TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00623181

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 70 affected / 110 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 39 affected / 110 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 92 affected / 110 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 68 affected / 110 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 74 affected / 110 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 14 affected / 110 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 56 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 18 affected / 56 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 56 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 56 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 75 affected / 110 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 12 affected / 110 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 15 affected / 110 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 12 affected / 110 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 19 affected / 110 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 7 affected / 110 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 54 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 21 affected / 54 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 54 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 54 at risk
Study: NCT00623194

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 146 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 146 at risk

Adverse event: Gastroenteritis shigella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 146 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 146 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 146 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 146 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 146 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 146 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 146 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 146 at risk

Adverse event: Hypoglycaemia unconsciousness
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 146 at risk

Adverse event: Burns second degrees
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 146 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 71 affected / 146 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 146 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 146 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 146 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 146 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 146 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 146 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 146 at risk

Adverse event: Acute Tonsilliitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 146 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 146 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 146 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 146 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 146 at risk
Study: NCT00623441

Adverse event: Cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 135 affected / 7832 at risk
Study: NCT00623467

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 343 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 343 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 343 at risk

Adverse event: Red blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 4 affected / 343 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 5 affected / 343 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 343 at risk
Study: NCT00623545

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 28 at risk

Adverse event: Claustrophobia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 28 at risk
Study: NCT00623714

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

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

Adverse event: Muscle contractions involuntary
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

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

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

Adverse event: Muscle contractions involuntary
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

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

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

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

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk
Study: NCT00623779

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 41 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 41 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Drug intolerance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 41 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 46 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk
Study: NCT00624013

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 44 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: subject developed skin rash
Frequency: 1 affected / 44 at risk

Adverse event: moved out of the country
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 44 at risk

Adverse event: moved out of the country
Serious: no
Organ System: Social circumstances
Frequency: 3 affected / 45 at risk
Study: NCT00624195

Adverse event: Psychiatric Event
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk
Study: NCT00624221

Adverse event: graft dislocation and reattachment
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 20 at risk

Adverse event: Transplant rejection
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 20 at risk

Adverse event: graft dislocation and reattachment
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 20 at risk
Study: NCT00624286

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 211 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 211 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 211 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Exposure to toxic agent
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 211 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 211 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 211 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 211 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 211 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 211 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 205 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 205 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 205 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 205 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 205 at risk
Study: NCT00624377

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2031 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2031 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2031 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2031 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2031 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2031 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 2031 at risk

Adverse event: Respiratory therapy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2031 at risk

Adverse event: Infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2031 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2031 at risk

Adverse event: Cynosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2031 at risk
Study: NCT00624520

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Includes Ablation procedures
Frequency: 2 affected / 56 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Cardiac disorders
Notes: Includes syncope, dizziness, hypotension
Frequency: 1 affected / 56 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Cardiac disorders
Notes: Includes admissions for inappropriate device firings, lead revisions
Frequency: 2 affected / 56 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Vascular disorders
Notes: Includes carotid artery surgery
Frequency: 1 affected / 56 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: includes respiratory infection
Frequency: 2 affected / 56 at risk

Adverse event: Nasal polyps
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes nasal polypectomy
Frequency: 1 affected / 56 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiomyopathy, sudden cardiac death
Frequency: 1 affected / 47 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Tachycardia unknown origin
Frequency: 1 affected / 47 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Cardiac disorders
Notes: Includes syncope, dizziness, hypotension
Frequency: 2 affected / 47 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Cardiac disorders
Notes: Includes admissions for inappropriate device firings, lead revisions
Frequency: 1 affected / 47 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Includes colonoscopy
Frequency: 1 affected / 47 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Cerebrovascular Disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 47 at risk
Study: NCT00624650

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 17 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 17 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 16 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 16 at risk
Study: NCT00624819

Adverse event: Broncopneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 391 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 157 affected / 264 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 90 affected / 264 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 67 affected / 264 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 49 affected / 263 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 35 affected / 263 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 30 affected / 263 at risk

Adverse event: Fever (Axillary temperature ≥ 37.5°C)
Serious: no
Organ System: General disorders
Frequency: 13 affected / 263 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 20 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 34 affected / 64 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 14 affected / 64 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 15 affected / 64 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 12 affected / 64 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 6 affected / 64 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 6 affected / 64 at risk

Adverse event: Fever (Axillary temperature ≥ 37.5°C)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 64 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 54 affected / 100 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 21 affected / 100 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 20 affected / 100 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 12 affected / 100 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 8 affected / 100 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 13 affected / 100 at risk

Adverse event: Fever (Axillary temperature ≥ 37.5°C)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 100 at risk
Study: NCT00625131

Adverse event: Surgical Intervention, non-study related
Serious: no
Organ System: General disorders
Notes: Several participants had minor surgical interventions during the course of the study that were not related to study participation.
Frequency: 3 affected / 38 at risk

Adverse event: Exacerbation of pre-existing PTSD symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 38 at risk

Adverse event: Sleep disturbance and/or increased nightmares
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 38 at risk

Adverse event: Itching and/or skin rash at site of patch placement
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 38 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Gas and/or hemorrhoid pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hospitalization for pre-existing Chronic Obstructive Pulmonary Disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hospitalization for preexisting circulatory disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Surgical Intervention, non-study related
Serious: no
Organ System: General disorders
Notes: Several participants had minor surgical interventions during the course of the study that were not related to study participation.
Frequency: 2 affected / 44 at risk

Adverse event: Exacerbation of pre-existing PTSD symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 44 at risk

Adverse event: Sleep disturbance and/or increased nightmares
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 44 at risk

Adverse event: Itching and/or skin rash at site of patch placement
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 44 at risk

Adverse event: Orthopedic accident, not study related
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 44 at risk
Study: NCT00625365

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 1053 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 1053 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 1053 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 1053 at risk
Study: NCT00625729

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Ventricular arrhythmia - Bigeminy
Frequency: 1 affected / 6 at risk

Adverse event: Death - Disease Progression NOS
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: ANC \<500 at day +35
Frequency: 1 affected / 6 at risk

Adverse event: Pulmonary - obstruction/stenosis of airway
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk
Study: NCT00625820

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Notes: One patient did develop kidney stones requiring stone extraction and lithotripsy after.
Frequency: 1 affected / 17 at risk