Study: NCT02364609

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: includes grade 3-4 adverse events possibly, probably or definitely related to study drugs graded by CTCAEv4
Frequency: 1 affected / 6 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: includes grade 3-4 adverse events possibly, probably or definitely related to study drugs graded by CTCAEv4
Frequency: 1 affected / 6 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: includes grade 3-4 adverse events possibly, probably or definitely related to study drugs graded by CTCAEv4
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events occurring \>10% of patients.
Frequency: 5 affected / 6 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse events occurring \>10% of patients.
Frequency: 3 affected / 6 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Adverse events occurring \>10% of the patients
Frequency: 4 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 4 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 4 affected / 6 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Adverse events occurring \>10% of the patients
Frequency: 3 affected / 6 at risk

Adverse event: Anaemia
Serious: no
Organ System: Investigations
Notes: Adverse events occurring \>10% of the patients
Frequency: 5 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 4 affected / 6 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 3 affected / 6 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 3 affected / 6 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 3 affected / 6 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 2 affected / 6 at risk

Adverse event: Paronychia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 2 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 2 affected / 6 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 1 affected / 6 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 1 affected / 6 at risk

Adverse event: Elevated Liver Function tests
Serious: no
Organ System: Investigations
Notes: Adverse events occurring \>10% of the patients
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 2 affected / 6 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 5 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Grade4
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: includes grade 3-4 adverse events possibly, probably or definitely related to study drugs graded by CTCAEv4
Frequency: 1 affected / 5 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: includes grade 3-4 adverse events possibly, probably or definitely related to study drugs graded by CTCAEv4
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events occurring \>10% of patients.
Frequency: 4 affected / 5 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse events occurring \>10% of patients.
Frequency: 3 affected / 5 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Adverse events occurring \>10% of the patients
Frequency: 1 affected / 5 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 3 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 2 affected / 5 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Adverse events occurring \>10% of the patients
Frequency: 1 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Investigations
Notes: Adverse events occurring \>10% of the patients
Frequency: 3 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 5 affected / 5 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 1 affected / 5 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 1 affected / 5 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 2 affected / 5 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 2 affected / 5 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 1 affected / 5 at risk

Adverse event: Elevated Liver Function tests
Serious: no
Organ System: Investigations
Notes: Adverse events occurring \>10% of the patients
Frequency: 2 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events occurring \>10% of the patients
Frequency: 2 affected / 5 at risk