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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116317605 | 11631760 | 5 | F | 20150903 | 20160721 | 20151015 | 20160728 | EXP | JP-ROCHE-1646491 | ROCHE | 78.78 | YR | M | Y | 57.00000 | KG | 20160728 | PH | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116317605 | 11631760 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Subcutaneous | U | 125472 | 162 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW | ||||||
| 116317605 | 11631760 | 2 | SS | PRALIA | DENOSUMAB | 1 | Subcutaneous | N | 0 | 60 | MG | QD | |||||||
| 116317605 | 11631760 | 3 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | FRACTIONATION DOSE UNCERTAIN FREQUENCY AND DOSE INTERVAL UNCERTAINTY | 0 | 2.5 | MG | ||||||||
| 116317605 | 11631760 | 4 | C | BISOPROLOL | BISOPROLOL | 1 | Oral | AMOUNT OF 1 ONCE ADMINISTRATION: 2.5 (UNIT UNCERTAINTY) | 0 | QD | |||||||||
| 116317605 | 11631760 | 5 | C | BAYASPIRIN | ASPIRIN | 1 | Oral | 0 | 100 | MG | QD | ||||||||
| 116317605 | 11631760 | 6 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 0 | 25 | MG | QD | ||||||||
| 116317605 | 11631760 | 7 | C | RABEPRAZOLE SODIUM. | RABEPRAZOLE SODIUM | 1 | Oral | 0 | 10 | MG | QD | ||||||||
| 116317605 | 11631760 | 8 | C | DIART | AZOSEMIDE | 1 | Oral | 0 | 30 | MG | QD | ||||||||
| 116317605 | 11631760 | 9 | C | WARFARIN | WARFARIN | 1 | Unknown | 0 | 2 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116317605 | 11631760 | 1 | Rheumatoid arthritis |
| 116317605 | 11631760 | 2 | Osteoporosis |
| 116317605 | 11631760 | 4 | Cardiac failure chronic |
| 116317605 | 11631760 | 5 | Arterial occlusive disease |
| 116317605 | 11631760 | 6 | Cardiac failure chronic |
| 116317605 | 11631760 | 7 | Prophylaxis |
| 116317605 | 11631760 | 8 | Cardiac failure chronic |
| 116317605 | 11631760 | 9 | Atrial fibrillation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116317605 | 11631760 | HO |
| 116317605 | 11631760 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116317605 | 11631760 | Gastrointestinal amyloidosis | |
| 116317605 | 11631760 | Hypoproteinaemia | |
| 116317605 | 11631760 | Infusion related reaction | |
| 116317605 | 11631760 | Malaise | |
| 116317605 | 11631760 | Oedema peripheral | |
| 116317605 | 11631760 | Pleural effusion |
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 |
|---|---|---|---|---|---|---|
| 116317605 | 11631760 | 1 | 20150903 | 20150903 | 0 | |
| 116317605 | 11631760 | 2 | 20150903 | 20150903 | 0 | |
| 116317605 | 11631760 | 4 | 201503 | 0 | ||
| 116317605 | 11631760 | 5 | 20121126 | 0 | ||
| 116317605 | 11631760 | 6 | 201501 | 0 | ||
| 116317605 | 11631760 | 7 | 201503 | 0 | ||
| 116317605 | 11631760 | 8 | 201503 | 0 | ||
| 116317605 | 11631760 | 9 | 20091127 | 0 |