Study: NCT02619682

Adverse event: pneumonia with sepsis
Serious: yes
Organ System: Infections and infestations
Notes: hospitalization
Frequency: 1 affected / 30 at risk

Adverse event: Pneumonia without sepsis
Serious: yes
Organ System: Infections and infestations
Notes: hospitalization
Frequency: 1 affected / 30 at risk

Adverse event: RSV Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: hospitalization
Frequency: 1 affected / 30 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Notes: hospitalization
Frequency: 1 affected / 30 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Notes: grade 2
Frequency: 2 affected / 30 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Notes: grade 2
Frequency: 1 affected / 30 at risk

Adverse event: lymphocyte decreased
Serious: no
Organ System: Investigations
Notes: grade 2
Frequency: 11 affected / 30 at risk

Adverse event: lymphocyte decreased
Serious: no
Organ System: Investigations
Notes: grade 3
Frequency: 10 affected / 30 at risk

Adverse event: phosphorus decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: grade 2
Frequency: 5 affected / 30 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: grade 2
Frequency: 4 affected / 30 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: grade 2
Frequency: 10 affected / 30 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: grade 3
Frequency: 6 affected / 30 at risk

Adverse event: Platelet decreased
Serious: no
Organ System: Investigations
Notes: grade 2
Frequency: 7 affected / 30 at risk

Adverse event: Platelet decreased
Serious: no
Organ System: Investigations
Notes: grade 3
Frequency: 2 affected / 30 at risk

Adverse event: Platelet decreased
Serious: no
Organ System: Investigations
Notes: grade 4
Frequency: 1 affected / 30 at risk

Adverse event: ANC decreased
Serious: no
Organ System: Investigations
Notes: grade 2
Frequency: 9 affected / 30 at risk

Adverse event: ANC decreased
Serious: no
Organ System: Investigations
Notes: grade 3
Frequency: 7 affected / 30 at risk

Adverse event: ANC decreased
Serious: no
Organ System: Investigations
Notes: grade 4
Frequency: 2 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: grade 3
Frequency: 2 affected / 30 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: grade 2
Frequency: 3 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 2
Frequency: 1 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 2
Frequency: 1 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 3
Frequency: 2 affected / 30 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 2
Frequency: 4 affected / 30 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: grade 2
Frequency: 1 affected / 30 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: grade 2
Frequency: 2 affected / 30 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: grade 2
Frequency: 1 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 2
Frequency: 1 affected / 30 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 2
Frequency: 1 affected / 30 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: grade 2
Frequency: 1 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: grade 2
Frequency: 1 affected / 30 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: grade 2
Frequency: 1 affected / 30 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: grade 3
Frequency: 1 affected / 30 at risk

Adverse event: giardia gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Notes: grade 2
Frequency: 1 affected / 30 at risk

Adverse event: superficial vein blood clot
Serious: no
Organ System: Vascular disorders
Notes: grade 2
Frequency: 1 affected / 30 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: grade 2
Frequency: 2 affected / 30 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Notes: grade 2
Frequency: 1 affected / 30 at risk

Adverse event: Zoster
Serious: no
Organ System: Infections and infestations
Notes: grade 2
Frequency: 1 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: grade 2
Frequency: 1 affected / 30 at risk