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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111136055 | 11113605 | 5 | F | 20150316 | 20160726 | 20150514 | 20160803 | EXP | DE-ABBVIE-15K-062-1390517-00 | ABBVIE | 36.66 | YR | F | Y | 0.00000 | 20160803 | CN | COUNTRY NOT SPECIFIED | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111136055 | 11113605 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 52081XD01,61144XD07 | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | ||||||
| 111136055 | 11113605 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 52081XD01,61144XD07 | 125057 | SOLUTION FOR INJECTION IN PRE-FILLED PEN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111136055 | 11113605 | 1 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111136055 | 11113605 | HO |
| 111136055 | 11113605 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111136055 | 11113605 | Abdominal pain | |
| 111136055 | 11113605 | Arthralgia | |
| 111136055 | 11113605 | Drug specific antibody present | |
| 111136055 | 11113605 | Gastrointestinal pain | |
| 111136055 | 11113605 | Intestinal stenosis | |
| 111136055 | 11113605 | Joint range of motion decreased | |
| 111136055 | 11113605 | Lupus-like syndrome | |
| 111136055 | 11113605 | Mobility decreased | |
| 111136055 | 11113605 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 111136055 | 11113605 | 1 | 201410 | 20151019 | 0 | |
| 111136055 | 11113605 | 2 | 20151127 | 20160702 | 0 |