Study: NCT02649946

Adverse event: Blood and lymphatic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 142 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 31 affected / 142 at risk

Adverse event: Eye disorders
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 142 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 142 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 19 affected / 142 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 47 affected / 142 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 37 affected / 142 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 142 at risk

Adverse event: Metabolism and nutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 142 at risk

Adverse event: Muskuloskeletal and connective disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 142 at risk

Adverse event: Neoplasms benign, malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 142 at risk

Adverse event: Nervous system
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 142 at risk

Adverse event: Psychiatric
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 142 at risk

Adverse event: Renal and urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 142 at risk

Adverse event: Respiratory, thoracic and mediastinal
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 142 at risk

Adverse event: Skin and subcutaneous tissue
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 142 at risk

Adverse event: Vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 25 affected / 142 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 142 at risk

Adverse event: Blood and lymphatic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 142 at risk

Adverse event: Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 39 affected / 142 at risk

Adverse event: Ear and labyrinth
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 142 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 142 at risk

Adverse event: Eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 142 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 142 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Frequency: 25 affected / 142 at risk

Adverse event: Hepatobiliary
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 142 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 60 affected / 142 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 56 affected / 142 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Electrocardiogram ST segment depression, liver function, abnormal and test abnormal, peritoneal effluent and troponin T increase.
Frequency: 4 affected / 142 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 142 at risk

Adverse event: Muskuloskeletal and connective tissues
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 142 at risk

Adverse event: Neoplasm benign, malignant and unspecified
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 142 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 142 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 142 at risk

Adverse event: Renal and urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 142 at risk

Adverse event: Reproductive system and breast
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 142 at risk

Adverse event: Respiratory, thoracic and mediastinal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 142 at risk

Adverse event: Skin and subcutaneous tissue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 142 at risk

Adverse event: Vascular
Serious: no
Organ System: Vascular disorders
Frequency: 37 affected / 142 at risk

Adverse event: Blood and lymphatic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 138 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 40 affected / 138 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 138 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 138 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 37 affected / 138 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 34 affected / 138 at risk

Adverse event: Metabolism and nutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 138 at risk

Adverse event: Muskuloskeletal and connective disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Neoplasms benign, malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 138 at risk

Adverse event: Nervous system
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 138 at risk

Adverse event: Psychiatric
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 138 at risk

Adverse event: Renal and urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 14 affected / 138 at risk

Adverse event: Respiratory, thoracic and mediastinal
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 138 at risk

Adverse event: Skin and subcutaneous tissue
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 138 at risk

Adverse event: Vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 24 affected / 138 at risk

Adverse event: Blood and lymphatic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 138 at risk

Adverse event: Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 44 affected / 138 at risk

Adverse event: Ear and labyrinth
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 138 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 138 at risk

Adverse event: Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 138 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 138 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Frequency: 15 affected / 138 at risk

Adverse event: Hepatobiliary
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 138 at risk

Adverse event: Immune system
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 138 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 138 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 45 affected / 138 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Electrocardiogram ST segment depression, liver function, abnormal and test abnormal, peritoneal effluent and troponin T increase.
Frequency: 4 affected / 138 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 138 at risk

Adverse event: Muskuloskeletal and connective tissues
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 138 at risk

Adverse event: Neoplasm benign, malignant and unspecified
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 138 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 138 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 138 at risk

Adverse event: Renal and urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 138 at risk

Adverse event: Respiratory, thoracic and mediastinal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 138 at risk

Adverse event: Skin and subcutaneous tissue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 138 at risk

Adverse event: Vascular
Serious: no
Organ System: Vascular disorders
Frequency: 35 affected / 138 at risk