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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124638832 | 12463883 | 2 | F | 20160708 | 20160614 | 20160718 | EXP | AU-ABBVIE-16K-008-1645506-00 | ABBVIE | 0.00 | M | Y | 0.00000 | 20160718 | CN | COUNTRY NOT SPECIFIED | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124638832 | 12463883 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION | QOW | ||||||
| 124638832 | 12463883 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION | /wk | ||||||
| 124638832 | 12463883 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 40MG X 4 | UNKNOWN | 125057 | 160 | MG | SOLUTION FOR INJECTION | ||||||
| 124638832 | 12463883 | 4 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 124638832 | 12463883 | 5 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | Y | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124638832 | 12463883 | 1 | Colitis ulcerative |
| 124638832 | 12463883 | 2 | Crohn's disease |
| 124638832 | 12463883 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124638832 | 12463883 | HO |
| 124638832 | 12463883 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124638832 | 12463883 | Coeliac disease | |
| 124638832 | 12463883 | Colitis ulcerative | |
| 124638832 | 12463883 | Crohn's disease | |
| 124638832 | 12463883 | Foot fracture | |
| 124638832 | 12463883 | Increased tendency to bruise | |
| 124638832 | 12463883 | Insomnia | |
| 124638832 | 12463883 | Localised infection | |
| 124638832 | 12463883 | Malaise | |
| 124638832 | 12463883 | Skin haemorrhage |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |