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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103605523 | 10360552 | 3 | F | 201310 | 20160627 | 20140804 | 20160705 | EXP | CA-ABBVIE-14K-028-1266319-00 | ABBVIE | 51.77 | YR | M | Y | 79.45000 | KG | 20160705 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103605523 | 10360552 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||||
| 103605523 | 10360552 | 2 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 103605523 | 10360552 | 1 | Crohn's disease |
| 103605523 | 10360552 | 2 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 103605523 | 10360552 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 103605523 | 10360552 | Abdominal pain | |
| 103605523 | 10360552 | Gastrointestinal infection | |
| 103605523 | 10360552 | Intestinal fistula | |
| 103605523 | 10360552 | Intestinal mass | |
| 103605523 | 10360552 | Large intestine perforation | |
| 103605523 | 10360552 | Post procedural discharge |
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 |
|---|---|---|---|---|---|---|
| 103605523 | 10360552 | 1 | 20100615 | 0 |