYOPHILIZED POWDER | |||||
| 122994362 | 12299436 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13011 | 0 | 650 | MG | LYOPHILIZED POWDER | ||||||
| 122994362 | 12299436 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13011 | 0 | 325 | MG | LYOPHILIZED POWDER | ||||||
| 122994362 | 12299436 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | THERAPY DURATION 52 | N | GBM13011 | 0 | 650 | MG | LYOPHILIZED POWDER | |||||
| 122994362 | 12299436 | 5 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13011 | 103772 | 325 | MG | LYOPHILIZED POWDER | ||||||
| 122994362 | 12299436 | 6 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Unknown | 0 | 250 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122994362 | 12299436 | 1 | Colitis ulcerative |
| 122994362 | 12299436 | 2 | Colitis ulcerative |
| 122994362 | 12299436 | 3 | Colitis ulcerative |
| 122994362 | 12299436 | 4 | Colitis ulcerative |
| 122994362 | 12299436 | 5 | Colitis ulcerative |
| 122994362 | 12299436 | 6 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122994362 | 12299436 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122994362 | 12299436 | Frequent bowel movements | |
| 122994362 | 12299436 | General physical health deterioration | |
| 122994362 | 12299436 | Haematochezia | |
| 122994362 | 12299436 | Off label use | |
| 122994362 | 12299436 | Product use issue | |
| 122994362 | 12299436 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 122994362 | 12299436 | 2 | 20160711 | 0 | ||
| 122994362 | 12299436 | 3 | 20100506 | 0 | ||
| 122994362 | 12299436 | 4 | 20160418 | 0 | ||
| 122994362 | 12299436 | 5 | 2009 | 0 |