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
121426389 12142638 9 F 20150807 20160804 20160303 20160815 EXP BG-TAKEDA-2016MPI001498 TAKEDA 69.00 YR F Y 61.00000 KG 20160815 MD BG BG

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
121426389 12142638 1 PS VELCADE BORTEZOMIB 1 Subcutaneous 2.08 MG, 2/WEEK V14036-08;V14036-10 +MORE 21602 2.8 MG INJECTION BIW
121426389 12142638 2 SS VELCADE BORTEZOMIB 1 Subcutaneous 2.08 MG, UNK V14036-08;V14036-10 +MORE 21602 2.8 MG INJECTION BIW
121426389 12142638 3 SS VELCADE BORTEZOMIB 1 Subcutaneous 2.08 MG, UNK V14036-08;V14036-10 +MORE 21602 2.8 MG INJECTION
121426389 12142638 4 SS VELCADE BORTEZOMIB 1 Subcutaneous 2.08 MG, UNK V14036-08;V14036-10 +MORE 21602 2.8 MG INJECTION
121426389 12142638 5 SS VELCADE BORTEZOMIB 1 Subcutaneous 2.08 MG, UNK V14036-08;V14036-10 +MORE 21602 2.8 MG INJECTION
121426389 12142638 6 SS VELCADE BORTEZOMIB 1 Subcutaneous 2.08 MG, UNK V14036-08;V14036-10 +MORE 21602 2.8 MG INJECTION
121426389 12142638 7 SS VELCADE BORTEZOMIB 1 Subcutaneous 2.08 MG, UNK V14036-08;V14036-10 +MORE 21602 2.8 MG INJECTION
121426389 12142638 8 SS VELCADE BORTEZOMIB 1 Subcutaneous 2.08 MG, UNK V14036-08;V14036-10 +MORE 21602 2.8 MG INJECTION
121426389 12142638 9 SS VELCADE BORTEZOMIB 1 Subcutaneous 2.08 MG, UNK V14036-08;V14036-10 +MORE 21602 2.8 MG INJECTION
121426389 12142638 10 SS VELCADE BORTEZOMIB 1 Subcutaneous 2.08 MG, UNK V14036-08;V14036-10 +MORE 21602 2.8 MG INJECTION
121426389 12142638 11 SS VELCADE BORTEZOMIB 1 Subcutaneous 2.08 MG, UNK V14036-08;V14036-10 +MORE 21602 2.8 MG INJECTION
121426389 12142638 12 SS VELCADE BORTEZOMIB 1 Subcutaneous 2.08 MG, UNK V14036-08;V14036-10 +MORE 21602 2.8 MG INJECTION
121426389 12142638 13 SS VELCADE BORTEZOMIB 1 Subcutaneous 2.08 MG, UNK V14036-08;V14036-10 +MORE 21602 2.8 MG INJECTION
121426389 12142638 14 SS VELCADE BORTEZOMIB 1 Subcutaneous 2.08 MG, UNK V14036-08;V14036-10 +MORE 21602 2.8 MG INJECTION
121426389 12142638 15 SS PREDNISONE. PREDNISONE 1 Oral 100 MG, UNK 4370387 0 100 MG
121426389 12142638 16 SS PREDNISONE. PREDNISONE 1 Oral 100 MG, UNK 4370387 0 100 MG
121426389 12142638 17 SS PREDNISONE. PREDNISONE 1 Oral 100 MG, UNK 4370387 0 100 MG
121426389 12142638 18 SS DARATUMUMAB DARATUMUMAB 1 Intravenous (not otherwise specified) 976 MG, 1/WEEK 058998-01;058998-02 0 976 MG /wk
121426389 12142638 19 SS DARATUMUMAB DARATUMUMAB 1 Intravenous (not otherwise specified) 976 MG, UNK 058998-01;058998-02 0 976 MG
121426389 12142638 20 SS MELPHALAN MELPHALAN 1 Oral 14 MG, UNK 4370421 0 14 MG
121426389 12142638 21 SS MELPHALAN MELPHALAN 1 Oral 14 MG, UNK 4370421 0 14 MG
121426389 12142638 22 SS MELPHALAN MELPHALAN 1 Oral 14 MG, UNK 4370421 0 14 MG
121426389 12142638 23 SS MELPHALAN MELPHALAN 1 Oral 16 MG, UNK 0 16 MG
121426389 12142638 24 C MAXIPIM 2 Intravenous (not otherwise specified) 1000 MG, BID 14000 MG 0 1000 MG INJECTION BID
121426389 12142638 25 C MERONEM MEROPENEM 1 Intravenous (not otherwise specified) 2000 MG, TID 0 2000 MG INJECTION TID
121426389 12142638 26 C VORICONAZOLE. VORICONAZOLE 1 Intravenous (not otherwise specified) 200 MG, BID 2800 MG 0 200 MG INJECTION BID
121426389 12142638 27 C TEVAGRASTIM FILGRASTIM 1 Subcutaneous 300 ?G, UNK 0 300 UG INJECTION
121426389 12142638 28 C HUMAN ALBUMIN ALBUMIN HUMAN 1 Intravenous (not otherwise specified) 100 MG, UNK 0 100 MG INJECTION
121426389 12142638 29 C ACYCLOVIR /00587301/ ACYCLOVIR 1 Oral 400 MG, BID 21600 MG 0 400 MG TABLET BID
121426389 12142638 30 C BISEPTOL SULFAMETHOXAZOLETRIMETHOPRIM 1 Oral 960 MG, 2/WEEK 0 960 MG TABLET BIW

