TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00789750

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

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 274 at risk

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

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

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

Adverse event: Squamous cell carcinoma of lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 274 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 274 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 274 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 274 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 274 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 277 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 277 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 277 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 277 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 277 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 277 at risk
Study: NCT00789815

Adverse event: Intubation due to massive bleeding after bronchial biopsy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Bleeding from the biopsy site is the risk of bronchial biospy. After intubation, the patient was stabilized. He recovered later and discharged without sequelae.
Frequency: 1 affected / 250 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumothorax is the risk of transbronchial lung biopsy. After chest tube draining, the patient recovered and discharged without any sequelae.
Frequency: 1 affected / 250 at risk

Adverse event: Hypoxemia during flexible bronchoscopy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The hypoxemia is the risk of bronchoscopy and sedation. This the primary outcome of this study.
Frequency: 97 affected / 250 at risk

Adverse event: Hypotension during flexible bronchoscopy
Serious: no
Organ System: Cardiac disorders
Notes: The hypotension is the risk of sedation. This is the primary outcome of this study.
Frequency: 18 affected / 250 at risk

Adverse event: Hypoxemia during flexible bronchoscopy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The hypoxemia is the risk of bronchoscopy and sedation. This the primary outcome of this study.
Frequency: 89 affected / 250 at risk

Adverse event: Hypotension during flexible bronchoscopy
Serious: no
Organ System: Cardiac disorders
Notes: The hypotension is the risk of sedation. This is the primary outcome of this study.
Frequency: 11 affected / 250 at risk
Study: NCT00789854

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 228 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 228 at risk

Adverse event: Restlessness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 228 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 228 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 228 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 228 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 228 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 228 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 228 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 228 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 228 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 231 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 231 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 231 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 231 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 231 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 231 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 231 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 231 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 231 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 229 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 229 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 229 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 229 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 229 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 229 at risk
Study: NCT00789867

Adverse event: Injury in luvula sustained from pressure of tube during bronchoscopy 03/04/2009
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Mild self limiting influenza like systemic response
Serious: no
Organ System: Immune system disorders
Frequency: 14 affected / 17 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 10 at risk

Adverse event: Mild self limiting influenza like systemic response
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 10 at risk

Adverse event: Mild self limiting influenza like systemic response
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 8 at risk
Study: NCT00789997

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiopulmonary Arrest
Frequency: 1 affected / 41 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Myocardial infarction/unstable angina
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 41 at risk

Adverse event: Sinusitis/pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 41 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 40 at risk

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

Adverse event: Myocardial infarction/unstable angina
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Severe Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Rectal Occlusion
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 40 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 40 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 40 at risk
Study: NCT00790023

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 237 at risk

Adverse event: Nasal discomort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 237 at risk

Adverse event: Nasal septum disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 237 at risk

Adverse event: Instillation site irritation
Serious: no
Organ System: General disorders
Frequency: 5 affected / 237 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 235 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 235 at risk

Adverse event: Nasal discomort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 235 at risk

Adverse event: Nasal septum disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 235 at risk

Adverse event: Instillation site irritation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 235 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 235 at risk

Adverse event: Nasal discomort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 235 at risk

Adverse event: Nasal septum disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 235 at risk

Adverse event: Instillation site irritation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 235 at risk
Study: NCT00790088

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Endocrine disorders
Notes: defined as blood glucose \>250 mg/dL \[\>13.9 mmol/L\] with either low serum bicarbonate \[\<15 mEq/L\] or low pH \[\<7.3\] and either ketonemia or ketonuria and requiring treatment within a health-care facility
Frequency: 3 affected / 263 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: defined as an episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory blood glucose value \<50mg/dL \[\<2.8 mmol/L\]
Frequency: 9 affected / 263 at risk

Adverse event: Other diabetes-related AE
Serious: yes
Organ System: Endocrine disorders
Notes: angioplasty, diabetic foot ulcer; ischemic heart disease; pancreas and liver transplantations, suicide attempt, poor glycemic control
Frequency: 6 affected / 263 at risk

Adverse event: Non Diabetes-related serious adverse events
Serious: yes
Organ System: Endocrine disorders
Frequency: 6 affected / 263 at risk
Study: NCT00790556

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Infusion site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 14 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Upper respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk
Study: NCT00790569

Adverse event: Neurobehavioral Adverse Effects
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant described hearing voices
Frequency: 1 affected / 137 at risk

Adverse event: Neurobehavioral Adverse Events
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant reported mood disturbance
Frequency: 1 affected / 137 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Participants complained of skin rashes
Frequency: 2 affected / 137 at risk

Adverse event: Participant Death
Serious: yes
Organ System: General disorders
Notes: Participant died during study participation
Frequency: 2 affected / 45 at risk

Adverse event: Participant Death
Serious: yes
Organ System: General disorders
Notes: Participant died during study participation
Frequency: 1 affected / 133 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Participant was hospitalized with symptoms of heat attack
Frequency: 1 affected / 133 at risk
Study: NCT00790673

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue
Frequency: 2 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: HEADACHE
Frequency: 4 affected / 6 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: Palpitations
Frequency: 2 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: HEADACHE
Frequency: 2 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: HEADACHE
Frequency: 2 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: HEADACHE
Frequency: 4 affected / 8 at risk
Study: NCT00790738

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 5 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 5 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: excitment
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk
Study: NCT00790855

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: Elevated Creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 25 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 25 at risk

Adverse event: Liver function abnormality
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 25 at risk
Study: NCT00790985

Adverse event: nausea dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 108 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 108 at risk

Adverse event: nausea dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 115 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 115 at risk
Study: NCT00791089

Adverse event: Cardiac Tamponnade
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 6 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 6 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fluid gain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 6 at risk

Adverse event: Spot on Face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Painful vericose veins
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk
Study: NCT00791258

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 999 at risk

Adverse event: depession
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 999 at risk

Adverse event: Oesophageal rupture
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 999 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 999 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 999 at risk

Adverse event: Non small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 999 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 999 at risk

Adverse event: vaginal haemhorrage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 999 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 999 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 999 at risk

Adverse event: protate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 999 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 999 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 86 affected / 999 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 999 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 103 affected / 999 at risk
Study: NCT00791518

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1084 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1084 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1084 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1084 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1084 at risk
Study: NCT00791557

Adverse event: Infusion related reaction
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Myelosuppression
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk