TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00939562

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 24 at risk
Study: NCT00939640

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: At day 5 safety visit 1 subject had serum potassium 5.9, an expected potential adverse event in this protocol. There were no associated symptoms or sequelae, and the patient was withdrawn form the study diet as per protocol.
Frequency: 1 affected / 14 at risk
Study: NCT00939692

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk
Study: NCT00939731

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Abdominal tenderness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk
Study: NCT00939796

Adverse event: Tympanic membrane perforation
Serious: no
Organ System: Ear and labyrinth disorders
Notes: In the Lead-In cohort: Unintended TM perforations occurred in 2 of 6 ears recorded as non-serious device-related adverse events, with no sequelae. There were no SAEs.
Frequency: 2 affected / 16 at risk
Study: NCT00939874

Adverse event: PARTNER PREGNANCY
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 37 at risk

Adverse event: RIGHT FLANK/QUADRANT PAIN
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: CEREBRAL ANEURYSM
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 37 at risk

Adverse event: LEFT KIDNEY STONES
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 37 at risk

Adverse event: PROBABLE LUMBAR RADICULOPATHY
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: HOSPITAL ADMISSION FOR MALENA AND FEVERS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: LOWER REPIRATORY TRACT INFECTION
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 37 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 37 at risk

Adverse event: Reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 37 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 37 at risk
Study: NCT00940017

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 21 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 21 at risk

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 21 at risk

Adverse event: Hallucination, visual
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 21 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 21 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk
Study: NCT00940771

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Notes: Pansinusitis requiring hospitalization
Frequency: 1 affected / 10 at risk

Adverse event: Pain, neck and face
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Pain grade 2 associated with parotitis
Frequency: 1 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Fever grade 2 associated with Parotitis or Upper Respiratory Infection
Frequency: 2 affected / 10 at risk

Adverse event: Pain, throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: pain grade 2 associated with Upper Respiratory Infection
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough grade 2 associated with Upper Respiratory Infection
Frequency: 1 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3 vomiting associated with parotitis
Frequency: 1 affected / 10 at risk

Adverse event: Laboratory Abnormality
Serious: no
Organ System: Gastrointestinal disorders
Notes: Elevated Bilirubin, grade 3
Frequency: 1 affected / 10 at risk
Study: NCT00941304

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 30 at risk

Adverse event: Alveolar osteitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 31 at risk

Adverse event: Alveolar osteitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 31 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 31 at risk

Adverse event: Alveolar osteitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Alveolar osteitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk
Study: NCT00941668

Adverse event: Tooth Sensitivity to Cold
Serious: no
Organ System: General disorders
Notes: Subjects reported tooth sensitivity to cold
Frequency: 1 affected / 24 at risk

Adverse event: Oral irritation
Serious: no
Organ System: General disorders
Notes: subject reported oral irritation after using the study product
Frequency: 1 affected / 24 at risk

Adverse event: Cold and/or flu like symptoms
Serious: no
Organ System: General disorders
Notes: 2 subjects reported cold like symptoms halfway through the study and 1 subject reported flu like symptoms (Fever,chills and sore throat) at end of study.
Frequency: 1 affected / 24 at risk

Adverse event: Muscle strain
Serious: no
Organ System: General disorders
Notes: 1 subject reported a pulled muscle in their back at the end of the study
Frequency: 1 affected / 24 at risk

Adverse event: Tooth Sensitivity to Cold
Serious: no
Organ System: General disorders
Notes: Subjects reported tooth sensitivity to cold
Frequency: 2 affected / 25 at risk

Adverse event: Oral irritation
Serious: no
Organ System: General disorders
Notes: subject reported oral irritation after using the study product
Frequency: 1 affected / 25 at risk

Adverse event: Cold and/or flu like symptoms
Serious: no
Organ System: General disorders
Notes: 2 subjects reported cold like symptoms halfway through the study and 1 subject reported flu like symptoms (Fever,chills and sore throat) at end of study.
Frequency: 2 affected / 25 at risk

Adverse event: Muscle strain
Serious: no
Organ System: General disorders
Notes: 1 subject reported a pulled muscle in their back at the end of the study
Frequency: 1 affected / 25 at risk
Study: NCT00941681

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Notes: Reported as unrelated to treatment by Investigator.
Frequency: 1 affected / 11 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk
Study: NCT00941720

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Allergic reaction - Angioedemia due to ACE Inhibitors
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Blood and lymphatic system disorders - other (Relapsed disease)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 57 at risk

Adverse event: Dyspenia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Injury, poisoning and procedural complications - Other (patient fell and hit head. Never recovered)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 57 at risk

Adverse event: Laryngeal oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Colitis - diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Dyspenia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Gastrointestinal disorders - Clostridium difficile in urine and diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk
Study: NCT00941915

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: defined as Grade 3 or higher
Frequency: 1 affected / 60 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 60 at risk

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

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

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 60 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 60 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 51 affected / 60 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 30 affected / 60 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 60 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 28 affected / 60 at risk
Study: NCT00941928

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

Adverse event: vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: creatinine phosphokinase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

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

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

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

Adverse event: hemorrhage, GU
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: muscle weakness of lower limb
Frequency: 1 affected / 2 at risk
Study: NCT00941993

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 109 at risk

Adverse event: Mild Erythema at return electrode
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 109 at risk
Study: NCT00942149

Adverse event: Abnormal KUB
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pneumatocele
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: possible morgagni cdh
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: patent foramen ovale
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: unconjugated hyperbilirubinemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk
Study: NCT00942409

Adverse event: Hyponatraemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Anorexia/Early satiety
Serious: no
Organ System: General disorders
Frequency: 5 affected / 5 at risk

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

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

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

Adverse event: Flu like Syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 5 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 5 at risk

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

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 5 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 4 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 5 at risk
Study: NCT00942448

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 77 at risk

Adverse event: Gingival abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 76 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 78 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 75 at risk
Study: NCT00942604

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 100 at risk

Adverse event: Application site irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 100 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 103 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 103 at risk

Adverse event: Application site irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 103 at risk
Study: NCT00942708

Adverse event: Chest pain or tightness
Serious: yes
Organ System: Cardiac disorders
Notes: Developed chest pain during a line malfunction event (see other AE). Required hospital admission
Frequency: 1 affected / 6 at risk

Adverse event: Line malfunction
Serious: yes
Organ System: Product Issues
Notes: Patient was receiving a continuous iv medication (not a study medication) and developed a line problem. Required hospital admission and line replacement.
Frequency: 1 affected / 6 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

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

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

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

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

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

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

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

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

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk
Study: NCT00942786

Adverse event: Serious Adverse cardiac events
Serious: yes
Organ System: Cardiac disorders
Frequency: 91 affected / 297 at risk
Study: NCT00942851

Adverse event: Eyelid irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 4 subjects (2 active arm and 2 placebo arm) experience minor self-limited eyelid irritation. Ophthalmology consultation was obtained in all cases. No change in the study procedure was needed.
Frequency: 2 affected / 12 at risk

Adverse event: Eyelid irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 4 subjects (2 active arm and 2 placebo arm) experience minor self-limited eyelid irritation. Ophthalmology consultation was obtained in all cases. No change in the study procedure was needed.
Frequency: 2 affected / 12 at risk