Study: NCT02083380

Adverse event: Hemoglobin drop < 5 g/dL
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 146 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 146 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 146 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 146 at risk

Adverse event: Plasmodium falciparum infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 146 at risk

Adverse event: Electrocardiumgram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 44 affected / 146 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 146 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 146 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 146 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 146 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 146 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 146 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 148 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 148 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 148 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 148 at risk

Adverse event: Plasmodium falciparum infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 148 at risk

Adverse event: Electrocardiumgram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 41 affected / 148 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 148 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 148 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 148 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 148 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 148 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 148 at risk

Adverse event: Transaminase elevation
Serious: yes
Organ System: Investigations
Notes: Two reversible SAEs of possibly related reversible transaminase elevation in one subject
Frequency: 1 affected / 143 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 143 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 143 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 143 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 143 at risk

Adverse event: Plasmodium falciparum infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 143 at risk

Adverse event: Electrocardiumgram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 27 affected / 143 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 143 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 143 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 143 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 143 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 143 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 143 at risk