Study: NCT04632706

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: 2 subjects on active treatment experienced 3 AEs; 2 AEs (one in each subject) were possibly related to study drug
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject on active treatment experienced 1 AE; it was possibly related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 subjects on active treatment experienced 4 AEs and 1 subject on placebo experienced 1 AE; 1 AE in the treatment group was possibly related to the study drug
Frequency: 3 affected / 6 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: 2 subjects on active treatment experienced 2 AEs and 1 subject on placebo experienced 1 AE; for 1 subject on active treatment and 1 subject on placebo it was possibly related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 4 subjects on active treatment experienced 6 AEs and one subject on placebo experienced 1 AE; none were related to the study drug
Frequency: 3 affected / 6 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Notes: 1 subject on active treatment experienced 1 AE and 2 subjects on placebo experienced 2 AEs; none were related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: 2 subjects on active treatment experienced 2 AEs; they were not related to the study drug
Frequency: 2 affected / 6 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 2 subjects on active treatment experienced 2 AEs; they were not related to the study drug
Frequency: 2 affected / 6 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 2 subjects on active treatment experienced 2 AEs and 1 subject on placebo experienced 1 AE; none were related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: 2 subjects on active treatment experienced 3 AEs; 2 AEs (one in each subject) were possibly related to study drug
Frequency: 1 affected / 6 at risk

Adverse event: Back injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: 2 subjects on active treatment experienced 2 AEs and 1 subject on placebo experienced 1 AE; for 1 subject on active treatment and 1 subject on placebo it was possibly related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 2 subjects on active treatment experienced 2 AEs and 1 subject on placebo experienced 1 AE; none were related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 4 subjects on active treatment experienced 6 AEs and one subject on placebo experienced 1 AE; none were related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 subject on active treatment experienced 1 AE; it was unlikely related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 subjects on active treatment experienced 4 AEs and 1 subject on placebo experienced 1 AE; 1 AE in the treatment group was possibly related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 6 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Notes: 1 subject on placebo experienced 2 AEs
Frequency: 1 affected / 6 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 6 at risk

Adverse event: Burns first degree
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 6 at risk

Adverse event: Exposure to communicable disease
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 6 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 6 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 6 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 6 at risk

Adverse event: Muscle twitching
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 6 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: 2 subjects on active treatment experienced 2 AEs and 1 subject on placebo experienced 1 AE; for 1 subject on active treatment and 1 subject on placebo it was possibly related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 4 subjects on active treatment experienced 6 AEs and one subject on placebo experienced 1 AE; none were related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Notes: 1 subject on active treatment experienced 1 AE and 2 subjects on placebo experienced 2 AEs; none were related to the study drug
Frequency: 2 affected / 6 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 2 subjects on placebo experienced 2 AEs
Frequency: 2 affected / 6 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 6 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 2 subjects on active treatment experienced 2 AEs and 1 subject on placebo experienced 1 AE; none were related to the study drug
Frequency: 1 affected / 6 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: 2 subjects on active treatment experienced 3 AEs; 2 AEs (one in each subject) were possibly related to study drug
Frequency: 2 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject on active treatment experienced 1 AE; it was possibly related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 subjects on active treatment experienced 4 AEs and 1 subject on placebo experienced 1 AE; 1 AE in the treatment group was possibly related to the study drug
Frequency: 3 affected / 18 at risk

Adverse event: Back injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: 2 subjects on active treatment experienced 2 AEs and 1 subject on placebo experienced 1 AE; for 1 subject on active treatment and 1 subject on placebo it was possibly related to the study drug
Frequency: 2 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 4 subjects on active treatment experienced 6 AEs and one subject on placebo experienced 1 AE; none were related to the study drug
Frequency: 4 affected / 18 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Notes: 1 subject on active treatment experienced 1 AE and 2 subjects on placebo experienced 2 AEs; none were related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: 2 subjects on active treatment experienced 2 AEs; they were not related to the study drug
Frequency: 2 affected / 18 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 subject on active treatment experienced 1 AE; it was unlikely related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 2 subjects on active treatment experienced 2 AEs; they were not related to the study drug
Frequency: 2 affected / 18 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 2 subjects on active treatment experienced 2 AEs and 1 subject on placebo experienced 1 AE; none were related to the study drug
Frequency: 2 affected / 18 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: 2 subjects on active treatment experienced 3 AEs; 2 AEs (one in each subject) were possibly related to study drug
Frequency: 2 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject on active treatment experienced 1 AE; it was possibly related to the study drug
Frequency: 1 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 subjects on active treatment experienced 4 AEs and 1 subject on placebo experienced 1 AE; 1 AE in the treatment group was possibly related to the study drug
Frequency: 4 affected / 24 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 24 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Notes: 1 subject on placebo experienced 2 AEs
Frequency: 1 affected / 24 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 24 at risk

Adverse event: Back injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 24 at risk

Adverse event: Burns first degree
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 24 at risk

Adverse event: Exposure to communicable disease
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 24 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 24 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 24 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 24 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 24 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 24 at risk

Adverse event: Muscle twitching
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 24 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 24 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 24 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: 2 subjects on active treatment experienced 2 AEs and 1 subject on placebo experienced 1 AE; for 1 subject on active treatment and 1 subject on placebo it was possibly related to the study drug
Frequency: 3 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 4 subjects on active treatment experienced 6 AEs and one subject on placebo experienced 1 AE; none were related to the study drug
Frequency: 5 affected / 24 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Notes: 1 subject on active treatment experienced 1 AE and 2 subjects on placebo experienced 2 AEs; none were related to the study drug
Frequency: 3 affected / 24 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 24 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: 2 subjects on active treatment experienced 2 AEs; they were not related to the study drug
Frequency: 2 affected / 24 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 subject on active treatment experienced 1 AE; it was unlikely related to the study drug
Frequency: 1 affected / 24 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 2 subjects on placebo experienced 2 AEs
Frequency: 2 affected / 24 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 24 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 2 subjects on active treatment experienced 2 AEs; they were not related to the study drug
Frequency: 2 affected / 24 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 24 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 subject on placebo experienced 1 AE
Frequency: 1 affected / 24 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 subject on active treatment experienced 1 AE; it was not related to the study drug
Frequency: 1 affected / 24 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 2 subjects on active treatment experienced 2 AEs and 1 subject on placebo experienced 1 AE; none were related to the study drug
Frequency: 3 affected / 24 at risk