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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114143376 | 11414337 | 6 | F | 2015 | 20160711 | 20150824 | 20160804 | EXP | IL-ABBVIE-15K-082-1447129-00 | ABBVIE | 42.63 | YR | M | Y | 0.00000 | 20160804 | CN | COUNTRY NOT SPECIFIED | IL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114143376 | 11414337 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | ||||
| 114143376 | 11414337 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | ||||
| 114143376 | 11414337 | 3 | SS | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114143376 | 11414337 | 1 | Crohn's disease |
| 114143376 | 11414337 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114143376 | 11414337 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114143376 | 11414337 | Abdominal pain | |
| 114143376 | 11414337 | Abscess intestinal | |
| 114143376 | 11414337 | Crohn's disease | |
| 114143376 | 11414337 | Inflammatory marker increased | |
| 114143376 | 11414337 | Nausea | |
| 114143376 | 11414337 | Purulence |
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 |
|---|---|---|---|---|---|---|
| 114143376 | 11414337 | 1 | 201505 | 201509 | 0 | |
| 114143376 | 11414337 | 2 | 20160518 | 0 | ||
| 114143376 | 11414337 | 3 | 2016 | 2016 | 0 |