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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118038452 | 11803845 | 2 | F | 2015 | 20160704 | 20151204 | 20160712 | EXP | CA-ABBVIE-15K-028-1470069-00 | ABBVIE | 0.00 | M | Y | 80.36000 | KG | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118038452 | 11803845 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | N | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||
| 118038452 | 11803845 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | N | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118038452 | 11803845 | 1 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118038452 | 11803845 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118038452 | 11803845 | Crohn's disease | |
| 118038452 | 11803845 | Eating disorder | |
| 118038452 | 11803845 | Feeling abnormal | |
| 118038452 | 11803845 | Intestinal obstruction | |
| 118038452 | 11803845 | Weight decreased | |
| 118038452 | 11803845 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 118038452 | 11803845 | 1 | 20131230 | 2015 | 0 | |
| 118038452 | 11803845 | 2 | 201601 | 0 |