Study: NCT04828707

Adverse event: SAE - suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant with stress/anxiety disorder tried to commit suicide during the treatment phase. The participant was hospitalized following the event and discontinued the study
Frequency: 1 affected / 128 at risk

Adverse event: SAE - falling in bathroom
Serious: yes
Organ System: Surgical and medical procedures
Notes: The participant falls in the bathroom and hit his head on the sink. participant required medical treatment and decide to discontinue the study.
Frequency: 1 affected / 128 at risk

Adverse event: COVID 19
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 128 at risk

Adverse event: Sinusitis/common cold
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 128 at risk

Adverse event: Bruises from falling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 128 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 128 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 128 at risk

Adverse event: Migraine/headache worsening
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 128 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 128 at risk

Adverse event: nfluenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 128 at risk

Adverse event: Dental Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 128 at risk

Adverse event: Lipoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 128 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 128 at risk

Adverse event: Hornet Stings
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 128 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 128 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 128 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 128 at risk

Adverse event: COVID 19
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 120 at risk

Adverse event: Sinusitis/common cold
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 120 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 120 at risk

Adverse event: Migraine/headache worsening
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 120 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: nfluenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Worsening of fibromyalgia pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: worsening of chronic rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 120 at risk

Adverse event: cervical precancerous cells diagnosis
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 120 at risk

Adverse event: Ankle fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Worsening of Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 120 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 120 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Overweight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 120 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk