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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108410825 | 10841082 | 5 | F | 2002 | 20160804 | 20150220 | 20160818 | EXP | BR-AMGEN-BRACT2012038812 | AMGEN | 59.00 | YR | A | F | Y | 60.00000 | KG | 20160817 | CN | BR | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108410825 | 10841082 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, WEEKLY | Y | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 108410825 | 10841082 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, WEEKLY | Y | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 108410825 | 10841082 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 5 MG, DAILY | 0 | 5 | MG | ||||||||
| 108410825 | 10841082 | 4 | C | METHOTREXATE. | METHOTREXATE | 1 | 17.5 MG, WEEKLY | 0 | 17.5 | MG | TABLET | /wk | |||||||
| 108410825 | 10841082 | 5 | C | METHOTREXATE. | METHOTREXATE | 1 | 17.5 MG, WEEKLY | 0 | 17.5 | MG | TABLET | /wk | |||||||
| 108410825 | 10841082 | 6 | C | METHOTREXATE. | METHOTREXATE | 1 | 17.5 MG, WEEKLY | 0 | 17.5 | MG | TABLET | /wk | |||||||
| 108410825 | 10841082 | 7 | C | RAMIPRIL. | RAMIPRIL | 1 | 5 MG , 1X/DAY | 0 | 5 | MG | TABLET | QD | |||||||
| 108410825 | 10841082 | 8 | C | ATORVASTATIN | ATORVASTATIN | 1 | 20 MG , 1X/DAY | 0 | 20 | MG | TABLET | QD | |||||||
| 108410825 | 10841082 | 9 | C | ATORVASTATIN | ATORVASTATIN | 1 | 20 MG , 1X/DAY | 0 | 20 | MG | TABLET | QD | |||||||
| 108410825 | 10841082 | 10 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | 0 | |||||||||||
| 108410825 | 10841082 | 11 | C | CALCIUM | CALCIUM | 1 | UNK | 0 | |||||||||||
| 108410825 | 10841082 | 12 | C | OMEPRAZOL | OMEPRAZOLE | 1 | UNK | 0 | |||||||||||
| 108410825 | 10841082 | 13 | C | ATORVASTATIN CALCIUM. | ATORVASTATIN CALCIUM | 1 | UNK | 0 | |||||||||||
| 108410825 | 10841082 | 14 | C | ATORVASTATIN CALCIUM. | ATORVASTATIN CALCIUM | 1 | UNK | 0 | |||||||||||
| 108410825 | 10841082 | 15 | C | ATORVASTATIN CALCIUM. | ATORVASTATIN CALCIUM | 1 | 20 MG , 1X/DAY | 0 | 20 | MG | QD | ||||||||
| 108410825 | 10841082 | 16 | C | LORATADINE. | LORATADINE | 1 | UNK | 0 | |||||||||||
| 108410825 | 10841082 | 17 | C | LORATADINE. | LORATADINE | 1 | UNK | 0 | |||||||||||
| 108410825 | 10841082 | 18 | C | LORATADINE. | LORATADINE | 1 | UNK | 0 | |||||||||||
| 108410825 | 10841082 | 19 | C | ARAVA | LEFLUNOMIDE | 1 | 20 MG , 1X/DAY | 0 | 20 | MG | QD | ||||||||
| 108410825 | 10841082 | 20 | C | ARAVA | LEFLUNOMIDE | 1 | 20 MG , 1X/DAY | 0 | 20 | MG | QD | ||||||||
| 108410825 | 10841082 | 21 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | 80 MG , 1X/DAY | 0 | 80 | MG | QD | ||||||||
| 108410825 | 10841082 | 22 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | 80 MG , 1X/DAY | 0 | 80 | MG | QD | ||||||||
| 108410825 | 10841082 | 23 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | 80 MG , 1X/DAY | 0 | 80 | MG | QD | ||||||||
| 108410825 | 10841082 | 24 | C | SIMVASTATIN. | SIMVASTATIN | 1 | UNK | 0 | |||||||||||
| 108410825 | 10841082 | 25 | C | OMEPRAZOL | OMEPRAZOLE | 1 | UNK | 0 | |||||||||||
| 108410825 | 10841082 | 26 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | UNK | 0 | |||||||||||
| 108410825 | 10841082 | 27 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108410825 | 10841082 | 1 | Rheumatoid arthritis |
| 108410825 | 10841082 | 3 | Rheumatoid arthritis |
| 108410825 | 10841082 | 7 | Blood pressure abnormal |
| 108410825 | 10841082 | 21 | Antidepressant therapy |
| 108410825 | 10841082 | 24 | Blood cholesterol abnormal |
| 108410825 | 10841082 | 26 | Gastritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 108410825 | 10841082 | HO |
| 108410825 | 10841082 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108410825 | 10841082 | Blood glucose abnormal | |
| 108410825 | 10841082 | Condition aggravated | |
| 108410825 | 10841082 | Crying | |
| 108410825 | 10841082 | Decreased immune responsiveness | |
| 108410825 | 10841082 | Depression | |
| 108410825 | 10841082 | Dermatitis allergic | |
| 108410825 | 10841082 | Dislocation of vertebra | |
| 108410825 | 10841082 | Drug ineffective | |
| 108410825 | 10841082 | Dyspnoea | |
| 108410825 | 10841082 | Erythema | |
| 108410825 | 10841082 | Feeling abnormal | |
| 108410825 | 10841082 | Fungal skin infection | |
| 108410825 | 10841082 | Herpes virus infection | |
| 108410825 | 10841082 | Hypersensitivity | |
| 108410825 | 10841082 | Hypothyroidism | |
| 108410825 | 10841082 | Inflammation | |
| 108410825 | 10841082 | Intervertebral disc injury | |
| 108410825 | 10841082 | Intervertebral disc protrusion | |
| 108410825 | 10841082 | Miliaria | |
| 108410825 | 10841082 | Neuritis | |
| 108410825 | 10841082 | Opportunistic infection | |
| 108410825 | 10841082 | Osteopenia | |
| 108410825 | 10841082 | Pain | |
| 108410825 | 10841082 | Pharyngeal oedema | |
| 108410825 | 10841082 | Rheumatoid arthritis | |
| 108410825 | 10841082 | Tendon rupture | |
| 108410825 | 10841082 | Throat tightness | |
| 108410825 | 10841082 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 108410825 | 10841082 | 1 | 201111 | 2012 | 0 | |
| 108410825 | 10841082 | 2 | 2013 | 2014 | 0 | |
| 108410825 | 10841082 | 3 | 1996 | 0 | ||
| 108410825 | 10841082 | 6 | 2012 | 0 | ||
| 108410825 | 10841082 | 7 | 2003 | 0 | ||
| 108410825 | 10841082 | 15 | 2004 | 0 | ||
| 108410825 | 10841082 | 20 | 2015 | 0 | ||
| 108410825 | 10841082 | 23 | 2012 | 0 | ||
| 108410825 | 10841082 | 24 | 2003 | 0 | ||
| 108410825 | 10841082 | 26 | 1998 | 0 |