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
124784434 12478443 4 F 20160614 20160725 20160618 20160726 EXP AU-JNJFOC-20160614087 PHARMACYCLICS 82.64 YR Y 76.30000 KG 20160726 MD AU AU

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
124784434 12478443 1 PS IBRUTINIB IBRUTINIB 1 Oral N N 205552 560 MG CAPSULE QD
124784434 12478443 2 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Intravenous (not otherwise specified) EVERY 21 DAYS 0 760 MG POWDER FOR INJECTION
124784434 12478443 3 SS DOXORUBICIN DOXORUBICIN 1 Intravenous (not otherwise specified) EVERY 21 DAYS 0 47 MG SOLUTION
124784434 12478443 4 SS VINCRISTINE VINCRISTINE 1 Intravenous (not otherwise specified) EVERY 21 DAYS 0 1 MG SOLUTION
124784434 12478443 5 SS PREDNISONE. PREDNISONE 1 Oral 0 100 MG TABLET QD

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
124784434 12478443 1 Diffuse large B-cell lymphoma
124784434 12478443 2 Diffuse large B-cell lymphoma
124784434 12478443 3 Diffuse large B-cell lymphoma
124784434 12478443 4 Diffuse large B-cell lymphoma
124784434 12478443 5 Diffuse large B-cell lymphoma

Outcome of event

Event ID CASEID OUTC COD
124784434 12478443 LT
124784434 12478443 DE

Reactions reported

Event ID CASEID DRUG REC ACT PT
124784434 12478443 Acute pulmonary oedema
124784434 12478443 Arrhythmia
124784434 12478443 Atelectasis
124784434 12478443 Atrial fibrillation
124784434 12478443 Blood albumin decreased
124784434 12478443 Blood calcium decreased
124784434 12478443 Blood chloride decreased
124784434 12478443 Blood magnesium increased
124784434 12478443 Blood phosphorus increased
124784434 12478443 Blood urea increased
124784434 12478443 Cardiac arrest
124784434 12478443 Delirium
124784434 12478443 Fall
124784434 12478443 Febrile neutropenia
124784434 12478443 Glomerular filtration rate decreased
124784434 12478443 Mucosal inflammation
124784434 12478443 Myocardial infarction
124784434 12478443 Pleural effusion
124784434 12478443 Pulmonary congestion
124784434 12478443 Tendon rupture

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
124784434 12478443 1 20160611 20160619 0
124784434 12478443 2 20160611 20160611 0
124784434 12478443 3 20160611 20160611 0
124784434 12478443 4 20160611 20160611 0
124784434 12478443 5 20160611 20160611 0