TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00718081

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

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

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 29 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 29 at risk

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

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: All adverse events in this table were assessed by the PI as possibly or probably related to study drug
Frequency: 1 affected / 29 at risk

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

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 29 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 29 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

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

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

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

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: All adverse events in this table were assessed by the PI as possibly or probably related to study drug
Frequency: 2 affected / 30 at risk

Adverse event: Hypothermia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk
Study: NCT00718094

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk
Study: NCT00718120

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 55 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 14 affected / 55 at risk

Adverse event: Joint pain at other location
Serious: no
Organ System: General disorders
Frequency: 5 affected / 55 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 19 affected / 55 at risk

Adverse event: Red eyes
Serious: no
Organ System: General disorders
Frequency: 3 affected / 55 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 55 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Frequency: 36 affected / 55 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 4 affected / 55 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 55 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 55 at risk

Adverse event: Joint pain at other location
Serious: no
Organ System: General disorders
Frequency: 6 affected / 55 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 11 affected / 55 at risk

Adverse event: Red eyes
Serious: no
Organ System: General disorders
Frequency: 4 affected / 55 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 55 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Frequency: 13 affected / 55 at risk
Study: NCT00718302

Adverse event: SUBJECT EXPIRED DUE TO CANCER
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 119 at risk

Adverse event: PAINFUL IMPLANT-SCREW,PLATE
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 119 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 119 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 119 at risk

Adverse event: Developed Equinous Contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Non-Union
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 114 at risk

Adverse event: PAINFUL IMPLANT-SCREW,PLATE
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 114 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 114 at risk

Adverse event: Necrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 114 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 114 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Loosening Hardware
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 114 at risk
Study: NCT00718666

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 36 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 10 affected / 36 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 8 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 36 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 38 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 21 affected / 45 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 15 affected / 45 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 9 affected / 45 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 45 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 5 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 45 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 46 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 100 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 46 affected / 89 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 22 affected / 89 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 21 affected / 89 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 89 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 7 affected / 89 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 89 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 89 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 100 at risk
Study: NCT00718770

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 10 at risk
Study: NCT00718887

Adverse event: Drug hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 89 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 89 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 89 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 77 at risk
Study: NCT00719134

Adverse event: Chest discomfort
Serious: no
Organ System: Nervous system disorders
Notes: Expected medication side effect
Frequency: 6 affected / 66 at risk

Adverse event: Heart palpitation
Serious: no
Organ System: Nervous system disorders
Notes: Expected medication side effect
Frequency: 4 affected / 66 at risk

Adverse event: Throat tightness
Serious: no
Organ System: Nervous system disorders
Notes: Expected medication side effect
Frequency: 7 affected / 66 at risk

Adverse event: Skin sensitivity
Serious: no
Organ System: Nervous system disorders
Notes: Expected medication side effect
Frequency: 6 affected / 66 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Nervous system disorders
Notes: Expected medication side effect
Frequency: 8 affected / 66 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Expected medication side effect
Frequency: 9 affected / 66 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Nervous system disorders
Notes: Expected medication side effect
Frequency: 5 affected / 66 at risk

Adverse event: Heart palpitation
Serious: no
Organ System: Nervous system disorders
Notes: Expected medication side effect
Frequency: 6 affected / 66 at risk

Adverse event: Throat tightness
Serious: no
Organ System: Nervous system disorders
Notes: Expected medication side effect
Frequency: 4 affected / 66 at risk

Adverse event: Skin sensitivity
Serious: no
Organ System: Nervous system disorders
Notes: Expected medication side effect
Frequency: 3 affected / 66 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Nervous system disorders
Notes: Expected medication side effect
Frequency: 3 affected / 66 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Expected medication side effect
Frequency: 1 affected / 66 at risk
Study: NCT00719355

Adverse event: Hospitalization respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes hospitalizations for pnemonia and upper respiratory tract infections.
Frequency: 2 affected / 51 at risk

