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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125761762 | 12576176 | 2 | F | 20160623 | 20160719 | 20160720 | 20160725 | EXP | US-JNJFOC-20160712246 | JANSSEN | 13.17 | YR | C | M | Y | 45.20000 | KG | 20160725 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125761762 | 12576176 | 1 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 103772 | LYOPHILIZED POWDER | |||||||||
| 125761762 | 12576176 | 2 | C | 5-ASA | MESALAMINE | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 125761762 | 12576176 | 3 | C | BUDESONIDE. | BUDESONIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125761762 | 12576176 | 4 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125761762 | 12576176 | 1 | Colitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125761762 | 12576176 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125761762 | 12576176 | Colitis |
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 |
|---|---|---|---|---|---|---|
| 125761762 | 12576176 | 1 | 20141117 | 0 |