The Safety Rates Drug Report

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Drug     Injury     Quarter    

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
105824792 10582479 2 F 20140807 20160714 20141113 20160719 EXP US-TAKEDA-2014MPI002975 TAKEDA 55.00 YR F Y 79.37000 KG 20160719 OT US US

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
105824792 10582479 1 PS VELCADE BORTEZOMIB 1 Subcutaneous 1.5 MG/M2 21602 1.5 MG/M**2 INJECTION /wk
105824792 10582479 2 SS VELCADE BORTEZOMIB 1 Intravenous (not otherwise specified) 1 MG/M2 21602 1 MG/M**2 INJECTION
105824792 10582479 3 SS DEXAMETHASONE. DEXAMETHASONE 1 Oral 40 MG 0 40 MG /wk
105824792 10582479 4 SS DEXAMETHASONE. DEXAMETHASONE 1 Oral 40 MG 0 40 MG
105824792 10582479 5 SS THALIDOMIDE THALIDOMIDE 1 Oral 50 MG, QD 4950 MG 0 50 MG QD
105824792 10582479 6 SS THALIDOMIDE THALIDOMIDE 1 Oral 200 MG 4950 MG 0 200 MG
105824792 10582479 7 SS CYTOXAN CYCLOPHOSPHAMIDE 1 Oral 300 MG/M2 0 300 MG/M**2 /wk
105824792 10582479 8 SS CYTOXAN CYCLOPHOSPHAMIDE 1 Intravenous (not otherwise specified) 400 MG/M2 0 400 MG/M**2
105824792 10582479 9 SS DOXORUBICIN HYDROCHLORIDE. DOXORUBICIN HYDROCHLORIDE 1 Intravenous (not otherwise specified) 10 MG/M2 0 10 MG/M**2
105824792 10582479 10 SS CISPLATIN. CISPLATIN 1 Intravenous (not otherwise specified) 10 MG/M2 0 10 MG/M**2
105824792 10582479 11 SS ETOPOSIDE. ETOPOSIDE 1 Intravenous (not otherwise specified) 10 MG/M2 0 10 MG/M**2

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
105824792 10582479 1 Plasma cell myeloma
105824792 10582479 3 Plasma cell myeloma
105824792 10582479 5 Plasma cell myeloma
105824792 10582479 7 Plasma cell myeloma
105824792 10582479 9 Plasma cell myeloma
105824792 10582479 10 Plasma cell myeloma
105824792 10582479 11 Plasma cell myeloma

Outcome of event

Event ID CASEID OUTC COD
105824792 10582479 DE
105824792 10582479 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
105824792 10582479 Back pain
105824792 10582479 Death
105824792 10582479 Mucosal inflammation

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
105824792 10582479 1 20140430 20140806 0
105824792 10582479 2 20140812 20140823 0
105824792 10582479 3 20140630 20140806 0
105824792 10582479 4 20140812 20140823 0
105824792 10582479 5 20140430 20140806 0
105824792 10582479 6 20140812 20140823 0
105824792 10582479 7 20140430 20140806 0
105824792 10582479 8 20140812 20140823 0
105824792 10582479 9 20140812 20140823 0
105824792 10582479 10 20140812 20140823 0
105824792 10582479 11 20140812 20140823 0