Study: NCT01684215

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 5 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: General physical health deterioration
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Femur fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Genital haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 5 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Anal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 3 affected / 6 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Cancer pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Gastrointestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 6 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 6 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 6 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 6 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Glossitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Parosmia
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Sensory disturbance
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Anxiety disorder
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Calculus urinary
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 6 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Dermal cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Haemorrhage subcutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 6 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 10 affected / 42 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 12 affected / 42 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 9 affected / 42 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 32 affected / 42 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 5 affected / 42 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 9 affected / 42 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 19 affected / 42 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 6 affected / 42 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 9 affected / 42 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 12 affected / 42 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 11 affected / 42 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 34 affected / 42 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 9 affected / 42 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 5 affected / 42 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 30 affected / 42 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 6 affected / 42 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 42 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 7 affected / 42 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 6 affected / 42 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 42 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 8 affected / 42 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 42 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 8 affected / 42 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 5 affected / 42 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 5 affected / 42 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 9 affected / 42 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 5 affected / 42 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 5 affected / 42 at risk

Adverse event: Angular cheilitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 42 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 42 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 42 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 3 affected / 42 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 8 affected / 42 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 42 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 3 affected / 42 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 3 affected / 42 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 42 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 42 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 5 affected / 42 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 3 affected / 42 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 3 affected / 42 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 3 affected / 42 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 5 affected / 42 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 3 affected / 42 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 42 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 3 affected / 42 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 3 affected / 42 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 3 affected / 42 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 4 affected / 42 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 3 affected / 42 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 42 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Glossitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 42 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 42 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 42 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Sensory disturbance
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 42 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Dermal cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Haemorrhage subcutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 42 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 3 affected / 42 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 42 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 2 affected / 42 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk

Adverse event: Cancer pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v17.1 was used for Dose Escalation Cohorts. MedDRA v20.1 was used for MTD Cohort. MedDRA v21.1 was used for Expanded Cohort.
Frequency: 1 affected / 42 at risk