Study: NCT00089284

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 7 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 7 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 7 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 7 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 3 affected / 7 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 7 at risk

Adverse event: Cytokine release syndrome (infusion reaction)
Serious: no
Organ System: Investigations
Notes: Attributed as related to study treatment.
Frequency: 2 affected / 7 at risk

Adverse event: Dermal change: skin discoloration
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Skin turned a green color. Attributed as related to study treatment.
Frequency: 4 affected / 7 at risk

Adverse event: Dermatology - Other: blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 7 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 7 at risk

Adverse event: FEV1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Attributed as probably related to study treatment.
Frequency: 4 affected / 7 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 4 affected / 7 at risk

Adverse event: Hemorrhage - gums
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 7 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 7 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 7 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 7 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 7 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 7 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 7 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 7 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Attributed as possibly related to study treatment.
Frequency: 4 affected / 7 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 7 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 7 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 7 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 7 at risk

Adverse event: Pain - chest/thorax not otherwise specified
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: Pain - headache
Serious: no
Organ System: Nervous system disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 7 at risk

Adverse event: Petechiae
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 7 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Transaminases - AST/ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 5 affected / 7 at risk

Adverse event: Urinary rentention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 7 at risk

Adverse event: Death - not otherwise specified
Serious: yes
Organ System: General disorders
Notes: Patient became deceased - no other information available.
Frequency: 1 affected / 3 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 3 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 3 at risk

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

Adverse event: Cytokine release syndrome (infusion reaction)
Serious: no
Organ System: Investigations
Notes: Attributed as related to study treatment.
Frequency: 2 affected / 3 at risk

Adverse event: Dermal change: skin discoloration
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Skin turned a green color. Attributed as related to study treatment.
Frequency: 1 affected / 3 at risk

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

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Attributed as probably related to study treatment.
Frequency: 2 affected / 3 at risk

Adverse event: Fever (in absence of infection)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 3 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 3 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 3 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 3 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 3 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 3 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Pain - headache
Serious: no
Organ System: Nervous system disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 3 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Attributed as related to study treatment.
Frequency: 1 affected / 3 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Transaminases - AST/ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 3 at risk

Adverse event: Death due to disease progression
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Patient experienced disease progression ultimately resulting in death.
Frequency: 1 affected / 6 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Determined to be unrelated to study - occurred when patient discontinuing heart medication which resulted in heart failure.
Frequency: 1 affected / 6 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 6 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 6 at risk

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

Adverse event: Dermal change: skin discoloration
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Skin turned a green color. Attributed as related to study treatment.
Frequency: 5 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Attributed as probably related to study treatment.
Frequency: 5 affected / 6 at risk

Adverse event: Fever (in absence of infection)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 6 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 6 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 6 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 3 affected / 6 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 6 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 6 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 6 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 6 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 6 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 6 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 6 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 6 at risk

Adverse event: Pain - headache
Serious: no
Organ System: Nervous system disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 6 at risk

Adverse event: Pain - myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 6 at risk

Adverse event: Pain - pelvic
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 6 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 6 at risk

Adverse event: Transaminases - AST/ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 3 affected / 6 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 3 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 6 at risk

Adverse event: Death due to disease progression
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Patient experienced disease progression ultimately resulting in death.
Frequency: 1 affected / 13 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Infection with grade 3 or 4 neutrophils
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Obstruction, GU: left ureter
Serious: yes
Organ System: Renal and urinary disorders
Notes: Patient had undergone stent replacement prior to registration on-study - event was determined to be related to that and not to study treatment.
Frequency: 1 affected / 13 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 5 affected / 13 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 13 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 13 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 4 affected / 13 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 6 affected / 13 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 13 at risk

Adverse event: Cytokine release syndrome (infusion reaction)
Serious: no
Organ System: Investigations
Notes: Attributed as related to study treatment.
Frequency: 3 affected / 13 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dermal change: skin discoloration
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Skin turned a green color. Attributed as related to study treatment.
Frequency: 11 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 3 affected / 13 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Attributed as probably related to study treatment.
Frequency: 10 affected / 13 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 13 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 13 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 5 affected / 13 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 6 affected / 13 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 3 affected / 13 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 13 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 13 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 5 affected / 13 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 13 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Attributed as possibly related to study treatment.
Frequency: 4 affected / 13 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 13 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 13 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 13 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 7 affected / 13 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 13 at risk

Adverse event: Pain - dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain - headache
Serious: no
Organ System: Nervous system disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 13 at risk

Adverse event: Pain - lacrimal
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain - myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 13 at risk

Adverse event: Petechiae
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 13 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Attributed as related to study treatment.
Frequency: 3 affected / 13 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 13 at risk

Adverse event: Renal - Other (hematuria)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Transaminases - AST/ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 3 affected / 13 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 1 affected / 13 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Attributed as possibly related to study treatment.
Frequency: 2 affected / 13 at risk

Adverse event: Weight increased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk