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
96937404 9693740 4 F 20160622 20131118 20160707 EXP IT-CELGENEUS-083-50794-13110739 CELGENE TERESA VOSO M, GIUSEPPE L, PICIOCCHI A, FIANCHI L, DI BARTOLOMEO P, CANDONI A. FEASIBILILTY OF AZACITIDINE AS BRIDGE TO ALLOGENEIC STEM CELL TRANSPLANTATION IN PATIENTS WITH HIGHER-RISK MDS OR LOW-BLAST COUNT AML: RESULTS OF THE BMT-AZA MULTICENTER PROSPECTIVE STUDY. 2015;. 0.00 Y 0.00000 20160707 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
96937404 9693740 1 PS VIDAZA AZACITIDINE 1 Subcutaneous U 50794 INJECTION

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
96937404 9693740 1 Myelodysplastic syndrome

Outcome of event

Event ID CASEID OUTC COD
96937404 9693740 DE
96937404 9693740 LT
96937404 9693740 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
96937404 9693740 Abdominal pain
96937404 9693740 Acute kidney injury
96937404 9693740 Anaemia
96937404 9693740 Anaemia of malignant disease
96937404 9693740 Aneurysm
96937404 9693740 Angina pectoris
96937404 9693740 Anorectal infection
96937404 9693740 Arthropathy
96937404 9693740 Blood disorder
96937404 9693740 Bronchitis
96937404 9693740 Bronchopulmonary aspergillosis
96937404 9693740 Bursitis
96937404 9693740 Cardiac arrest
96937404 9693740 Complications of transplant surgery
96937404 9693740 Constipation
96937404 9693740 Deafness
96937404 9693740 Death
96937404 9693740 Dehydration
96937404 9693740 Diarrhoea
96937404 9693740 Endocarditis
96937404 9693740 Erythema
96937404 9693740 Face oedema
96937404 9693740 Fatigue
96937404 9693740 Febrile neutropenia
96937404 9693740 Gastroenteritis
96937404 9693740 Gastrointestinal disorder
96937404 9693740 Graft versus host disease
96937404 9693740 Graft versus host disease in skin
96937404 9693740 Haematuria
96937404 9693740 Haemorrhage intracranial
96937404 9693740 Hepatic failure
96937404 9693740 Hepatic infection
96937404 9693740 Herpes zoster
96937404 9693740 Infection
96937404 9693740 Interstitial lung disease
96937404 9693740 Intra-abdominal haemorrhage
96937404 9693740 Laryngeal pain
96937404 9693740 Lower respiratory tract infection
96937404 9693740 Lung disorder
96937404 9693740 Lung infection
96937404 9693740 Middle ear inflammation
96937404 9693740 Multiple organ dysfunction syndrome
96937404 9693740 Musculoskeletal disorder
96937404 9693740 Myelodysplastic syndrome
96937404 9693740 Nasopharyngitis
96937404 9693740 Nausea
96937404 9693740 Neoplasm
96937404 9693740 Neutropenia
96937404 9693740 Pharyngeal disorder
96937404 9693740 Pharyngitis
96937404 9693740 Pneumonia
96937404 9693740 Pyrexia
96937404 9693740 Respiratory failure
96937404 9693740 Sepsis
96937404 9693740 Septic shock
96937404 9693740 Sialoadenitis
96937404 9693740 Swelling
96937404 9693740 Thrombocytopenia
96937404 9693740 Thrombocytopenic purpura
96937404 9693740 Toxoplasmosis
96937404 9693740 Urinary tract infection
96937404 9693740 Urticaria
96937404 9693740 Weight decreased
96937404 9693740 White blood cell count decreased

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

no results found

Therapies reported

no results found