TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00673673

Adverse event: Thromboytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 39 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 39 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Neurtropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 39 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 39 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 39 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

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

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 39 at risk

Adverse event: Hand-Foot Syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 39 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 39 at risk

Adverse event: Electrolytes Imbalence
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Deep Vein Thrombosis/Pulmonary Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 39 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 39 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 39 at risk
Study: NCT00673790

Adverse event: Basal ganglia haemorrage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 223 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 223 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 223 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 223 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 223 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 223 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 223 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 212 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 212 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 212 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 212 at risk

Adverse event: Myocardial infaction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 212 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 212 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 212 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 212 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 212 at risk

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

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

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 102 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 102 at risk
Study: NCT00673881

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 25 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 25 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 25 at risk
Study: NCT00673933

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 20 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 20 at risk

Adverse event: Skin burning sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 20 at risk

Adverse event: Skin warm
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 20 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Non treatment site, included under both Visonac and vehicle arm
Frequency: 1 affected / 20 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Skin burning sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 20 at risk

Adverse event: Skin warm
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 20 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Non treatment site, included under both Visonac and vehicle arm
Frequency: 1 affected / 20 at risk
Study: NCT00674115

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk
Study: NCT00674128

Adverse event: Device Pocket Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk

Adverse event: Device Pocket Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk
Study: NCT00674154

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Admission to hospital due to pain and infection from kidney stones.
Frequency: 1 affected / 20 at risk

Adverse event: Eye infection
Serious: no
Organ System: Eye disorders
Notes: Local or bilateral eye infection.
Frequency: 1 affected / 20 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Notes: Symptoms classified and treated as cystitis
Frequency: 1 affected / 20 at risk

Adverse event: Lower leg cramp
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain or cramp in one or both of the lower legs.
Frequency: 1 affected / 20 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory infection classified and treated as pneumonia.
Frequency: 2 affected / 20 at risk

Adverse event: Eye operation
Serious: yes
Organ System: Eye disorders
Notes: Admission to hospital for operation at the eye lens.
Frequency: 1 affected / 22 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Upper abdominal self-limitating pain.
Frequency: 1 affected / 22 at risk

Adverse event: Steatosis hepatis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diagnosed by chance during examination for kidney stones
Frequency: 1 affected / 22 at risk

Adverse event: Hand dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Red eczema on two fingers.
Frequency: 1 affected / 22 at risk

Adverse event: Eye infection
Serious: no
Organ System: Eye disorders
Notes: Local or bilateral eye infection.
Frequency: 1 affected / 22 at risk

Adverse event: Heamatoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local heamatoma after tissue biopsy.
Frequency: 1 affected / 22 at risk

Adverse event: Lower leg cramp
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain or cramp in one or both of the lower legs.
Frequency: 1 affected / 22 at risk

Adverse event: Voice change
Serious: no
Organ System: Nervous system disorders
Notes: Temporary voice changes after neck operation for hyperparathyroidism not classified as recurrent laryngeal nerve palsy.
Frequency: 1 affected / 22 at risk

Adverse event: Changed sense of touch
Serious: no
Organ System: Nervous system disorders
Notes: Experience of a change in the sense of touch in face, arms or legs.
Frequency: 1 affected / 22 at risk
Study: NCT00674206

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 6 at risk

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

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

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

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk
Study: NCT00674219

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 10 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 7 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk
Study: NCT00674297

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Lupus flare
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Myalgia with high CPK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Myalgia with normal CPK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 41 at risk

Adverse event: Recurrent deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 41 at risk
Study: NCT00674479

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 51 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 51 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Left Basilic Vein Thrombus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Hemorrhage CNS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 51 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 51 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 51 at risk

Adverse event: Joint-Effusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk
Study: NCT00674739

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Worsened iron deficiency anemia
Frequency: 1 affected / 178 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Notes: Worsening migraine headache
Frequency: 1 affected / 178 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Syncope
Frequency: 1 affected / 178 at risk

Adverse event: Application site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 178 at risk

Adverse event: Application site irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 178 at risk

Adverse event: Pelvic mass
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 195 at risk

Adverse event: Acute abdomen
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Acute Surgical Abdomen
Frequency: 1 affected / 195 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Cholecystolithiasis
Frequency: 1 affected / 195 at risk

Adverse event: Application site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 195 at risk

Adverse event: Application site irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 195 at risk

Adverse event: Application site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Application site irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 97 at risk
Study: NCT00674765

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 43 affected / 81 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 16 affected / 81 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 81 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 81 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 22 affected / 75 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 6 affected / 75 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 75 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 75 at risk
Study: NCT00675103

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

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Infusion-Related Reaction
Serious: no
Organ System: General disorders
Frequency: 4 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Gout (flare)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 7 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 7 at risk

Adverse event: Diabete Mellitus Non-Insulin Dependent
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: New Tophus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Wound drainage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 7 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk
Study: NCT00675259

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 33 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 33 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 33 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 33 at risk

Adverse event: Wound Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 33 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 28 affected / 33 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 33 at risk

Adverse event: Infection with normal ANC
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 33 at risk

Adverse event: Peripherial neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 33 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 33 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 33 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 33 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 33 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 33 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 33 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 33 at risk
Study: NCT00675415

Adverse event: Respiration abnormal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 101 affected / 124 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 57 affected / 124 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 124 at risk

Adverse event: Respiration abnormal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 95 affected / 123 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 85 affected / 123 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 123 at risk
Study: NCT00675441

Adverse event: Sudden Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk
Study: NCT00675584

Adverse event: hospitalization due to exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 139 at risk

Adverse event: other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 139 at risk

Adverse event: nausea or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 139 at risk

Adverse event: hospitalization due to exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 139 at risk

Adverse event: other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 139 at risk

Adverse event: nausea or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 139 at risk