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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116901983 | 11690198 | 3 | F | 201502 | 20160630 | 20151102 | 20160705 | EXP | VE-ABBVIE-15K-178-1489401-00 | ABBVIE | 27.25 | YR | F | Y | 63.00000 | KG | 20160705 | CN | COUNTRY NOT SPECIFIED | VE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116901983 | 11690198 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 116901983 | 11690198 | 2 | C | ENTEROGERMINA | BACILLUS SUBTILIS | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116901983 | 11690198 | 1 | Colitis ulcerative |
| 116901983 | 11690198 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116901983 | 11690198 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116901983 | 11690198 | Biopsy skin abnormal | |
| 116901983 | 11690198 | Dermatitis | |
| 116901983 | 11690198 | Melanocytic naevus | |
| 116901983 | 11690198 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 116901983 | 11690198 | 1 | 201410 | 201504 | 0 |