Study: NCT02944448

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Last Treatment Patient Received: CR845 5.0 mg
Frequency: 1 affected / 316 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Last Treatment Patient Received: CR845 2.5 mg
Frequency: 1 affected / 316 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Last Treatment Patient Received: CR845 1.0 mg
Frequency: 1 affected / 316 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Last Treatment Patient Received: CR845 5.0 mg; One patient experienced the serious adverse events of head injury, lumbar vertebral fracture, rib fracture, thoracic vertebral fracture, subdural haemorrhage and subarachnoid haemorhage.
Frequency: 1 affected / 316 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Last Treatment Patient Received: CR845 5.0 mg; One patient experienced the serious adverse events of head injury, lumbar vertebral fracture, rib fracture, thoracic vertebral fracture, subdural haemorrhage and subarachnoid haemorhage.
Frequency: 1 affected / 316 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Last Treatment Patient Received: CR845 5.0 mg; One patient experienced the serious adverse events of head injury, lumbar vertebral fracture, rib fracture, thoracic vertebral fracture, subdural haemorrhage and subarachnoid haemorhage.
Frequency: 1 affected / 316 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Last Treatment Patient Received: CR845 5.0 mg; One patient experienced the serious adverse events of head injury, lumbar vertebral fracture, rib fracture, thoracic vertebral fracture, subdural haemorrhage and subarachnoid haemorhage.
Frequency: 1 affected / 316 at risk

Adverse event: Thoracic vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Last Treatment Patient Received: CR845 5.0 mg; One patient experienced the serious adverse events of head injury, lumbar vertebral fracture, rib fracture, thoracic vertebral fracture, subdural haemorrhage and subarachnoid haemorhage.
Frequency: 1 affected / 316 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Last Treatment Patient Received: CR845 2.5 mg
Frequency: 1 affected / 316 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Last Treatment Patient Received: CR845 5.0 mg
Frequency: 1 affected / 316 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Last Treatment Patient Received: CR845 5.0 mg
Frequency: 1 affected / 316 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: Last Treatment Patient Received: CR845 5.0 mg; One patient experienced the serious adverse events of head injury, lumbar vertebral fracture, rib fracture, thoracic vertebral fracture, subdural haemorrhage and subarachnoid haemorhage.
Frequency: 1 affected / 316 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Notes: Last Treatment Patient Received: CR845 5.0 mg
Frequency: 1 affected / 316 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Last Treatment Patient Received: CR845 5.0 mg
Frequency: 1 affected / 316 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 316 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 316 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 316 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 316 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 160 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 160 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 160 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 160 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 160 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 160 at risk