Study: NCT02467842

Adverse event: Nasal septum deviation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Mild Severity, recovered, unrelated to NBP607-QIV
Frequency: 1 affected / 752 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 752 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 752 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 752 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 752 at risk

Adverse event: Benign breast neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 752 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 752 at risk

Adverse event: Acute abdomen
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 752 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 752 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 207 affected / 752 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 198 affected / 752 at risk

Adverse event: Redness/erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 44 affected / 752 at risk

Adverse event: Induration/swelling
Serious: no
Organ System: General disorders
Frequency: 14 affected / 752 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 130 affected / 752 at risk

Adverse event: Fatigue/Malaise
Serious: no
Organ System: General disorders
Frequency: 101 affected / 752 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 71 affected / 752 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 752 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 752 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 752 at risk

Adverse event: Gastric ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 373 at risk

Adverse event: Otitis externa
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 373 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 373 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 84 affected / 373 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 70 affected / 373 at risk

Adverse event: Redness/erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 373 at risk

Adverse event: Induration/swelling
Serious: no
Organ System: General disorders
Frequency: 8 affected / 373 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 58 affected / 373 at risk

Adverse event: Fatigue/Malaise
Serious: no
Organ System: General disorders
Frequency: 71 affected / 373 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 373 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 373 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 373 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 373 at risk

Adverse event: Colon operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 378 at risk

Adverse event: Prostatic specific antigen increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 378 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 378 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 378 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 81 affected / 378 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 71 affected / 378 at risk

Adverse event: Redness/erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 378 at risk

Adverse event: Induration/swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 378 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 55 affected / 378 at risk

Adverse event: Fatigue/Malaise
Serious: no
Organ System: General disorders
Frequency: 60 affected / 378 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 378 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 378 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 378 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 378 at risk