TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01040130

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 143 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 143 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 143 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 143 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 147 at risk

Adverse event: Diabetic nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 147 at risk

Adverse event: Glomerulonephritis membranoproliferative
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 147 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 147 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 147 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 143 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 143 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 143 at risk
Study: NCT01040260

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 53 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 50 at risk
Study: NCT01040624

Adverse event: Constipation - acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Pain - acute
Serious: no
Organ System: General disorders
Frequency: 6 affected / 58 at risk

Adverse event: Constipation - acute
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 58 at risk

Adverse event: Diarrhea - acute
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 58 at risk

Adverse event: Dysuria - acute
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 58 at risk

Adverse event: Abdominal cramping acute
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Obstruction - acute
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 58 at risk

Adverse event: Proctitis - acute
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Rectal bleeding - late
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 58 at risk

Adverse event: Abdominal cramping - late
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Constipation - late
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Diarrhea - acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Abdominal cramping - acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain - acute
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain - acute
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Constipation - acute
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Diarrhea - acute
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 19 at risk

Adverse event: Abdominal cramping acute
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Proctitis - acute
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Rectal bleeding - late
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk
Study: NCT01040689

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Thoracic vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 102 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 102 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 102 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 102 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 101 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 101 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 101 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 101 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 101 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 101 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 101 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 101 at risk

Adverse event: Balanoposthitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 101 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 101 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 101 at risk
Study: NCT01040793

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 149 at risk

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

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

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 149 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Mallory-Weiss syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 150 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 150 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 150 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 150 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 147 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 147 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 147 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 147 at risk
Study: NCT01040845

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 27 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Cold sweat
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk
Study: NCT01041287

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Notes: Stroke
Frequency: 2 affected / 19 at risk
Study: NCT01041495

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: glucosemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 12 at risk
Study: NCT01041976

Adverse event: Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 13 affected / 42 at risk

Adverse event: Medical Hospitalization
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 42 at risk

Adverse event: Arrest & Incarceration
Serious: yes
Organ System: Social circumstances
Frequency: 2 affected / 42 at risk

Adverse event: Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 14 affected / 42 at risk

Adverse event: Medical Hospitalization
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 42 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 42 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: General disorders
Frequency: 2 affected / 42 at risk

Adverse event: Transfer Within Hospital
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk
Study: NCT01042158

Adverse event: Stenosis of the left internal carotid artery, worsening shortness of breath, Right heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 24 at risk
Study: NCT01042392

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 257 at risk

Adverse event: Adenocarcinoma pancreas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 257 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 257 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 257 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 257 at risk

Adverse event: Normochromic normocytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 248 at risk

Adverse event: spine metastasis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 248 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 248 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 248 at risk

Adverse event: liver metastatis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 248 at risk
Study: NCT01042496

Adverse event: Hospitalization due to progression of disease
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Admitted to ER due to symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

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

Adverse event: Worsening of bipolar symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Withdrawal from study due to decrease in mood
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Bruise on back of head near ossiput
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Swollen lymph node
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Rash on left knee
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Abnormal high AST level at study exit
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Abnormal high GGT level at study exit
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Paresthesia of Right Shoulder Blade
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk
Study: NCT01042509

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: pneumonia by Rhodococcus equi
Frequency: 1 affected / 15 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: laryngitis, sinusitis, pneumonia, urinary tract infection and oral herpes simplex virus infection in 1 patient each, bronchitis in 2 and reactivation of cytomegalovirus in 3 patients
Frequency: 9 affected / 15 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Investigations
Notes: Chills, rash an fever
Frequency: 7 affected / 15 at risk
Study: NCT01042600

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 30 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumothorax after randomization
Frequency: 4 affected / 30 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumothorax after randomization
Frequency: 6 affected / 30 at risk
Study: NCT01042795

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 7 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 7 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 7 at risk

Adverse event: Cardiac dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk
Study: NCT01043094

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk
Study: NCT01043146

Adverse event: feeling of cold at infusion site when drug was added to cold saline solution
Serious: no
Organ System: General disorders
Notes: Caused by cold temperature of infusion solution. The event never reoccurred when solution was equilibrated to room temperature prior to injection.
Frequency: 3 affected / 8 at risk

Adverse event: not drug-related traumatic injury (achilles tendon) during sledging 8600 half-lives post drug admin.
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Injury by sheet metal used for tobogganing 18 days after drug administration. Hospitalisation for 3 days (2 nights). Plastic reconstruction of the Achilles tendon, antibiotic treatment and wound dressing. Ambulatory follow up 31 days later.
Frequency: 1 affected / 8 at risk
Study: NCT01043185

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

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Gastroenteritisviral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk
Study: NCT01043393

Adverse event: Adrenal suppression
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Adrenal suppression
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 12 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Sciatica
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk
Study: NCT01043653

Adverse event: Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: All psychiatric hospitalizations that occurred during the study were reported to the local IRB and unrelated to study participation
Frequency: 6 affected / 250 at risk

Adverse event: Medical Hospitalization
Serious: yes
Organ System: General disorders
Notes: All medical hospitalizations that occurred during the study were reported to the local IRB and unrelated to study participation
Frequency: 3 affected / 250 at risk
Study: NCT01043926

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 8 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 8 at risk