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
127033901 12703390 1 I 20160824 20160831 20160831 EXP ES-JNJFOC-20160826011 JANSSEN GONZALEZ-BARCA E, CANALES M, SALAR A, FERRER S, DOMINGO-DOMENECH E, VIDAL M, ET AL. LONG-TERM FOLLOW-UP OF A PHASE II TRIAL OF SIX CYCLES OF DOSE-DENSE R-CHOP-14 FOR FIRST-LINE TREATMENT OF DIFFUSE LARGE B-CELL LYMPHOMA IN YOUNG AND ELDERLY PATIENTS.. ACTA HAEMATOLOGICA 2016;136 (2):76-84. 0.00 Y 0.00000 20160831 MD ES ES

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
127033901 12703390 1 PS DOXORIBICIN DOXORUBICIN 1 Unknown U 50718 50 MG/M**2 LIPOSOME INJECTION
127033901 12703390 2 SS RITUXIMAB RITUXIMAB 1 Unknown ON DAY 1 0 375 MG/M**2 UNSPECIFIED
127033901 12703390 3 SS VINCRISTINE VINCRISTINE 1 Unknown MAXIMAL DOSE 2 MG 0 1.4 MG/M**2 UNSPECIFIED
127033901 12703390 4 SS PREDNISONE. PREDNISONE 1 Unknown FOR 5 DAYS 0 100 MG UNSPECIFIED
127033901 12703390 5 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Unknown 0 750 MG/M**2 UNSPECIFIED

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127033901 12703390 1 Diffuse large B-cell lymphoma
127033901 12703390 2 Diffuse large B-cell lymphoma
127033901 12703390 3 Diffuse large B-cell lymphoma
127033901 12703390 4 Diffuse large B-cell lymphoma
127033901 12703390 5 Diffuse large B-cell lymphoma

Outcome of event

Event ID CASEID OUTC COD
127033901 12703390 OT
127033901 12703390 DE

Reactions reported

Event ID CASEID DRUG REC ACT PT
127033901 12703390 Alopecia
127033901 12703390 Anaemia
127033901 12703390 Asthenia
127033901 12703390 Bone pain
127033901 12703390 Constipation
127033901 12703390 Decreased appetite
127033901 12703390 Diarrhoea
127033901 12703390 Dyspnoea
127033901 12703390 Febrile neutropenia
127033901 12703390 Gastric haemorrhage
127033901 12703390 Mucosal inflammation
127033901 12703390 Neuropathy peripheral
127033901 12703390 Neutropenia
127033901 12703390 Oral candidiasis
127033901 12703390 Paraesthesia
127033901 12703390 Pneumonia
127033901 12703390 Pyrexia
127033901 12703390 Respiratory failure
127033901 12703390 Retching
127033901 12703390 Sepsis
127033901 12703390 Septic shock
127033901 12703390 Throat irritation
127033901 12703390 Treatment noncompliance
127033901 12703390 Vomiting

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

no results found