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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116314048 | 11631404 | 8 | F | 20160906 | 20151014 | 20160908 | EXP | CA-ROCHE-1643958 | ROCHE | 0.00 | F | Y | 0.00000 | 20160908 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116314048 | 11631404 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 103705 | SOLUTION FOR INFUSION | ||||||||||
| 116314048 | 11631404 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125276 | 8 | MG/KG | SOLUTION FOR INFUSION | /month | ||||||
| 116314048 | 11631404 | 3 | SS | ORENCIA | ABATACEPT | 1 | Unknown | U | 0 | ||||||||||
| 116314048 | 11631404 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | U | 0 | ||||||||||
| 116314048 | 11631404 | 5 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Oral | U | 0 | 15 | MG | /wk | |||||||
| 116314048 | 11631404 | 6 | SS | ENBREL | ETANERCEPT | 1 | Unknown | U | 0 | ||||||||||
| 116314048 | 11631404 | 7 | SS | NAPROXEN. | NAPROXEN | 1 | Unknown | U | 17581 | ||||||||||
| 116314048 | 11631404 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | 5 | MG | QD | |||||||
| 116314048 | 11631404 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | 3 | MG | QD | |||||||
| 116314048 | 11631404 | 10 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | U | 0 | 15 | MG | /wk | |||||||
| 116314048 | 11631404 | 11 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | U | 0 | TABLET | |||||||||
| 116314048 | 11631404 | 12 | C | KETOPROFEN. | KETOPROFEN | 1 | Unknown | 0 | 100 | MG | BID | ||||||||
| 116314048 | 11631404 | 13 | C | LOSEC | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 116314048 | 11631404 | 14 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | 0 | ||||||||||||
| 116314048 | 11631404 | 15 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Unknown | 0 | |||||||||||
| 116314048 | 11631404 | 16 | C | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 0 | 5 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116314048 | 11631404 | 1 | Rheumatoid arthritis |
| 116314048 | 11631404 | 2 | Rheumatoid arthritis |
| 116314048 | 11631404 | 3 | Rheumatoid arthritis |
| 116314048 | 11631404 | 4 | Rheumatoid arthritis |
| 116314048 | 11631404 | 5 | Product used for unknown indication |
| 116314048 | 11631404 | 6 | Rheumatoid arthritis |
| 116314048 | 11631404 | 7 | Rheumatoid arthritis |
| 116314048 | 11631404 | 8 | Rheumatoid arthritis |
| 116314048 | 11631404 | 10 | Rheumatoid arthritis |
| 116314048 | 11631404 | 11 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116314048 | 11631404 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116314048 | 11631404 | Arthralgia | |
| 116314048 | 11631404 | Arthropathy | |
| 116314048 | 11631404 | Asthenia | |
| 116314048 | 11631404 | Condition aggravated | |
| 116314048 | 11631404 | Cough | |
| 116314048 | 11631404 | Drug ineffective | |
| 116314048 | 11631404 | Fatigue | |
| 116314048 | 11631404 | Fine motor skill dysfunction | |
| 116314048 | 11631404 | Goitre | |
| 116314048 | 11631404 | Headache | |
| 116314048 | 11631404 | Inflammation | |
| 116314048 | 11631404 | Joint swelling | |
| 116314048 | 11631404 | Lower respiratory tract infection | |
| 116314048 | 11631404 | Musculoskeletal pain | |
| 116314048 | 11631404 | Musculoskeletal stiffness | |
| 116314048 | 11631404 | Nasopharyngitis | |
| 116314048 | 11631404 | Nephrolithiasis | |
| 116314048 | 11631404 | Pain | |
| 116314048 | 11631404 | Pain in extremity | |
| 116314048 | 11631404 | Peripheral swelling | |
| 116314048 | 11631404 | Rheumatoid arthritis | |
| 116314048 | 11631404 | Swelling | |
| 116314048 | 11631404 | Thyroid 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 |
|---|---|---|---|---|---|---|
| 116314048 | 11631404 | 2 | 20150910 | 0 | ||
| 116314048 | 11631404 | 5 | 20150910 | 0 | ||
| 116314048 | 11631404 | 15 | 20150910 | 0 | ||
| 116314048 | 11631404 | 16 | 20151114 | 0 |