TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00267046

Adverse event: Increased thickness of oral mucosa
Serious: no
Organ System: General disorders
Frequency: 30 affected / 32 at risk

Adverse event: Altered taste
Serious: no
Organ System: General disorders
Frequency: 20 affected / 32 at risk

Adverse event: Flushing
Serious: no
Organ System: General disorders
Frequency: 16 affected / 32 at risk

Adverse event: Film coating in mouth
Serious: no
Organ System: General disorders
Frequency: 17 affected / 32 at risk

Adverse event: Increased sensitivity in tongue or gums
Serious: no
Organ System: General disorders
Frequency: 15 affected / 32 at risk

Adverse event: Warm sensation
Serious: no
Organ System: General disorders
Frequency: 11 affected / 32 at risk

Adverse event: Increased saliva
Serious: no
Organ System: General disorders
Frequency: 8 affected / 32 at risk

Adverse event: Increased thickness of oral mucosa
Serious: no
Organ System: General disorders
Frequency: 5 affected / 16 at risk

Adverse event: Altered taste
Serious: no
Organ System: General disorders
Frequency: 4 affected / 16 at risk

Adverse event: Flushing
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Film coating in mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Increased sensitivity in tongue or gums
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Increased saliva
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk
Study: NCT00267085

Adverse event: Neck pain
Serious: yes
Organ System: General disorders
Notes: Unrelated to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Back pain
Serious: yes
Organ System: General disorders
Notes: Unrelated to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Dermatology/skin (other)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 10 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 10 at risk

Adverse event: Nasal/paranasal reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Pain (joint)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Pain (muscle)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Pain (NOS)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pain (Other)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Pruitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 10 at risk

Adverse event: rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk
Study: NCT00267111

Adverse event: Local erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 54 at risk

Adverse event: Local erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 53 at risk
Study: NCT00267150

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk
Study: NCT00267696

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 45 at risk

Adverse event: Cerebrovascular events
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 45 at risk

Adverse event: Hematologic
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 and 4
Frequency: 39 affected / 45 at risk
Study: NCT00267774

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 509 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 29 affected / 509 at risk

Adverse event: Repeat vascularization
Serious: yes
Organ System: Cardiac disorders
Frequency: 33 affected / 509 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 496 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 43 affected / 496 at risk

Adverse event: Repeat vascularization
Serious: yes
Organ System: Cardiac disorders
Frequency: 47 affected / 496 at risk
Study: NCT00268242

Adverse event: Fever or Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 20 affected / 24 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 24 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 24 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 24 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 24 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 24 at risk

Adverse event: Fatigue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 24 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 24 at risk
Study: NCT00268346

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 18 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 18 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 18 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 40 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Mucositis/Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 40 at risk
Study: NCT00269919

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 39 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 39 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 39 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 39 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 39 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 39 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 39 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 39 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 39 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 39 at risk
Study: NCT00270296

Adverse event: Grade 3 or 4 Laboratory Event
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Neutropenia or anemia or liver function test (LFT) abnormality
Frequency: 42 affected / 285 at risk

Adverse event: Grade 3 or 4 Laboratory Event
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Neutropenia or anemia or liver function test (LFT) abnormality
Frequency: 32 affected / 275 at risk

Adverse event: Grade 3 or 4 Laboratory Event
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Neutropenia or anemia or liver function test (LFT) abnormality
Frequency: 48 affected / 170 at risk
Study: NCT00270790

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 21 affected / 21 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 21 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 21 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 21 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk
Study: NCT00270998

Adverse event: Urinary incontinence surgery
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 149 at risk

Adverse event: Angioplasty of heart
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 149 at risk

Adverse event: Hernia hiatus repair
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 149 at risk

Adverse event: Left femoral hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 149 at risk

Adverse event: Oophorectomy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 149 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 149 at risk

Adverse event: Fractured right leg and ankle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 149 at risk

Adverse event: Lumbar decompression surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 149 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 146 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 146 at risk

Adverse event: Right knee surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 146 at risk

Adverse event: Urinary incontinence surgery
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 150 at risk

Adverse event: Angioplasty of heart
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Left eye surgery for cancer
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 150 at risk

Adverse event: Non-cardiac chest pain and anxiety
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 150 at risk

Adverse event: Kidney surgery
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Uterine cancer
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 150 at risk
Study: NCT00271011

Adverse event: Death, Cause Unknown
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Gastrointestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 13 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 13 at risk

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

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 13 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 13 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 13 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 13 at risk

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

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 13 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 13 at risk

Adverse event: Extrapyramidal/involuntary movement/restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 13 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 13 at risk

Adverse event: Watery eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 13 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 13 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 13 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 13 at risk
Study: NCT00271024

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Motor Vehicle Collision
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 26 affected / 154 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 5 affected / 154 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 57 affected / 154 at risk

Adverse event: Lightheaded or dizzy
Serious: no
Organ System: General disorders
Frequency: 37 affected / 154 at risk

Adverse event: Flushed or warm
Serious: no
Organ System: General disorders
Frequency: 36 affected / 154 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 91 affected / 154 at risk

Adverse event: Agitation or anxiety
Serious: no
Organ System: General disorders
Frequency: 82 affected / 154 at risk

Adverse event: Increased Sexual Desire
Serious: no
Organ System: General disorders
Frequency: 37 affected / 154 at risk

Adverse event: Benign Brain Mass
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Participant reported this during time of study; however, diagnosed as having developed prior to study participation
Frequency: 1 affected / 161 at risk

Adverse event: Suicidal Ideation Remitting in 2 Days with Recurrence
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 161 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 52 affected / 161 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 10 affected / 161 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 67 affected / 161 at risk

Adverse event: Lightheaded or dizzy
Serious: no
Organ System: General disorders
Frequency: 57 affected / 161 at risk

Adverse event: Flushed or warm
Serious: no
Organ System: General disorders
Frequency: 46 affected / 161 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 98 affected / 161 at risk

Adverse event: Agitation or anxiety
Serious: no
Organ System: General disorders
Frequency: 76 affected / 161 at risk

Adverse event: Increased Sexual Desire
Serious: no
Organ System: General disorders
Frequency: 45 affected / 161 at risk
Study: NCT00271505

Adverse event: Haemoptysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pulmonary Hemmorhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Fatigue
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Perforation Duodenum G4
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Rt Ing Hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Fatigue & Infection G3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Mild Anemia of Chronic Disease and Fatigue
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 40 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 40 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 40 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 40 at risk

Adverse event: Nail Change
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 40 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 21 affected / 40 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 40 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 40 at risk
Study: NCT00271596

Adverse event: worsening depression with suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Ejaculation disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 17 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: worsening depression with suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk
Study: NCT00272168

Adverse event: Medical Hospitalization
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 47 at risk

Adverse event: Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 47 at risk

Adverse event: Medical Hospitalization
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 41 at risk

Adverse event: Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 41 at risk