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
125992533 12599253 3 F 20160808 20160727 20160818 EXP IT-ROCHE-1800888 ROCHE SORA F, CHIUSOLO P, LAURENTI L, AUTORE F, GIAMMARCO S AND SICA S. MASSIVE PULMONARY EMBOLISM AT THE ONSET OF ACUTE PROMYELOCYTIC LEUKEMIA. . MEDITERRANEAN JOURNAL OF HEMATOLOGY AND INFECTIOUS DISEASES 2016 JUL 01;8 (1):E2016027-. 24.00 YR F Y 0.00000 20160818 MD 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
125992533 12599253 1 PS Actilyse ALTEPLASE 1 Unknown OVER 2 H 103172 100 MG
125992533 12599253 2 SS TRETINOIN. TRETINOIN 1 Oral Y 0 22.5 MG/M**2 CAPSULE BID
125992533 12599253 3 SS HEPARIN SODIUM. HEPARIN SODIUM 1 Intravenous (not otherwise specified) U 0
125992533 12599253 4 SS METHYLPREDNISOLON METHYLPREDNISOLONE 1 Unknown U 0 .5 MG/KG
125992533 12599253 5 SS ARSENIC TRIOXIDE ARSENIC TRIOXIDE 1 Unknown 0
125992533 12599253 6 SS DEXAMETHASONE. DEXAMETHASONE 1 Unknown 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125992533 12599253 1 Pulmonary embolism
125992533 12599253 2 Acute promyelocytic leukaemia
125992533 12599253 3 Pulmonary embolism
125992533 12599253 4 Acute promyelocytic leukaemia differentiation syndrome
125992533 12599253 5 Acute promyelocytic leukaemia
125992533 12599253 6 Acute promyelocytic leukaemia differentiation syndrome

Outcome of event

Event ID CASEID OUTC COD
125992533 12599253 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
125992533 12599253 Acute promyelocytic leukaemia differentiation syndrome
125992533 12599253 Asthenia
125992533 12599253 Chest pain
125992533 12599253 Electrocardiogram T wave abnormal
125992533 12599253 Hypotension
125992533 12599253 Hypoxia
125992533 12599253 Leukocytosis
125992533 12599253 Tachypnoea
125992533 12599253 Troponin increased

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

no results found

Therapies reported

no results found