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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116164885 | 11616488 | 5 | F | 20160909 | 20151009 | 20160912 | EXP | CA-ROCHE-1642324 | ROCHE | 74.00 | YR | F | Y | 0.00000 | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116164885 | 11616488 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | N | 125276 | SOLUTION FOR INFUSION | |||||||||
| 116164885 | 11616488 | 2 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | U | 0 | 15 | MG | /wk | |||||||
| 116164885 | 11616488 | 3 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116164885 | 11616488 | 1 | Rheumatoid arthritis |
| 116164885 | 11616488 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116164885 | 11616488 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116164885 | 11616488 | Alopecia | |
| 116164885 | 11616488 | Arthropathy | |
| 116164885 | 11616488 | Back pain | |
| 116164885 | 11616488 | Blood cholesterol increased | |
| 116164885 | 11616488 | Cough | |
| 116164885 | 11616488 | Drug effect incomplete | |
| 116164885 | 11616488 | Drug ineffective | |
| 116164885 | 11616488 | Gait disturbance | |
| 116164885 | 11616488 | Haematotoxicity | |
| 116164885 | 11616488 | Haemoglobin decreased | |
| 116164885 | 11616488 | Hepatotoxicity | |
| 116164885 | 11616488 | Joint swelling | |
| 116164885 | 11616488 | Mean cell haemoglobin concentration decreased | |
| 116164885 | 11616488 | Musculoskeletal disorder | |
| 116164885 | 11616488 | Neutrophil count decreased | |
| 116164885 | 11616488 | Oedema | |
| 116164885 | 11616488 | Pain | |
| 116164885 | 11616488 | Paraesthesia | |
| 116164885 | 11616488 | Post procedural infection | |
| 116164885 | 11616488 | Productive cough | |
| 116164885 | 11616488 | Red cell distribution width increased | |
| 116164885 | 11616488 | Swelling face | |
| 116164885 | 11616488 | Synovitis | |
| 116164885 | 11616488 | Tenderness |
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 |
|---|---|---|---|---|---|---|
| 116164885 | 11616488 | 1 | 2012 | 2015 | 0 | |
| 116164885 | 11616488 | 2 | 200703 | 20160623 | 0 | |
| 116164885 | 11616488 | 3 | 20150922 | 0 |