Study: NCT02222545

Adverse event: SAE by System Organ
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 28 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 28 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 28 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Immune system disorders
Frequency: 5 affected / 28 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 28 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 28 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 28 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Immune system disorders
Frequency: 10 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: General disorders
Frequency: 18 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Investigations
Frequency: 10 affected / 28 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 28 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 20 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 20 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 20 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 20 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 20 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Investigations
Frequency: 3 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Dysmenorrhoea
Frequency: 1 affected / 20 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Vertigo
Frequency: 1 affected / 20 at risk

Adverse event: SAE by System Organ
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 4 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 4 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: AE by System Organ
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk