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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120838667 | 12083866 | 7 | F | 20150824 | 20160920 | 20160217 | 20160923 | EXP | BR-JNJFOC-20160212313 | JANSSEN | 15.74 | YR | T | M | Y | 35.00000 | KG | 20160923 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120838667 | 12083866 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;UNKNOWN | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 120838667 | 12083866 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;UNKNOWN | 0 | 2 | DF | LYOPHILIZED POWDER | ||||||
| 120838667 | 12083866 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;UNKNOWN | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 120838667 | 12083866 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;UNKNOWN | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 120838667 | 12083866 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;UNKNOWN | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 120838667 | 12083866 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;UNKNOWN | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 120838667 | 12083866 | 7 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;UNKNOWN | 0 | LYOPHILIZED POWDER | ||||||||
| 120838667 | 12083866 | 8 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;UNKNOWN | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 120838667 | 12083866 | 9 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 3RD INFUSION | N | UNKNOWN;UNKNOWN | 103772 | LYOPHILIZED POWDER | |||||||
| 120838667 | 12083866 | 10 | C | NUTRICAL D | 2 | Unknown | D | 0 | UNSPECIFIED | ||||||||||
| 120838667 | 12083866 | 11 | C | DEPURA | CHOLECALCIFEROL | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 120838667 | 12083866 | 12 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 120838667 | 12083866 | 13 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 120838667 | 12083866 | 14 | C | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 120838667 | 12083866 | 15 | C | RISEDRONATE SODIUM. | RISEDRONATE SODIUM | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 120838667 | 12083866 | 16 | C | MAXXI D3 | 2 | Unknown | D | 0 | UNSPECIFIED | ||||||||||
| 120838667 | 12083866 | 17 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | D | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120838667 | 12083866 | 1 | Crohn's disease |
| 120838667 | 12083866 | 2 | Crohn's disease |
| 120838667 | 12083866 | 3 | Crohn's disease |
| 120838667 | 12083866 | 4 | Crohn's disease |
| 120838667 | 12083866 | 5 | Crohn's disease |
| 120838667 | 12083866 | 6 | Crohn's disease |
| 120838667 | 12083866 | 7 | Crohn's disease |
| 120838667 | 12083866 | 8 | Crohn's disease |
| 120838667 | 12083866 | 9 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120838667 | 12083866 | HO |
| 120838667 | 12083866 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120838667 | 12083866 | Crohn's disease | |
| 120838667 | 12083866 | Depression | |
| 120838667 | 12083866 | Drug ineffective | |
| 120838667 | 12083866 | Gastrointestinal disorder | |
| 120838667 | 12083866 | Influenza | |
| 120838667 | 12083866 | Intestinal resection | |
| 120838667 | 12083866 | Malnutrition | |
| 120838667 | 12083866 | Off label use | |
| 120838667 | 12083866 | Osteoporosis | |
| 120838667 | 12083866 | Product use issue | |
| 120838667 | 12083866 | Pyrexia | |
| 120838667 | 12083866 | Vomiting | |
| 120838667 | 12083866 | 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 |
|---|---|---|---|---|---|---|
| 120838667 | 12083866 | 1 | 201603 | 0 | ||
| 120838667 | 12083866 | 2 | 20150824 | 0 | ||
| 120838667 | 12083866 | 3 | 20160730 | 0 | ||
| 120838667 | 12083866 | 4 | 20160220 | 0 | ||
| 120838667 | 12083866 | 5 | 20160506 | 0 | ||
| 120838667 | 12083866 | 6 | 20160212 | 0 | ||
| 120838667 | 12083866 | 7 | 20151223 | 0 | ||
| 120838667 | 12083866 | 8 | 201608 | 0 | ||
| 120838667 | 12083866 | 9 | 2015 | 0 | ||
| 120838667 | 12083866 | 12 | 201512 | 0 |