Study: NCT03015259

Adverse event: Cerebrospinal fluid leakage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 613 at risk

Adverse event: Staphylococcal skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 613 at risk

Adverse event: Alcoholic pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 613 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 613 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 613 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 613 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 613 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 613 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 613 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 613 at risk

Adverse event: gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 613 at risk

Adverse event: injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 613 at risk

Adverse event: nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 613 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 613 at risk

Adverse event: infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 54 affected / 613 at risk

Adverse event: respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 613 at risk

Adverse event: musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 613 at risk

Adverse event: investigations
Serious: no
Organ System: Investigations
Frequency: 2 affected / 613 at risk

Adverse event: general disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 5 affected / 613 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 613 at risk

Adverse event: metabolism and nutrition disorders
Serious: no
Organ System: Investigations
Frequency: 4 affected / 613 at risk

Adverse event: skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 613 at risk

Adverse event: cardia disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 613 at risk

Adverse event: immune system disorders
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 613 at risk

Adverse event: psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 613 at risk

Adverse event: vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 613 at risk

Adverse event: ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 613 at risk

Adverse event: eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 613 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 622 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 622 at risk

Adverse event: Head injurt
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 622 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 622 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 622 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 622 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 622 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 622 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 622 at risk

Adverse event: gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 622 at risk

Adverse event: injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 622 at risk

Adverse event: nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 622 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 622 at risk

Adverse event: infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 622 at risk

Adverse event: respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 48 affected / 622 at risk

Adverse event: musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 622 at risk

Adverse event: investigations
Serious: no
Organ System: Investigations
Frequency: 7 affected / 622 at risk

Adverse event: general disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 4 affected / 622 at risk

Adverse event: metabolism and nutrition disorders
Serious: no
Organ System: Investigations
Frequency: 6 affected / 622 at risk

Adverse event: skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 622 at risk

Adverse event: cardia disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 622 at risk

Adverse event: psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 622 at risk

Adverse event: vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 622 at risk

Adverse event: eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 622 at risk

Adverse event: pregnancy, puerperium, and perinatal conditions
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 622 at risk

Adverse event: renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 622 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 204 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 204 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 204 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 204 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 204 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 204 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 39 affected / 204 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 204 at risk

Adverse event: gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 204 at risk

Adverse event: injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 204 at risk

Adverse event: nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 204 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 204 at risk

Adverse event: infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 204 at risk

Adverse event: respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 48 affected / 204 at risk

Adverse event: musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 204 at risk

Adverse event: investigations
Serious: no
Organ System: Investigations
Frequency: 3 affected / 204 at risk

Adverse event: general disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 2 affected / 204 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 204 at risk

Adverse event: metabolism and nutrition disorders
Serious: no
Organ System: Investigations
Frequency: 1 affected / 204 at risk

Adverse event: skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 204 at risk

Adverse event: cardia disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 204 at risk

Adverse event: immune system disorders
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 204 at risk

Adverse event: psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 204 at risk

Adverse event: vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 204 at risk