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
121426389 12142638 1 Plasma cell myeloma
121426389 12142638 15 Plasma cell myeloma
121426389 12142638 18 Plasma cell myeloma
121426389 12142638 20 Plasma cell myeloma
121426389 12142638 24 Neutropenia
121426389 12142638 25 Neutropenia
121426389 12142638 26 Neutropenia
121426389 12142638 27 Neutropenia
121426389 12142638 28 Hypoalbuminaemia
121426389 12142638 29 Prophylaxis
121426389 12142638 30 Prophylaxis

Outcome of event

Event ID CASEID OUTC COD
121426389 12142638 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
121426389 12142638 Anaemia
121426389 12142638 Hypoalbuminaemia
121426389 12142638 Neutropenia
121426389 12142638 Pleural effusion
121426389 12142638 Thrombocytopenia

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
121426389 12142638 1 20150724 0
121426389 12142638 2 20150727 0
121426389 12142638 3 20150731 0
121426389 12142638 4 20150803 0
121426389 12142638 5 20150814 0
121426389 12142638 6 20150817 0
121426389 12142638 7 20150821 0
121426389 12142638 8 20150824 0
121426389 12142638 9 20150904 0
121426389 12142638 10 20150911 0
121426389 12142638 11 20150925 0
121426389 12142638 12 20151002 0
121426389 12142638 13 20151016 0
121426389 12142638 14 20151023 0
121426389 12142638 15 20150724 20150727 0
121426389 12142638 16 20150905 20150907 0
121426389 12142638 17 20151017 20151019 0
121426389 12142638 18 20150724 0
121426389 12142638 19 20150814 0
121426389 12142638 20 20150724 20150727 0
121426389 12142638 21 20150904 20150907 0
121426389 12142638 22 20151016 20151019 0
121426389 12142638 23 20150726 20150727 0
121426389 12142638 24 20150818 20150824 0
121426389 12142638 25 20150825 20150828 0
121426389 12142638 26 20150818 20150824 0
121426389 12142638 27 20150818 20150826 0
121426389 12142638 28 20150818 20150820 0
121426389 12142638 29 20150729 20150826 0
121426389 12142638 30 20150729 20150826 0