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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100318905 | 10031890 | 5 | F | 2012 | 20160920 | 20140324 | 20160923 | EXP | BR-ABBVIE-12P-020-1000383-00 | ABBVIE | 67.73 | YR | F | Y | 60.00000 | KG | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100318905 | 10031890 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 100318905 | 10031890 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 100318905 | 10031890 | 3 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 100318905 | 10031890 | 4 | C | ATENOLOL. | ATENOLOL | 1 | Oral | 0 | 25 | MG | TABLET | BID | |||||||
| 100318905 | 10031890 | 5 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | Oral | 0 | 50 | MG | TABLET | BID | |||||||
| 100318905 | 10031890 | 6 | C | PREDSIM | PREDNISOLONE | 1 | Oral | 0 | 5 | MG | TABLET | BID | |||||||
| 100318905 | 10031890 | 7 | C | PREDSIM | PREDNISOLONE | 1 | 0 | ||||||||||||
| 100318905 | 10031890 | 8 | C | MELOXICAM. | MELOXICAM | 1 | Oral | 0 | TABLET | ||||||||||
| 100318905 | 10031890 | 9 | C | MELOXICAM. | MELOXICAM | 1 | Oral | 0 | TABLET | ||||||||||
| 100318905 | 10031890 | 10 | C | OSTEOFORM | 2 | Oral | 0 | TABLET | /wk | ||||||||||
| 100318905 | 10031890 | 11 | C | ARAVA | LEFLUNOMIDE | 1 | Oral | AFTER DINNER | 0 | TABLET | |||||||||
| 100318905 | 10031890 | 12 | C | PREDSIM | PREDNISOLONE | 1 | Oral | 0 | TABLET | ||||||||||
| 100318905 | 10031890 | 13 | C | OSTEOFORM | 2 | Oral | 0 | 70 | MG | TABLET | /wk | ||||||||
| 100318905 | 10031890 | 14 | C | OSTEOFORM | 2 | 0 | |||||||||||||
| 100318905 | 10031890 | 15 | C | CALDE | CALCIUM CARBONATECHOLECALCIFEROL | 1 | Oral | 0 | TABLET | ||||||||||
| 100318905 | 10031890 | 16 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | TABLET | ||||||||||
| 100318905 | 10031890 | 17 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 100318905 | 10031890 | 18 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 100318905 | 10031890 | 19 | C | OSCAL D | CALCIUM CARBONATECHOLECALCIFEROL | 1 | Oral | AFTER LUNCH | 0 | TABLET | |||||||||
| 100318905 | 10031890 | 20 | C | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | AFTER LUNCH | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 100318905 | 10031890 | 1 | Rheumatoid arthritis |
| 100318905 | 10031890 | 3 | Product used for unknown indication |
| 100318905 | 10031890 | 4 | Hypertension |
| 100318905 | 10031890 | 5 | Hypertension |
| 100318905 | 10031890 | 6 | Antiinflammatory therapy |
| 100318905 | 10031890 | 7 | Rheumatoid arthritis |
| 100318905 | 10031890 | 8 | Rheumatoid arthritis |
| 100318905 | 10031890 | 9 | Pain |
| 100318905 | 10031890 | 10 | Osteoporosis |
| 100318905 | 10031890 | 11 | Rheumatoid arthritis |
| 100318905 | 10031890 | 12 | Pain |
| 100318905 | 10031890 | 13 | Mineral supplementation |
| 100318905 | 10031890 | 14 | Osteoporosis |
| 100318905 | 10031890 | 15 | Mineral supplementation |
| 100318905 | 10031890 | 16 | Gastric disorder |
| 100318905 | 10031890 | 17 | Gastric disorder |
| 100318905 | 10031890 | 18 | Prophylaxis |
| 100318905 | 10031890 | 19 | Osteoporosis |
| 100318905 | 10031890 | 20 | Thrombosis prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 100318905 | 10031890 | DS |
| 100318905 | 10031890 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 100318905 | 10031890 | Anaemia | |
| 100318905 | 10031890 | Cerebral haematoma | |
| 100318905 | 10031890 | Cerebral thrombosis | |
| 100318905 | 10031890 | Cervical cord compression | |
| 100318905 | 10031890 | Dropped head syndrome | |
| 100318905 | 10031890 | Dysstasia | |
| 100318905 | 10031890 | Gait disturbance | |
| 100318905 | 10031890 | Head injury | |
| 100318905 | 10031890 | Intervertebral disc protrusion | |
| 100318905 | 10031890 | Loss of consciousness | |
| 100318905 | 10031890 | Monoparesis | |
| 100318905 | 10031890 | Monoplegia | |
| 100318905 | 10031890 | Paresis | |
| 100318905 | 10031890 | Rheumatoid arthritis | |
| 100318905 | 10031890 | Spinal disorder |
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 |
|---|---|---|---|---|---|---|
| 100318905 | 10031890 | 1 | 20120717 | 2013 | 0 | |
| 100318905 | 10031890 | 2 | 201406 | 0 | ||
| 100318905 | 10031890 | 4 | 2013 | 0 | ||
| 100318905 | 10031890 | 5 | 2013 | 0 | ||
| 100318905 | 10031890 | 6 | 2006 | 0 | ||
| 100318905 | 10031890 | 8 | 2006 | 0 | ||
| 100318905 | 10031890 | 9 | 2011 | 0 | ||
| 100318905 | 10031890 | 10 | 2006 | 0 | ||
| 100318905 | 10031890 | 11 | 2011 | 0 | ||
| 100318905 | 10031890 | 12 | 2006 | 0 | ||
| 100318905 | 10031890 | 13 | 2006 | 0 | ||
| 100318905 | 10031890 | 15 | 2011 | 0 | ||
| 100318905 | 10031890 | 16 | 2006 | 0 | ||
| 100318905 | 10031890 | 19 | 201404 | 0 | ||
| 100318905 | 10031890 | 20 | 20140823 | 0 |