Study: NCT03938857

Adverse event: Bladder and urethral symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Febrile disorders
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Heart rate and pulse investigations
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Laryngeal spasm, oedema and obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Parainfluenzae viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Rate and rhythm disorders NEC
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 6 at risk

Adverse event: Vascular hypotensive disorders
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 6 at risk

Adverse event: General signs and symptoms NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Colitis (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Anaesthetic and allied procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 12 at risk

Adverse event: Anxiety symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 12 at risk

Adverse event: Bladder and urethral symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 12 at risk

Adverse event: Colitis (excl infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Conditions associated with abnormal gas exchange
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Encephalopathies NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: General signs and symptoms NEC
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hepatic failure and associated disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Magnesium metabolism disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pneumothorax and pleural effusions NEC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Protein metabolism disorders NEC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Rate and rhythm disorders NEC
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 12 at risk

Adverse event: Renal failure and impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 12 at risk

Adverse event: Respiratory tract and thoracic cavity procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 12 at risk

Adverse event: Vascular hypotensive disorders
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 12 at risk

Adverse event: Seizures and seizure disorder NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Bladder and urethral symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Febrile disorders
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nausea and vomiting symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pneumothorax and pleural effusions NEC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Rate and rhythm disorders NEC
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 12 at risk

Adverse event: Seizures and seizure disorders NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Stereotypies and automatisms
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 12 at risk

Adverse event: Tremor (excl congenital)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Vascular hypotensive disorders
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 12 at risk