Study: NCT01609010

Adverse event: General disorders and administration site conditions (ASC)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 156 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 156 at risk

Adverse event: Blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 156 at risk

Adverse event: Respiratory, thoracic and mediastinal (T&M) disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 156 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 156 at risk

Adverse event: Musculoskeletal and connective tissue (CT) disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 156 at risk

Adverse event: Immune system disorders
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 156 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 156 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 156 at risk

Adverse event: Neoplasms benign, malignant and unspecified (including cysts)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 156 at risk

Adverse event: General disorders and ASC
Serious: no
Organ System: General disorders
Frequency: 70 affected / 156 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 156 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 156 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 156 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 156 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 156 at risk

Adverse event: Respiratory, T&M disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 156 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 156 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 156 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Frequency: 15 affected / 156 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 156 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 156 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 6 affected / 156 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 156 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 156 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 156 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 156 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 156 at risk

Adverse event: Neoplasms benign, malignant and unspecified (including cysts)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 156 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 156 at risk

Adverse event: General disorders and administration site conditions (ASC)
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 157 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 157 at risk

Adverse event: Blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 157 at risk

Adverse event: Respiratory, thoracic and mediastinal (T&M) disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 157 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 157 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 157 at risk

Adverse event: Musculoskeletal and connective tissue (CT) disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 157 at risk

Adverse event: Immune system disorders
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 157 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 157 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 157 at risk

Adverse event: Injury, poisoning and procedural complications (PC)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 157 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 157 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 157 at risk

Adverse event: Ear and labyrinth disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 157 at risk

Adverse event: Eye disorders
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 157 at risk

Adverse event: General disorders and ASC
Serious: no
Organ System: General disorders
Frequency: 141 affected / 157 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 101 affected / 157 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 81 affected / 157 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 82 affected / 157 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 157 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 65 affected / 157 at risk

Adverse event: Respiratory, T&M disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 157 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 38 affected / 157 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 157 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Frequency: 18 affected / 157 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 157 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 157 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 14 affected / 157 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 157 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 157 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 157 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 157 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 157 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 157 at risk