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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
118052042 | 11805204 | 2 | F | 20151124 | 20151206 | 20160720 | EXP | IT-MYLANLABS-2015M1043171 | MYLAN | RAMIREZ GA, CAMPOCHIARO C, SALMAGGI C, PAGLIULA G, D^ALIBERTI T, MARCATTI M, ET AL. BORTEZOMIB IN TYPE I CRYOGLOBULINEMIC VASCULITIS: ARE WE ACTING TOO LATE?. INTERN-MED 2015; 54(9):1119-1123. | 0.00 | Y | 0.00000 | 20160720 | OT | IT | IT |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
118052042 | 11805204 | 1 | PS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 40 MG ON DAYS 1-2, 4-5, 8-9 AND11-12 EVERY 21 DAYS | U | U | 40802 | ||||||||
118052042 | 11805204 | 2 | SS | BORTEZOMIB | BORTEZOMIB | 1 | Subcutaneous | 1.3MG/M2 ON DAYS 1, 4, 8 AND 11 EVERY 21 DAYS. | Y | N | 0 | INJECTION | |||||||
118052042 | 11805204 | 3 | C | PREDNISONE. | PREDNISONE | 1 | 1 MG/KG WITH PROGRESSIVE TAPERING | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
118052042 | 11805204 | 1 | Cryoglobulinaemia |
118052042 | 11805204 | 2 | Cryoglobulinaemia |
118052042 | 11805204 | 3 | Cryoglobulinaemia |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
118052042 | 11805204 | Diarrhoea | |
118052042 | 11805204 | Neuralgia | |
118052042 | 11805204 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |