Study: NCT01982812

Adverse event: Death
Serious: yes
Organ System: Nervous system disorders
Notes: Died with respiratory then cardiac failure as is typical of death in pediatric cerebral malaria
Frequency: 1 affected / 23 at risk

Adverse event: elevated AST
Serious: yes
Organ System: Hepatobiliary disorders
Notes: laboratory assessment at 24 hours, 7 days and 1 month post randomization
Frequency: 3 affected / 23 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Persistent or worsening thrombocytopenia
Frequency: 2 affected / 23 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Based upon creatinine
Frequency: 1 affected / 23 at risk

Adverse event: Myoclonus
Serious: no
Organ System: Nervous system disorders
Notes: myoclonic jerks while fully awake
Frequency: 1 affected / 23 at risk

Adverse event: Increased AST
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 23 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: elevated platelet count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Decreased reticulocyte count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Increased ALT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 23 at risk

Adverse event: Increased alkaline phosphotase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 23 at risk

Adverse event: Increased potassium
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 23 at risk

Adverse event: Increased chloride
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: increased phosphate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 23 at risk

Adverse event: increased calcium
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Death
Serious: yes
Organ System: Nervous system disorders
Notes: Died with respiratory then cardiac failure as is typical of death in pediatric cerebral malaria
Frequency: 5 affected / 21 at risk

Adverse event: elevated AST
Serious: yes
Organ System: Hepatobiliary disorders
Notes: laboratory assessment at 24 hours, 7 days and 1 month post randomization
Frequency: 2 affected / 21 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Persistent or worsening thrombocytopenia
Frequency: 1 affected / 21 at risk

Adverse event: respiratory suppression or aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Anemia with persistent low retics
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: At 30 days post d/c
Frequency: 1 affected / 21 at risk

Adverse event: Increased AST
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 21 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 21 at risk

Adverse event: elevated platelet count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Decreased reticulocyte count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 21 at risk

Adverse event: Electrocardiogram abnormal
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Excess sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Increased ALT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 21 at risk

Adverse event: Increased alkaline phosphotase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 21 at risk

Adverse event: Increased potassium
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 21 at risk

Adverse event: increased phosphate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk