TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00794118

Adverse event: Infusion related reaction
Serious: no
Organ System: Immune system disorders
Frequency: 13 affected / 272 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 272 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 272 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 272 at risk

Adverse event: Angioedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 272 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 272 at risk
Study: NCT00794144

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 66 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 66 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 66 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 66 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 66 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 66 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 66 at risk
Study: NCT00794157

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 114 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 114 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 114 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 114 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 116 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 116 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 116 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 116 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 117 at risk

Adverse event: Cor pulmonale
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 117 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 117 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Concomitant disease progression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 117 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 117 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 117 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 117 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 117 at risk
Study: NCT00794313

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

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk
Study: NCT00794365

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 330 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 330 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 330 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 330 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 330 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 330 at risk
Study: NCT00794508

Adverse event: Infection requiring hospitalization
Serious: yes
Organ System: Immune system disorders
Frequency: 5 affected / 10 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 10 at risk
Study: NCT00794560

Adverse event: hematoma at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 36 at risk

Adverse event: mild injection site irritation/burning
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 36 at risk

Adverse event: hematoma in general
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 36 at risk

Adverse event: Induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 36 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Allergy / hypersensitivity
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: hospitalisation due to allergy, completely recovered
Frequency: 1 affected / 36 at risk

Adverse event: hematoma at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 36 at risk

Adverse event: mild injection site irritation/burning
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 36 at risk

Adverse event: hematoma in general
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: hematoma at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 44 at risk

Adverse event: mild injection site irritation/burning
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 44 at risk

Adverse event: hematoma in general
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 44 at risk

Adverse event: site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 44 at risk

Adverse event: Induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 44 at risk

Adverse event: hematoma at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 38 at risk

Adverse event: mild injection site irritation/burning
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 38 at risk

Adverse event: hematoma in general
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 38 at risk
Study: NCT00794820

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 24 affected / 65 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 65 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 65 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 65 at risk

Adverse event: Bacteria Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 65 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 65 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 65 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 42 affected / 65 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 65 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 65 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 65 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 41 affected / 65 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 21 affected / 65 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 65 at risk

Adverse event: Other Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 65 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 65 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 65 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 65 at risk
Study: NCT00795002

Adverse event: Tumour lysis syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 39 at risk

Adverse event: Oral and/or Gastrointestinal mucositis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Cardiac dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 39 at risk

Adverse event: General disorders-other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Tumour lysis syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 39 at risk

Adverse event: Oral and/or Gastrointestinal mucositis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Cardiac dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 39 at risk

Adverse event: General disorders-other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk
Study: NCT00795210

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Edema/Extremity Swelling
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: elevated fasting blood sugar
Frequency: 2 affected / 11 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk
Study: NCT00795366

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 42 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 54 at risk
Study: NCT00795509

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 343 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 343 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 343 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 6 affected / 343 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 343 at risk

Adverse event: Residual urine volume increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 343 at risk

Adverse event: Dizzines
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 343 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 343 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 343 at risk
Study: NCT00795704

Adverse event: Hospitalisation
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Warfarin intoxication after recent dose increase. Unrelated to study medication. Held study medication for 3 weeks per PCP, then resumed and completed.
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: GERD, abdominal pain, gas, bloating, constipation
Frequency: 3 affected / 12 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: UTI, Influenza, skin infection
Frequency: 2 affected / 12 at risk

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

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: GERD, abdominal pain, gas, bloating, constipation
Frequency: 3 affected / 12 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: itching, watery eyes, sinus headache
Frequency: 1 affected / 12 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: UTI, Influenza, skin infection
Frequency: 1 affected / 12 at risk
Study: NCT00795769

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: post stem cell infusion
Frequency: 9 affected / 49 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: post stem cell infusion. Also had \> two point increase from baseline on MAT nausea score
Frequency: 3 affected / 49 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: post stem cell infusion
Frequency: 6 affected / 49 at risk
Study: NCT00795886

Adverse event: Transplant related mortality
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Death not related to relapse
Frequency: 8 affected / 63 at risk

Adverse event: Venoocclusive disease
Serious: no
Organ System: Hepatobiliary disorders
Notes: Looking at non-severe VOD. Important to understand this as it has been noted in a portion of patients using sirolimus.
Frequency: 3 affected / 63 at risk
Study: NCT00795951

Adverse event: Worsening of rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 102 at risk

Adverse event: Flare-up of rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 102 at risk

Adverse event: Boil on forehead
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 102 at risk

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 102 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 102 at risk

Adverse event: Reaction around panel 2.1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Edema, vesiculation pain on hands
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Worsening of underlying condition
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Slight worsening of spot on leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Lesion on right thumb
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Worsening of dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Reaction on place of panel
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 102 at risk
Study: NCT00796224

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

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

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

Adverse event: Treatment failure
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk
Study: NCT00796302

Adverse event: Initial insomnia
Serious: no
Organ System: General disorders
Frequency: 29 affected / 80 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 80 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 80 at risk

Adverse event: Appetite decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 80 at risk

Adverse event: Appetite increase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 80 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 80 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 80 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 20 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 17 affected / 80 at risk

Adverse event: Initial insomnia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 73 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 73 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 73 at risk

Adverse event: Appetite decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 73 at risk

Adverse event: Appetite increase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 73 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 73 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 73 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 73 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 16 affected / 73 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 16 affected / 73 at risk
Study: NCT00796315

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 9 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 17 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 15 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk