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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117528852 | 11752885 | 2 | F | 20150713 | 20160712 | 20151119 | 20160722 | EXP | CA-AMGEN-CANSP2015121181 | AMGEN | 46.00 | YR | A | F | Y | 0.00000 | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117528852 | 11752885 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 117528852 | 11752885 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 25 MG, QD | 0 | 25 | MG | QD | |||||||
| 117528852 | 11752885 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 117528852 | 11752885 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 117528852 | 11752885 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 25 MG, QWK | 0 | 25 | MG | /wk | |||||||
| 117528852 | 11752885 | 6 | SS | INDOCID | INDOMETHACIN | 1 | Unknown | UNK | 0 | ||||||||||
| 117528852 | 11752885 | 7 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | 400 MG, QD | 0 | 400 | MG | TABLET | QD | ||||||
| 117528852 | 11752885 | 8 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | 1 G, BID | 0 | 1 | G | BID | |||||||
| 117528852 | 11752885 | 9 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Oral | UNK | 0 | ||||||||||
| 117528852 | 11752885 | 10 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 117528852 | 11752885 | 11 | SS | RITUXAN | RITUXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 117528852 | 11752885 | 12 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 30 MG, QD AT NIGHTS | 0 | 30 | MG | QD | |||||||
| 117528852 | 11752885 | 13 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | UNK UNK, QWK | 0 | /wk | |||||||||
| 117528852 | 11752885 | 14 | 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 |
|---|---|---|---|
| 117528852 | 11752885 | 1 | Rheumatoid arthritis |
| 117528852 | 11752885 | 2 | Rheumatoid arthritis |
| 117528852 | 11752885 | 3 | Rheumatoid arthritis |
| 117528852 | 11752885 | 4 | Rheumatoid arthritis |
| 117528852 | 11752885 | 5 | Rheumatoid arthritis |
| 117528852 | 11752885 | 6 | Rheumatoid arthritis |
| 117528852 | 11752885 | 7 | Rheumatoid arthritis |
| 117528852 | 11752885 | 8 | Rheumatoid arthritis |
| 117528852 | 11752885 | 9 | Rheumatoid arthritis |
| 117528852 | 11752885 | 10 | Product used for unknown indication |
| 117528852 | 11752885 | 11 | Product used for unknown indication |
| 117528852 | 11752885 | 14 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117528852 | 11752885 | OT |
| 117528852 | 11752885 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117528852 | 11752885 | Anti-cyclic citrullinated peptide antibody positive | |
| 117528852 | 11752885 | Arthralgia | |
| 117528852 | 11752885 | Asthenia | |
| 117528852 | 11752885 | Bone density abnormal | |
| 117528852 | 11752885 | Disability | |
| 117528852 | 11752885 | Drug effect decreased | |
| 117528852 | 11752885 | Drug ineffective | |
| 117528852 | 11752885 | Joint stiffness | |
| 117528852 | 11752885 | Joint swelling | |
| 117528852 | 11752885 | Mood swings | |
| 117528852 | 11752885 | Musculoskeletal stiffness | |
| 117528852 | 11752885 | Neck deformity | |
| 117528852 | 11752885 | Neck mass | |
| 117528852 | 11752885 | Pain | |
| 117528852 | 11752885 | Rheumatoid arthritis | |
| 117528852 | 11752885 | Rheumatoid factor positive | |
| 117528852 | 11752885 | Treatment failure |
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 |
|---|---|---|---|---|---|---|
| 117528852 | 11752885 | 5 | 1997 | 0 | ||
| 117528852 | 11752885 | 14 | 20151126 | 0 |