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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112856544 | 11285654 | 4 | F | 20150604 | 20160629 | 20150721 | 20160712 | EXP | BR-ABBVIE-15K-020-1427480-00 | ABBVIE | 51.10 | YR | F | Y | 57.00000 | KG | 20160712 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112856544 | 11285654 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 47043XH02 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 112856544 | 11285654 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 47043XH02 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 112856544 | 11285654 | 3 | SS | MESALAZINE | MESALAMINE | 1 | Oral | UNKNOWN | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112856544 | 11285654 | 1 | Crohn's disease |
| 112856544 | 11285654 | 3 | Gastrointestinal disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112856544 | 11285654 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112856544 | 11285654 | Abdominal distension | |
| 112856544 | 11285654 | Abdominal pain | |
| 112856544 | 11285654 | Drug effect decreased | |
| 112856544 | 11285654 | Drug ineffective | |
| 112856544 | 11285654 | Gastrointestinal motility disorder | |
| 112856544 | 11285654 | Intestinal ulcer | |
| 112856544 | 11285654 | Pain in extremity | |
| 112856544 | 11285654 | Spinal pain |
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 |
|---|---|---|---|---|---|---|
| 112856544 | 11285654 | 1 | 20140710 | 201605 | 0 | |
| 112856544 | 11285654 | 2 | 201605 | 0 | ||
| 112856544 | 11285654 | 3 | 2013 | 0 |