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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117342883 | 11734288 | 3 | F | 2015 | 20160714 | 20151113 | 20160719 | EXP | CA-AMGEN-CANSP2015119854 | AMGEN | 77.00 | YR | E | F | Y | 0.00000 | 20160719 | OT | CA | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117342883 | 11734288 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 117342883 | 11734288 | 2 | SS | PROLIA | DENOSUMAB | 1 | Unknown | UNK | U | 0 | UNKNOWN FORMULATION | ||||||||
| 117342883 | 11734288 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 117342883 | 11734288 | 4 | SS | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | Unknown | 400 MG, UNK | 0 | 400 | MG | ||||||||
| 117342883 | 11734288 | 5 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 117342883 | 11734288 | 6 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 117342883 | 11734288 | 7 | SS | ORENCIA | ABATACEPT | 1 | Subcutaneous | 125 MG, UNK | 0 | 125 | MG | ||||||||
| 117342883 | 11734288 | 8 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 117342883 | 11734288 | 9 | C | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 5 MG, BID | 0 | 5 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117342883 | 11734288 | 1 | Rheumatoid arthritis |
| 117342883 | 11734288 | 2 | Product used for unknown indication |
| 117342883 | 11734288 | 3 | Rheumatoid arthritis |
| 117342883 | 11734288 | 4 | Rheumatoid arthritis |
| 117342883 | 11734288 | 5 | Rheumatoid arthritis |
| 117342883 | 11734288 | 6 | Rheumatoid arthritis |
| 117342883 | 11734288 | 7 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117342883 | 11734288 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117342883 | 11734288 | Abdominal pain | |
| 117342883 | 11734288 | Abdominal pain upper | |
| 117342883 | 11734288 | Aggression | |
| 117342883 | 11734288 | Alopecia | |
| 117342883 | 11734288 | Anxiety | |
| 117342883 | 11734288 | Arthralgia | |
| 117342883 | 11734288 | Asthenia | |
| 117342883 | 11734288 | Blood creatinine increased | |
| 117342883 | 11734288 | Cough | |
| 117342883 | 11734288 | Diarrhoea | |
| 117342883 | 11734288 | Drug ineffective | |
| 117342883 | 11734288 | Drug intolerance | |
| 117342883 | 11734288 | Dyspnoea | |
| 117342883 | 11734288 | Increased upper airway secretion | |
| 117342883 | 11734288 | Insomnia | |
| 117342883 | 11734288 | Joint swelling | |
| 117342883 | 11734288 | Lung disorder | |
| 117342883 | 11734288 | Malaise | |
| 117342883 | 11734288 | Peripheral swelling | |
| 117342883 | 11734288 | Productive cough | |
| 117342883 | 11734288 | Retinopathy | |
| 117342883 | 11734288 | Secretion discharge | |
| 117342883 | 11734288 | Sinus disorder | |
| 117342883 | 11734288 | Sinusitis | |
| 117342883 | 11734288 | Synovitis | |
| 117342883 | 11734288 | Tachyphylaxis | |
| 117342883 | 11734288 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 117342883 | 11734288 | 1 | 20110707 | 0 | ||
| 117342883 | 11734288 | 2 | 201501 | 0 | ||
| 117342883 | 11734288 | 9 | 20151220 | 0 |