Study: NCT03290391

Adverse event: Tuberculosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 111 at risk

Adverse event: Death due to overdose
Serious: yes
Organ System: Social circumstances
Frequency: 3 affected / 111 at risk

Adverse event: Death due to heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 111 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 111 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 111 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 111 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 111 at risk

Adverse event: General weakness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 111 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 111 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Investigations
Frequency: 4 affected / 111 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 111 at risk

Adverse event: Wound infection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 111 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 111 at risk

Adverse event: COVID
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Death due to overdose
Serious: yes
Organ System: Social circumstances
Frequency: 2 affected / 114 at risk

Adverse event: Death due to heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 114 at risk

Adverse event: Death due to suicide
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 114 at risk

Adverse event: Death due to sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Death due to COVID
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 114 at risk

Adverse event: Death due to acute alcohol intoxication
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 114 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Pulmonary tuberculosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk