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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116868244 | 11686824 | 4 | F | 2015 | 20160707 | 20151030 | 20160715 | EXP | BR-ABBVIE-15K-020-1488731-00 | ABBVIE | 38.75 | YR | F | Y | 86.00000 | KG | 20160715 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116868244 | 11686824 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 44014XH01,581181XHOI | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 116868244 | 11686824 | 2 | C | METHOTREXATE. | METHOTREXATE | 1 | Oral | 0 | 4 | DF | TABLET | /wk | |||||||
| 116868244 | 11686824 | 3 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | TABLET | ||||||||||
| 116868244 | 11686824 | 4 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 | TABLET | ||||||||||
| 116868244 | 11686824 | 5 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | Oral | 0 | CAPSULE | ||||||||||
| 116868244 | 11686824 | 6 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | 0 | ||||||||||||
| 116868244 | 11686824 | 7 | C | DIPYRONE | DIPYRONE | 1 | Oral | 0 | 40 | GTT | ORAL DROPS | Q6H | |||||||
| 116868244 | 11686824 | 8 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 5 | MG | TABLET | ||||||||
| 116868244 | 11686824 | 9 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | Oral | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116868244 | 11686824 | 1 | Rheumatoid arthritis |
| 116868244 | 11686824 | 2 | Arthritis |
| 116868244 | 11686824 | 3 | Gastric disorder |
| 116868244 | 11686824 | 4 | Pain |
| 116868244 | 11686824 | 5 | Vitamin supplementation |
| 116868244 | 11686824 | 6 | Bone disorder |
| 116868244 | 11686824 | 7 | Pain |
| 116868244 | 11686824 | 8 | Pain |
| 116868244 | 11686824 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116868244 | 11686824 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116868244 | 11686824 | Asthenia | |
| 116868244 | 11686824 | Burning sensation | |
| 116868244 | 11686824 | Deafness unilateral | |
| 116868244 | 11686824 | Dysgeusia | |
| 116868244 | 11686824 | Dyspepsia | |
| 116868244 | 11686824 | Erythema | |
| 116868244 | 11686824 | Fluid intake reduced | |
| 116868244 | 11686824 | Gastrointestinal bacterial infection | |
| 116868244 | 11686824 | Head discomfort | |
| 116868244 | 11686824 | Hepatitis | |
| 116868244 | 11686824 | Inadequate diet | |
| 116868244 | 11686824 | Oedema peripheral | |
| 116868244 | 11686824 | Pain in extremity | |
| 116868244 | 11686824 | Pruritus | |
| 116868244 | 11686824 | Rash macular | |
| 116868244 | 11686824 | Tendonitis | |
| 116868244 | 11686824 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 116868244 | 11686824 | 1 | 20141107 | 20160320 | 0 | |
| 116868244 | 11686824 | 2 | 2008 | 0 | ||
| 116868244 | 11686824 | 4 | 2008 | 0 |