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
127398391 12739839 1 I 20160826 0 20160910 20160910 DIR FDA-CTU 11.90 YR F N 127.10000 KG 20160909 N MD US US

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
127398391 12739839 1 PS ONCASPAR PEGASPARGASE 1 D D 0 4027.5 MG
127398391 12739839 2 SS CYTARABINE. CYTARABINE 1 0 70 MG
127398391 12739839 3 SS DAUNORUBICIN DAUNORUBICIN 1 0 160 MG
127398391 12739839 4 SS METHOTREXATE. METHOTREXATE 1 0 15 MG
127398391 12739839 5 SS PREDNISONE. PREDNISONE 1 0 1710 MG

Indications of drugs used

no results found

Outcome of event

Event ID CASEID OUTC COD
127398391 12739839 DE
127398391 12739839 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
127398391 12739839 Acute kidney injury
127398391 12739839 Bacteraemia
127398391 12739839 Bacteroides test positive
127398391 12739839 Cardio-respiratory arrest
127398391 12739839 Coagulopathy
127398391 12739839 Colitis
127398391 12739839 Condition aggravated
127398391 12739839 Disseminated intravascular coagulation
127398391 12739839 Dysarthria
127398391 12739839 Enterococcus test positive
127398391 12739839 Fatigue
127398391 12739839 Fungaemia
127398391 12739839 Glucose tolerance impaired
127398391 12739839 Hepatic function abnormal
127398391 12739839 Hepatomegaly
127398391 12739839 Hypoglycaemia
127398391 12739839 Hypotension
127398391 12739839 Incoherent
127398391 12739839 Jaundice
127398391 12739839 Kussmaul respiration
127398391 12739839 Lactic acidosis
127398391 12739839 Mental status changes
127398391 12739839 Metabolic acidosis
127398391 12739839 Nausea
127398391 12739839 Neutropenia
127398391 12739839 Pulmonary haemorrhage
127398391 12739839 Sepsis
127398391 12739839 Thrombocytopenia
127398391 12739839 Vomiting

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

Event ID CASEID RPSR COD
127398391 12739839 HP

Therapies reported

Event ID CASEID DSG DRUG SEQ START DT END DT DUR DUR COD
127398391 12739839 1 20160828 0
127398391 12739839 2 20160801 0
127398391 12739839 3 20160824 0
127398391 12739839 4 20160810 0
127398391 12739839 5 20160828 0