Study: NCT02404155

Adverse event: Prolapsed Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 274 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 274 at risk

Adverse event: Pulmonary Emobolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 274 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 274 at risk

Adverse event: Hospitalization for Clinical Worsening
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 274 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Severe Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 274 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 274 at risk

Adverse event: Atypical Neuroleptic Malignant Syndrome/ Drug Fever
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 274 at risk

Adverse event: Infection/Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 274 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 274 at risk

Adverse event: Severe Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Diffuse Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 274 at risk

Adverse event: Unresponsiveness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 274 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 91 affected / 274 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 51 affected / 274 at risk

Adverse event: Contusion
Serious: no
Organ System: General disorders
Frequency: 12 affected / 274 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 88 affected / 274 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 274 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 112 affected / 274 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 65 affected / 274 at risk

Adverse event: Enuresis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 70 affected / 274 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 35 affected / 274 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 86 affected / 274 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 53 affected / 274 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 144 affected / 274 at risk

Adverse event: Mucosal
Serious: no
Organ System: General disorders
Frequency: 22 affected / 274 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 77 affected / 274 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 36 affected / 274 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 79 affected / 274 at risk

Adverse event: Salivary hypersecretion
Serious: no
Organ System: Endocrine disorders
Frequency: 187 affected / 274 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 145 affected / 274 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 66 affected / 274 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 49 affected / 274 at risk

Adverse event: Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 73 affected / 274 at risk

Adverse event: Urticaria
Serious: no
Organ System: General disorders
Frequency: 59 affected / 274 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 274 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 274 at risk

Adverse event: Tinnitus
Serious: no
Organ System: General disorders
Frequency: 37 affected / 274 at risk

Adverse event: Abnormal Ejaculation/Erectile Dysfunction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 274 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 274 at risk

Adverse event: Diabetes/Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 274 at risk

Adverse event: Disorientation/Confusion
Serious: no
Organ System: General disorders
Frequency: 2 affected / 274 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 274 at risk

Adverse event: Myocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 274 at risk

Adverse event: Myoclonus
Serious: no
Organ System: General disorders
Frequency: 3 affected / 274 at risk