TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01533428

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 186 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 186 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 186 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 186 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 186 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 183 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 183 at risk

Adverse event: Noncardiac chest pain
Serious: yes
Organ System: General disorders
Notes: Noncardiac chest pain
Frequency: 1 affected / 183 at risk

Adverse event: Postprocedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 183 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 183 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 183 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 183 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 183 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 183 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 183 at risk
Study: NCT01533597

Adverse event: Dry mouth
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 35 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 35 at risk
Study: NCT01533688

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 63 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 63 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 63 at risk

Adverse event: Rectal burning sensation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 63 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 60 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Rectal burning sensation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 60 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 63 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 63 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 63 at risk

Adverse event: Rectal burning sensation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 63 at risk
Study: NCT01533753

Adverse event: Cardiac murmur
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Balance problem
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

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

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

Adverse event: Insomnia
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
Study: NCT01533974

Adverse event: Disturbed Sleep
Serious: no
Organ System: General disorders
Notes: Vivid, strange, weird dreams; common side effect of NRT
Frequency: 7 affected / 224 at risk

Adverse event: Skin irritation
Serious: no
Organ System: General disorders
Notes: Burning, itching, rash at patch site; common side effect of NRT.
Frequency: 3 affected / 224 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Notes: Muscle ache and soreness at patch site; common side effect of NRT patch.
Frequency: 1 affected / 224 at risk

Adverse event: Stomach and digestive issues
Serious: no
Organ System: General disorders
Notes: Indigestion, nausea, and upset stomach; common side effect of NRT patch.
Frequency: 3 affected / 224 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: Dry mouth; common side effect of NRT patch.
Frequency: 1 affected / 224 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Headache off and on for past week; probably related
Frequency: 1 affected / 224 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Notes: Anxiety and difficulty concentrating when first using the patch; common side effect of patch
Frequency: 1 affected / 224 at risk

Adverse event: Disturbed Sleep
Serious: no
Organ System: General disorders
Notes: Vivid, strange, weird dreams; common side effect of NRT
Frequency: 1 affected / 226 at risk

Adverse event: Skin irritation
Serious: no
Organ System: General disorders
Notes: Burning, itching, rash at patch site; common side effect of NRT.
Frequency: 1 affected / 226 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Notes: Muscle ache and soreness at patch site; common side effect of NRT patch.
Frequency: 1 affected / 226 at risk

Adverse event: Stomach and digestive issues
Serious: no
Organ System: General disorders
Notes: Indigestion, nausea, and upset stomach; common side effect of NRT patch.
Frequency: 1 affected / 226 at risk

Adverse event: MRSA infection
Serious: no
Organ System: General disorders
Notes: Participant was treated for a MRSA infection; not related.
Frequency: 1 affected / 226 at risk
Study: NCT01534143

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

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

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

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

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1 at risk
Study: NCT01534182

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 230 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 230 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 230 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 230 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 10 affected / 28 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 36 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Injection site extravasation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk
Study: NCT01534195

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Mucous Discharge (OU)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk
Study: NCT01534273

Adverse event: Visual field defect
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Procedural headache
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

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

Adverse event: Procedural headache
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Procedural dizziness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Procedural dizziness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk
Study: NCT01534416

Adverse event: Stress urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Notes: Stress incontinence requiring a midurethral sling
Frequency: 1 affected / 68 at risk

Adverse event: Incisional Infection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 68 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 68 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: skin laceration from the morcellator
Frequency: 1 affected / 68 at risk

Adverse event: Cervical infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 68 at risk

Adverse event: Retropubic hematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 68 at risk

Adverse event: Bladder performation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: bladder perforation during a concomitant retropubic midurethral sling procedure
Frequency: 1 affected / 68 at risk

Adverse event: Seizure
Serious: no
Organ System: General disorders
Notes: unknown etiology
Frequency: 1 affected / 68 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: General disorders
Notes: ER visit for nausea, vomiting, and headache
Frequency: 1 affected / 68 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 64 at risk

Adverse event: Incisional Infection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 64 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 64 at risk

Adverse event: Small Bowel Mesenteric Hematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: a small bowel mesenteric hematoma caused by Veress needle injury that did not require surgical management
Frequency: 1 affected / 64 at risk

Adverse event: Cervical infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 64 at risk

Adverse event: Retropubic hematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 64 at risk
Study: NCT01534494

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Forearm fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 10 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk
Study: NCT01534520

Adverse event: Intolerable Pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Pain at time of IUD insertion
Frequency: 1 affected / 29 at risk
Study: NCT01534637

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Associated with significant weight loss or malnutrition (e.g., inadequate oral caloric and/or fluid intake); IV fluids, tube feedings or TPN indicated
Frequency: 1 affected / 21 at risk

Adverse event: Low Leukocytes (total WBC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 21 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain: Abdomen
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 4 non serious (grade 1 or 2) occurrances
Frequency: 4 affected / 21 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 non serious (grade 1-2) occurances
Frequency: 2 affected / 21 at risk

Adverse event: Neutrophils/granulocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 4 non serious (grade 1-2) occurances
Frequency: 4 affected / 21 at risk

Adverse event: Albumin, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 21 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2 at risk
Study: NCT01534663

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk
Study: NCT01534897

Adverse event: Skin Changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 10 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 10 at risk

Adverse event: Palmar-Plantar Erythrodysethesias
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Creatinine Increase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk
Study: NCT01534975

Adverse event: Flushing
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: patients reported flushing after administration of contrast
Frequency: 98 affected / 136 at risk

Adverse event: Flushing
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: patients reported flushing after administration of contrast
Frequency: 122 affected / 133 at risk

Adverse event: Flushing
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: patients reported flushing after administration of contrast
Frequency: 152 affected / 160 at risk

Adverse event: Flushing
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: patients reported flushing after administration of contrast
Frequency: 52 affected / 84 at risk
Study: NCT01535235

Adverse event: Elevation in serum creatinine
Serious: no
Organ System: Renal and urinary disorders
Notes: One subject had elevation of serum creatinine and was withdrawn from the study at Week 12 for this. However, labs drawn at that time showed that the serum creatinine had returned to baseline and was likely secondary to another medical condition.
Frequency: 1 affected / 16 at risk
Study: NCT01535326

Adverse event: Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: one patient received polypectomy during withdrawal phase. Perforation was found immediately and hemoclips were applied. She recovered uneventfully after supportive care.
Frequency: 1 affected / 90 at risk
Study: NCT01535599

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 342 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 342 at risk
Study: NCT01535638

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 16 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk