Study: NCT02027376

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 2 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 3 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 4 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 3 affected / 5 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 5 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 2 affected / 5 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 2 affected / 5 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1
Frequency: 2 affected / 5 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1
Frequency: 2 affected / 5 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 5 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 1 affected / 5 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 2 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 5 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 5 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Grade 1
Frequency: 1 affected / 5 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1
Frequency: 1 affected / 5 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Overdose of grade 1. This patient took 800mg once instead of 600mg (only took one additional tablet) during cycle 3 at DL 2. No any additional AEs were observed due to this intake of a higher dose of sonidegib.
Frequency: 1 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 2 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 1 affected / 4 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Grade 4
Frequency: 1 affected / 4 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 2 affected / 4 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 4 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 4 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 4 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Creatine Phosphokinase (CPK) increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 2 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 3 affected / 3 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 2 affected / 3 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1
Frequency: 2 affected / 3 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1
Frequency: 2 affected / 3 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 2 affected / 3 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 3 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 2 affected / 3 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 3 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 2 affected / 3 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 3 at risk

Adverse event: Creatine Phosphokinase (CPK) increased
Serious: no
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Notes: Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Eyelid function disorder
Serious: no
Organ System: Eye disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk