Study: NCT02032433

Adverse event: Psychiatric
Serious: yes
Organ System: Psychiatric disorders
Frequency: 10 affected / 283 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 283 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 283 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 283 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 283 at risk

Adverse event: Respiratory, thoracic, and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 283 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 283 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 283 at risk

Adverse event: Eye disorders
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 283 at risk

Adverse event: Reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 283 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 283 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 29 affected / 283 at risk

Adverse event: Injury poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 283 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 283 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 283 at risk

Adverse event: General Disorders and Administration Site Conditions
Serious: no
Organ System: General disorders
Frequency: 10 affected / 283 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 283 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 10 affected / 283 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 283 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 283 at risk

Adverse event: Metabolism and nutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 283 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 283 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 283 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 283 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 283 at risk

Adverse event: Hepatbiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 283 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 283 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 283 at risk

Adverse event: Social circumstances
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 283 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 283 at risk

Adverse event: Psychiatric
Serious: yes
Organ System: Psychiatric disorders
Frequency: 12 affected / 287 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 287 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 270 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 270 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 270 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 270 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 270 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 270 at risk

Adverse event: Hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 270 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 287 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 287 at risk

Adverse event: Injury poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 22 affected / 287 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 287 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 287 at risk

Adverse event: General Disorders and Administration Site Conditions
Serious: no
Organ System: General disorders
Frequency: 21 affected / 287 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 287 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 11 affected / 287 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 287 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 287 at risk

Adverse event: Metabolism and nutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 287 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 287 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 287 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 287 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 287 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 287 at risk

Adverse event: Hepatbiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 287 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 287 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Product issues
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 287 at risk