Study: NCT04092387

Adverse event: Psychiatric disorders - Other
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 83 at risk

Adverse event: Oesophageal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Irritability
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 83 at risk

Adverse event: Tumour pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 83 at risk

Adverse event: Pregnancy, puerperium and perinatal conditions
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 83 at risk

Adverse event: Surgical and medical procedures - Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 83 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 83 at risk

Adverse event: OASIS Score Increase
Serious: no
Organ System: Psychiatric disorders
Frequency: 32 affected / 83 at risk

Adverse event: BDI Category Increase
Serious: no
Organ System: Psychiatric disorders
Frequency: 29 affected / 83 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 27 affected / 83 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 83 at risk

Adverse event: General disorders and administration
Serious: no
Organ System: General disorders
Frequency: 18 affected / 83 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 83 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 83 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 83 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 83 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 83 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 83 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 83 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 83 at risk

Adverse event: Surgical and medical procedures - Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 85 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 85 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 85 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 85 at risk

Adverse event: OASIS Score Increase
Serious: no
Organ System: Psychiatric disorders
Frequency: 31 affected / 85 at risk

Adverse event: BDI Category Increase
Serious: no
Organ System: Psychiatric disorders
Frequency: 29 affected / 85 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 28 affected / 85 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 85 at risk

Adverse event: General disorders and administration
Serious: no
Organ System: General disorders
Frequency: 24 affected / 85 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 85 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 85 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 85 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 85 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 85 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 85 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 85 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 85 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 74 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 74 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 74 at risk

Adverse event: OASIS Score Increase
Serious: no
Organ System: Psychiatric disorders
Frequency: 31 affected / 74 at risk

Adverse event: BDI Category Increase
Serious: no
Organ System: Psychiatric disorders
Frequency: 26 affected / 74 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 74 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 74 at risk

Adverse event: General disorders and administration
Serious: no
Organ System: General disorders
Frequency: 16 affected / 74 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 74 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 74 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 74 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 74 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 74 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 74 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 74 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 74 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 84 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: OASIS Score Increase
Serious: no
Organ System: Psychiatric disorders
Frequency: 31 affected / 84 at risk

Adverse event: BDI Category Increase
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 84 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 24 affected / 84 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 84 at risk

Adverse event: General disorders and administration
Serious: no
Organ System: General disorders
Frequency: 22 affected / 84 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 84 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 84 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 84 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 84 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 84 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 84 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 84 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 84 at risk