TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03739203

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 250 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 250 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 250 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 250 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 250 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 250 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 250 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 250 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 250 at risk

Adverse event: Ligament sprain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 250 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 250 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 250 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 250 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 250 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 250 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 250 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 251 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 251 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 251 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 251 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 251 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 251 at risk
Study: NCT03739528

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 388 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 388 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 388 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 388 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 388 at risk
Study: NCT03739593

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Iris neovascularisation
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 5 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 5 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Device malfunction
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 5 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Visual impairment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 22 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 22 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 22 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 22 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 22 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 22 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Ocular hypertension
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 22 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 22 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 22 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 22 at risk
Study: NCT03739684

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 208 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 208 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 208 at risk
Study: NCT03739762

Adverse event: Unrelated SAE
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to study
Frequency: 1 affected / 140 at risk

Adverse event: Unrelated SAE
Serious: yes
Organ System: Eye disorders
Notes: Unrelated to Study
Frequency: 1 affected / 140 at risk

Adverse event: Unrelated SAE
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated to Study
Frequency: 1 affected / 140 at risk

Adverse event: Unrelated SAE
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to Study
Frequency: 1 affected / 140 at risk

Adverse event: Unrelated SAE
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unrelated to Study
Frequency: 2 affected / 140 at risk

Adverse event: Unrelated Other AE
Serious: no
Organ System: General disorders
Frequency: 14 affected / 140 at risk

Adverse event: Unrelated Other AE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 140 at risk

Adverse event: Anticipated Related AE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: These are expected and related to wearing the device adhered to the skin with Tegaderm (potential skin irritant)
Frequency: 9 affected / 140 at risk

Adverse event: Unrelated Other AE
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 140 at risk

Adverse event: Unrelated SAE
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to study
Frequency: 1 affected / 143 at risk

Adverse event: Unrelated SAE
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated to study
Frequency: 1 affected / 143 at risk

Adverse event: Unrelated SAE
Serious: yes
Organ System: General disorders
Notes: Unrelated to Study
Frequency: 1 affected / 143 at risk

Adverse event: Unrelated SAE
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to Study
Frequency: 1 affected / 143 at risk

Adverse event: Unrelated SAE
Serious: yes
Organ System: Surgical and medical procedures
Notes: Unrelated to Study
Frequency: 1 affected / 143 at risk

Adverse event: Unrelated SAE
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated to Study
Frequency: 1 affected / 143 at risk

Adverse event: Unrelated Other AE
Serious: no
Organ System: General disorders
Frequency: 12 affected / 143 at risk

Adverse event: Unrelated Other AE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 143 at risk

Adverse event: Anticipated Related AE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: These are expected and related to wearing the device adhered to the skin with Tegaderm (potential skin irritant)
Frequency: 1 affected / 143 at risk

Adverse event: Unrelated Other AE
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 143 at risk
Study: NCT03739983

Adverse event: Irritation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2 at risk

Adverse event: Vulvar Stinging
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2 at risk

Adverse event: Perineal Chaffing
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2 at risk
Study: NCT03740009

Adverse event: Abdominal distension
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 10 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 10 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 10 at risk

Adverse event: Heavy Menses
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 10 at risk

Adverse event: Spotting
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 10 at risk

Adverse event: Night sweats
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 10 at risk

Adverse event: Appetite Increase
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Increase in Ear Wax
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Numbness and Tingling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk
Study: NCT03740048

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 1 affected / 22 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Vascular disorders
Notes: Cerebrovascular
Frequency: 4 affected / 22 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Hyperkalemia
Frequency: 1 affected / 22 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: Vascular access infection
Frequency: 2 affected / 22 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: Infection, not related to vascular access
Frequency: 4 affected / 22 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: other
Frequency: 6 affected / 22 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 4 affected / 22 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Vascular disorders
Notes: Cerebrovascular
Frequency: 1 affected / 22 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Fluid manageme
Frequency: 6 affected / 22 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Nervous system disorders
Notes: Encephalopathy
Frequency: 5 affected / 22 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Vascular access complication, noninfectious
Frequency: 1 affected / 22 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: Infection, not related to vascular access
Frequency: 9 affected / 22 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: other
Frequency: 7 affected / 22 at risk
Study: NCT03740100

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Acute Respiratory Distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Laryngeal stenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Renal injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

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

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 8 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 8 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 8 at risk
Study: NCT03740152

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

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

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

Adverse event: Nausea/vomiting
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk
Study: NCT03740659

Adverse event: Mild Mydriasis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 41 at risk
Study: NCT03740724

Adverse event: Injection site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1 at risk
Study: NCT03740737

Adverse event: Ovarian hyperstimulation syndrome
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 525 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 525 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 278 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 150 affected / 525 at risk

Adverse event: Morning sickness (Fresh cycle)
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 28 affected / 525 at risk

Adverse event: Pelvic discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 30 affected / 525 at risk

Adverse event: Morning Sickness (Cryopreserved cycle)
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 50 affected / 278 at risk

Adverse event: Haemorrhage in pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 31 affected / 278 at risk

Adverse event: Abortion spontaneous
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 28 affected / 278 at risk

Adverse event: Biochemical pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 22 affected / 278 at risk

Adverse event: Pelvic discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 53 at risk
Study: NCT03740997

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

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

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

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Supraventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 29 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk
Study: NCT03741062

Adverse event: Inadequate Hemostasis at Donor Site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Proper hemostasis of the palatal site could not be achieved with cyanoacrylate alone, as specified in the study protocol. The palate had to be sutured and the patient was exited from the study, prior to collection of baseline information
Frequency: 1 affected / 5 at risk

Adverse event: Haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: During the first post-operative week, a hematoma formed at the recipient site of the connective tissue graft.
Frequency: 1 affected / 5 at risk
Study: NCT03742141

Adverse event: Tracheostomy
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 75 at risk

Adverse event: Transected nerve intraoperatively
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 75 at risk

Adverse event: reintubation and a tracheostomy immediately postoperatively
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 75 at risk
Study: NCT03742154

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 16 affected / 50 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 50 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Frequency: 7 affected / 50 at risk

Adverse event: Depressed mood
Serious: no
Organ System: General disorders
Frequency: 5 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 50 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Depressed mood
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 49 at risk