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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112887407 | 11288740 | 7 | F | 2013 | 20160729 | 20150721 | 20160803 | EXP | CA-JNJFOC-20150711265 | JANSSEN | 33.34 | YR | A | M | Y | 75.00000 | KG | 20160803 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112887407 | 11288740 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 300 | MG | LYOPHILIZED POWDER | |||||||
| 112887407 | 11288740 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 400 | MG | LYOPHILIZED POWDER | |||||||
| 112887407 | 11288740 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 400 | MG | LYOPHILIZED POWDER | |||||||
| 112887407 | 11288740 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 400 | MG | LYOPHILIZED POWDER | |||||||
| 112887407 | 11288740 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 400 | MG | LYOPHILIZED POWDER | |||||||
| 112887407 | 11288740 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 400 | MG | LYOPHILIZED POWDER | |||||||
| 112887407 | 11288740 | 7 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 10 | MG/KG | LYOPHILIZED POWDER | |||||||
| 112887407 | 11288740 | 8 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 10 | MG/KG | LYOPHILIZED POWDER | |||||||
| 112887407 | 11288740 | 9 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 400 | MG | LYOPHILIZED POWDER | |||||||
| 112887407 | 11288740 | 10 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 400 | MG | LYOPHILIZED POWDER | |||||||
| 112887407 | 11288740 | 11 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 300 | MG | LYOPHILIZED POWDER | |||||||
| 112887407 | 11288740 | 12 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 400 | MG | LYOPHILIZED POWDER | |||||||
| 112887407 | 11288740 | 13 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 400 | MG | LYOPHILIZED POWDER | |||||||
| 112887407 | 11288740 | 14 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 103772 | 400 | MG | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112887407 | 11288740 | 1 | Colitis ulcerative |
| 112887407 | 11288740 | 2 | Colitis ulcerative |
| 112887407 | 11288740 | 3 | Colitis ulcerative |
| 112887407 | 11288740 | 4 | Colitis ulcerative |
| 112887407 | 11288740 | 5 | Colitis ulcerative |
| 112887407 | 11288740 | 6 | Colitis ulcerative |
| 112887407 | 11288740 | 7 | Colitis ulcerative |
| 112887407 | 11288740 | 8 | Crohn's disease |
| 112887407 | 11288740 | 9 | Crohn's disease |
| 112887407 | 11288740 | 10 | Crohn's disease |
| 112887407 | 11288740 | 11 | Crohn's disease |
| 112887407 | 11288740 | 12 | Crohn's disease |
| 112887407 | 11288740 | 13 | Crohn's disease |
| 112887407 | 11288740 | 14 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112887407 | 11288740 | HO |
| 112887407 | 11288740 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112887407 | 11288740 | Colitis ulcerative | |
| 112887407 | 11288740 | Gastric cancer | |
| 112887407 | 11288740 | Incision site pain | |
| 112887407 | 11288740 | Off label use | |
| 112887407 | 11288740 | Product use issue | |
| 112887407 | 11288740 | Retching | |
| 112887407 | 11288740 | Vomiting | |
| 112887407 | 11288740 | 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 |
|---|---|---|---|---|---|---|
| 112887407 | 11288740 | 2 | 201307 | 0 | ||
| 112887407 | 11288740 | 3 | 201306 | 0 | ||
| 112887407 | 11288740 | 4 | 20160317 | 0 | ||
| 112887407 | 11288740 | 9 | 201306 | 0 | ||
| 112887407 | 11288740 | 10 | 201307 | 0 | ||
| 112887407 | 11288740 | 14 | 20160317 | 0 |