TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01328366

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 143 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 143 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 143 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 143 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 143 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 143 at risk
Study: NCT01328548

Adverse event: Pre-existing fragile health and advanced age
Serious: yes
Organ System: General disorders
Notes: Non-vaccine related death
Frequency: 1 affected / 191 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Non-vaccine related death
Frequency: 1 affected / 191 at risk

Adverse event: Advanced age and medical issues (Parkinson's disease)
Serious: yes
Organ System: Nervous system disorders
Notes: Non-vaccine related death
Frequency: 1 affected / 191 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 4 affected / 191 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 3 affected / 191 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 5 affected / 191 at risk

Adverse event: Emesis/Nausea
Serious: no
Organ System: General disorders
Frequency: 5 affected / 191 at risk

Adverse event: Pain/Soreness in arm
Serious: no
Organ System: General disorders
Frequency: 3 affected / 191 at risk

Adverse event: Redness/Swelling in arm
Serious: no
Organ System: General disorders
Frequency: 4 affected / 191 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Pain/Soreness in arm
Serious: no
Organ System: General disorders
Frequency: 2 affected / 50 at risk

Adverse event: Redness/Swelling in arm
Serious: no
Organ System: General disorders
Frequency: 9 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk
Study: NCT01328717

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 78 at risk
Study: NCT01329185

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

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk
Study: NCT01329198

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: During stimulation testing, varying configurations of settings would induce different sensations - tingling, numbness, pressure, cold and warmth.
Frequency: 3 affected / 3 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: Stimulation-induced feelings of dizziness or lightheadedness
Frequency: 3 affected / 3 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Notes: Stimulation-induced pulling of the head or neck to one side or another.
Frequency: 3 affected / 3 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Notes: During stimulation testing, a sudden inability to form words.
Frequency: 1 affected / 3 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Stimulation-induced abdominal uneasiness.
Frequency: 2 affected / 3 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: During stimulation testing, varying configurations of settings would induce different sensations - tingling, numbness, pressure, cold and warmth.
Frequency: 2 affected / 2 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: Stimulation-induced feelings of dizziness or lightheadedness
Frequency: 2 affected / 2 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Notes: Stimulation-induced pulling of the head or neck to one side or another.
Frequency: 2 affected / 2 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Notes: During stimulation testing, a sudden inability to form words.
Frequency: 1 affected / 2 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 2 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Stimulation-induced abdominal uneasiness.
Frequency: 1 affected / 2 at risk
Study: NCT01329562

Adverse event: Left Side Jaw Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Feeling of Upper Body Heaviness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Flushing of Neck
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Arms Felt Warm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Abnormal Alanine Aminotransferase (ALT)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Right Leg Cramping
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

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

Adverse event: Worsening Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Right Foot Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Post bunionectomy
Frequency: 1 affected / 21 at risk

Adverse event: Jaw Tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk
Study: NCT01329939

Adverse event: Mood changes
Serious: no
Organ System: General disorders
Frequency: 3 affected / 9 at risk
Study: NCT01330017

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 109 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 108 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 107 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 112 at risk

Adverse event: Pain in jaw
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 112 at risk
Study: NCT01330030

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 57 affected / 121 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 41 affected / 121 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 121 at risk

Adverse event: Tachyphrenia
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 121 at risk

Adverse event: Lightheaded
Serious: no
Organ System: General disorders
Frequency: 20 affected / 121 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 121 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 53 affected / 122 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 43 affected / 122 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 122 at risk

Adverse event: Tachyphrenia
Serious: no
Organ System: Psychiatric disorders
Frequency: 28 affected / 122 at risk

Adverse event: Lightheaded
Serious: no
Organ System: General disorders
Frequency: 20 affected / 122 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 122 at risk
Study: NCT01330043

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 111 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 15 affected / 111 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 111 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 111 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 111 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 111 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Rapid heart rate associated with syncopal or near-syncopal event
Frequency: 1 affected / 112 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Death from lung cancer during the follow-up period
Frequency: 1 affected / 112 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Death from myocardial infection during the follow-up period
Frequency: 1 affected / 112 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 112 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 11 affected / 112 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 112 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 112 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 112 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 112 at risk
Study: NCT01330108

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 32 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: rash, not attibuted to drug
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: lower extremity edema
Serious: no
Organ System: Cardiac disorders
Notes: resolved post withdrawl of drug
Frequency: 2 affected / 32 at risk
Study: NCT01330290

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 148 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 148 at risk
Study: NCT01330303

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

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

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

Adverse event: Serum glutamic-pyruvic increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Gamma glutamyl transferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 20 at risk

Adverse event: Serum bilirubin increased (total and indirect)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk
Study: NCT01330355

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

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

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Acne infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk
Study: NCT01330433

Adverse event: Cardiac Arrest unrelated to device
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Cardiac Arrest related to complex congenital heart disease which has a 10% mortality rate.
Frequency: 1 affected / 16 at risk

Adverse event: Cardiac Arrest unrelated to device
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Cardiac Arrest related to complex congenital heart disease which has a 10% mortality rate.
Frequency: 3 affected / 19 at risk
Study: NCT01330446

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 13 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 13 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Mania
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 13 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk
Study: NCT01330459

Adverse event: Hematometra requiring reaspiration
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 61 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Uterine perforation
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 60 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk
Study: NCT01330914

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk
Study: NCT01331109

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 57 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 57 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 57 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 57 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 57 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 57 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 57 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 57 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 57 at risk

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 57 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 57 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 57 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 57 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 57 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 57 at risk
Study: NCT01331161

Adverse event: Hyponatraemia
Serious: yes
Organ System: Endocrine disorders
Notes: resulted in hospitalization- unrelated to study product
Frequency: 1 affected / 44 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Breast cancer unrelated to study product
Frequency: 1 affected / 44 at risk

Adverse event: Local Injection site reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All were attributed as related to study product- severity was between 1 and 2- all resolved
Frequency: 6 affected / 44 at risk

Adverse event: Bruise at blood draw site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: realted to phlebotomy intervention- all resolved
Frequency: 4 affected / 44 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: None related to study product- severity varied between 1 to 3 - all resolved
Frequency: 3 affected / 44 at risk

Adverse event: Bruise at blood draw site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: realted to phlebotomy intervention- all resolved
Frequency: 1 affected / 33 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: None related to study product- severity varied between 1 to 3 - all resolved
Frequency: 2 affected / 33 at risk
Study: NCT01331291

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 11 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 11 at risk

Adverse event: elevated alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 5 affected / 11 at risk

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

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 11 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 11 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 11 at risk

Adverse event: elevated aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 11 at risk

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

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 11 at risk
Study: NCT01331408

Adverse event: Lipectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 61 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 61 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: Implant site pruritus
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: Implant site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: Implant site haematoma
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: Implant site swelling
Serious: no
Organ System: General disorders
Frequency: 6 affected / 61 at risk