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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107924504 | 10792450 | 4 | F | 20120101 | 20160725 | 20150213 | 20160802 | EXP | BR-ABBVIE-15K-020-1343166-00 | ABBVIE | 37.61 | YR | F | Y | 87.00000 | KG | 20160802 | OT | COUNTRY NOT SPECIFIED | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107924504 | 10792450 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 41489XH01,50061XH01 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 107924504 | 10792450 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 41489XH01,50061XH01 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 107924504 | 10792450 | 3 | SS | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | Oral | USED ONLY ONCE | Y | UNKNOWN | 0 | TABLET | |||||||
| 107924504 | 10792450 | 4 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Oral | 0 | TABLET | QD | |||||||||
| 107924504 | 10792450 | 5 | C | NEOVLAR | 2 | Oral | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 107924504 | 10792450 | 1 | Crohn's disease |
| 107924504 | 10792450 | 3 | Product used for unknown indication |
| 107924504 | 10792450 | 4 | Crohn's disease |
| 107924504 | 10792450 | 5 | Contraception |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 107924504 | 10792450 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 107924504 | 10792450 | Abdominal distension | |
| 107924504 | 10792450 | Abdominal pain upper | |
| 107924504 | 10792450 | Burning sensation | |
| 107924504 | 10792450 | Contusion | |
| 107924504 | 10792450 | Diarrhoea | |
| 107924504 | 10792450 | Drug dose omission | |
| 107924504 | 10792450 | Drug hypersensitivity | |
| 107924504 | 10792450 | Erythema | |
| 107924504 | 10792450 | Fatigue | |
| 107924504 | 10792450 | Food allergy | |
| 107924504 | 10792450 | Generalised erythema | |
| 107924504 | 10792450 | Injection site pain | |
| 107924504 | 10792450 | Malaise | |
| 107924504 | 10792450 | Paraesthesia | |
| 107924504 | 10792450 | Perfume sensitivity | |
| 107924504 | 10792450 | Pruritus allergic | |
| 107924504 | 10792450 | Pyrexia | |
| 107924504 | 10792450 | Skin haemorrhage | |
| 107924504 | 10792450 | Somnolence | |
| 107924504 | 10792450 | Weight decreased | |
| 107924504 | 10792450 | Wound |
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 |
|---|---|---|---|---|---|---|
| 107924504 | 10792450 | 1 | 20120101 | 0 | ||
| 107924504 | 10792450 | 3 | 201305 | 201305 | 0 | |
| 107924504 | 10792450 | 4 | 201406 | 0 | ||
| 107924504 | 10792450 | 5 | 2000 | 0 |