Adverse event: Hospitalization cardiac related
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 51 at risk

Adverse event: Fall
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 52 at risk

Adverse event: Death
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hospitalization respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes hospitalizations for pnemonia and upper respiratory tract infections.
Frequency: 1 affected / 52 at risk

Adverse event: Hospitalization renal disease
Serious: yes
Organ System: Renal and urinary disorders
Notes: Patient hospitalized for acute renal failure.
Frequency: 1 affected / 52 at risk

Adverse event: Hospitalization cardiac related
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hospitalization bowel obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hospitalization low blood sugar
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 52 at risk

Adverse event: Fall
Serious: no
Organ System: Social circumstances
Frequency: 3 affected / 51 at risk
Study: NCT00719732

Adverse event: Chronic inflammation/iritis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 196 at risk
Study: NCT00719862

Adverse event: Dysgusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 242 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 242 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 242 at risk

Adverse event: Dysgusia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 238 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 238 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 238 at risk
Study: NCT00719953

Adverse event: Dirarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Two patients were affected, only one event was defined as probably related.
Frequency: 2 affected / 30 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Three patients were affected, two of them had a history of hypertension, and theirs events were defined as not related.
Frequency: 3 affected / 30 at risk
Study: NCT00720057

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 153 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 153 at risk

Adverse event: Tooth socket haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 153 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: Abscess oral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 153 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 153 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 153 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 159 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 159 at risk

Adverse event: Visual field defect
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 159 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 159 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Tooth socket haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 159 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 159 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 159 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 159 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 159 at risk
Study: NCT00720226

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 54 at risk

Adverse event: Worsening of respiratory symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 54 at risk

Adverse event: Worsening of gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 54 at risk

Adverse event: Worsening of musculoskeletal symptoms or fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 54 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 52 at risk

Adverse event: Worsening of respiratory symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 52 at risk

Adverse event: Worsening of gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 52 at risk

Adverse event: Worsening of musculoskeletal symptoms or fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 52 at risk
Study: NCT00720278

Adverse event: Exposure in utero
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 178 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 178 at risk

Adverse event: Dysgesusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 178 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 178 at risk

Adverse event: Dysgesusia
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 170 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 170 at risk

Adverse event: Dysgesusia
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 178 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 178 at risk
Study: NCT00720369

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: persistence of pre-existing atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject admitted to ER with chest pain, diagnosed with pneumonia, deemed to be unrelated to study participation by PI.
Frequency: 1 affected / 8 at risk

Adverse event: discomfort in MRI
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk
Study: NCT00720473

Adverse event: Loss of consciousness
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Subject fell off bicycle and lost consciousness.
Frequency: 1 affected / 45 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Notes: Subject was hospitalized due to mania
Frequency: 1 affected / 45 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject developed a rash, which was found to be unrelated by the subject's dermatologist.
Frequency: 1 affected / 45 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject developed a rash after taking second dose.
Frequency: 1 affected / 45 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject reported developing a blister on the hand.
Frequency: 1 affected / 45 at risk

Adverse event: Mania
Serious: no
Organ System: Psychiatric disorders
Notes: Subject entered a manic state, with decreased sleep, pressured speech, and delusions.
Frequency: 1 affected / 45 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Subject reported blurry vision
Frequency: 1 affected / 45 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Four subjects reported sleep disturbances.
Frequency: 4 affected / 45 at risk

Adverse event: Decreased balance
Serious: no
Organ System: General disorders
Notes: Three subjects reported feeling unbalanced or dizzy.
Frequency: 3 affected / 45 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Two subject reported gastrointestinal problems including upset stomach and indigestion.
Frequency: 2 affected / 45 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: One subject experienced increased irritability
Frequency: 1 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Two subjects reported mild headaches.
Frequency: 2 affected / 45 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One subject reported a mild runny nose.
Frequency: 1 affected / 45 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A subject reported gaining one pound.
Frequency: 1 affected / 45 at risk