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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127263301 | 12726330 | 1 | I | 201602 | 20160806 | 20160908 | 20160908 | EXP | US-ABBVIE-16K-163-1699983-00 | ABBVIE | 27.48 | YR | F | Y | 61.29000 | KG | 20160908 | CN | COUNTRY NOT SPECIFIED | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127263301 | 12726330 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 1057214 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||
| 127263301 | 12726330 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 1057214 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||
| 127263301 | 12726330 | 3 | SS | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Unknown | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127263301 | 12726330 | 1 | Crohn's disease |
| 127263301 | 12726330 | 3 | Gastrointestinal infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127263301 | 12726330 | HO |
| 127263301 | 12726330 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127263301 | 12726330 | Gastrointestinal disorder | |
| 127263301 | 12726330 | Gastrointestinal infection | |
| 127263301 | 12726330 | Hypoaesthesia | |
| 127263301 | 12726330 | Localised infection | |
| 127263301 | 12726330 | Oedema peripheral | |
| 127263301 | 12726330 | Pain in extremity |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |