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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127226951 | 12722695 | 1 | I | 20160404 | 20160704 | 20160907 | 20160907 | EXP | CA-ABBVIE-16K-028-1671456-00 | ABBVIE | 21.86 | YR | M | Y | 77.00000 | KG | 20160907 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127226951 | 12722695 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | /wk | ||||||
| 127226951 | 12722695 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | Oral | U | UNKNOWN | 0 | 20 | MG | QD | ||||||
| 127226951 | 12722695 | 3 | SS | IMURAN | AZATHIOPRINE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 127226951 | 12722695 | 4 | C | PREDNISONE. | PREDNISONE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127226951 | 12722695 | 1 | Crohn's disease |
| 127226951 | 12722695 | 2 | Rectal haemorrhage |
| 127226951 | 12722695 | 3 | Product used for unknown indication |
| 127226951 | 12722695 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127226951 | 12722695 | HO |
| 127226951 | 12722695 | OT |
| 127226951 | 12722695 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127226951 | 12722695 | Drug-induced liver injury | |
| 127226951 | 12722695 | Faecal calprotectin increased | |
| 127226951 | 12722695 | Fatigue | |
| 127226951 | 12722695 | Nausea | |
| 127226951 | 12722695 | Rectal haemorrhage | |
| 127226951 | 12722695 | 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 |
|---|---|---|---|---|---|---|
| 127226951 | 12722695 | 1 | 20130220 | 0 | ||
| 127226951 | 12722695 | 2 | 201606 | 0 |