TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02300129

Adverse event: Erythema, papules and pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cutaneous AE related to CD07805/47 placebo gel
Frequency: 2 affected / 33 at risk

Adverse event: Erythema and skin tightness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cutaneous AE related to CD07805/47 0.5% gel
Frequency: 1 affected / 33 at risk

Adverse event: Erythema, papules and pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: AE of Special Interest related to CD07805/47 0.5% gel leading to subject discontinuation
Frequency: 1 affected / 32 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: Cutaneous AE not related to CD07805/47 0.5 gel
Frequency: 1 affected / 32 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Cutaneous AE not related to CD07805/47 0.5 gel
Frequency: 1 affected / 32 at risk

Adverse event: Erythema of eyelid
Serious: no
Organ System: Eye disorders
Notes: Cutaneous AE not related to CD07805/47 0.5 gel
Frequency: 1 affected / 32 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: Non cutaneous AE
Frequency: 1 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Non cutaneous AE
Frequency: 1 affected / 31 at risk
Study: NCT02300220

Adverse event: Oncology
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 72 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 72 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Abdominal Colic/Pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 72 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 72 at risk

Adverse event: Ankle Pain/Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 72 at risk

Adverse event: Oncology
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 72 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 72 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 72 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 72 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Abdominal Colic/Pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 72 at risk

Adverse event: Pruritis/Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 72 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 72 at risk
Study: NCT02301169

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 21 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 21 at risk
Study: NCT02301390

Adverse event: VT recurrrence
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 27 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 27 at risk

Adverse event: LV failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 27 at risk

Adverse event: Subclinical/Sub radiological ILD
Serious: yes
Organ System: Cardiac disorders
Notes: Interstitial Lung Disease (ILD)
Frequency: 1 affected / 27 at risk

Adverse event: Amiodarone induced liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hepatic enephalopathy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 27 at risk

Adverse event: Frequent loose stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Right arm ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: VT recurrrence
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 26 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Notes: Cerebrovascular accident (CVA)
Frequency: 1 affected / 26 at risk

Adverse event: Motor aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 26 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 26 at risk

Adverse event: Transient AV block while crossing the Aortic Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

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

Adverse event: right foot injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Viral Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Frequent loose stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk
Study: NCT02301403

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 315 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 315 at risk

Adverse event: Itching or Hives
Serious: no
Organ System: Immune system disorders
Frequency: 22 affected / 315 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 315 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 315 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 315 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 315 at risk

Adverse event: Hiccups
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 315 at risk

Adverse event: Persistent Indigestion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 315 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 308 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 308 at risk

Adverse event: Itching or Hives
Serious: no
Organ System: Immune system disorders
Frequency: 23 affected / 308 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 308 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 308 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 308 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 308 at risk

Adverse event: Hiccups
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 308 at risk

Adverse event: Mouth Problem
Serious: no
Organ System: General disorders
Frequency: 15 affected / 308 at risk

Adverse event: Persistent Indigestion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 308 at risk
Study: NCT02301416

Adverse event: Panniculitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 25 at risk
Study: NCT02301429

Adverse event: Cardiac vein dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Procedural pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Coronary Artery Stent Insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 13 at risk

Adverse event: Cardiac vein dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk
Study: NCT02301910

Adverse event: death of all causes
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 191 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 191 at risk

Adverse event: Repeated MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 191 at risk

Adverse event: Development heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 191 at risk

Adverse event: Major bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 191 at risk

Adverse event: death of all causes
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 191 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 191 at risk

Adverse event: Repeated MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 191 at risk

Adverse event: Development heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 191 at risk

Adverse event: Major bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 191 at risk
Study: NCT02301936

Adverse event: Sickle cell anaemia with crisis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Sickle cell anaemia with crisis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Atypical pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 9 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

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

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

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

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

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1 at risk
Study: NCT02302092

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

Adverse event: Thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk
Study: NCT02302157

Adverse event: Left Femoral Shaft Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Urinary Tract Infection (UTI)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3 at risk

Adverse event: Bilateral Decubitus Ulcers
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Escherichia Coli Urinary Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Urinary Tract Infection (UTI)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Bilateral Hip Effusions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Bilateral Pyelonephritis due to UTI
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Buttock Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 6 at risk

Adverse event: Urinary Tract Infection (UTI)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cerebrospinal Fluid Leak
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Infected Epidural Fluid
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Urinary Tract Infection (UTI)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Non-Traumatic Kidney Injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk
Study: NCT02302222

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 34 at risk

Adverse event: Post procedural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 36 at risk

Adverse event: Shock haemorrhagic
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 36 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 36 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 36 at risk

Adverse event: Post procedural haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 36 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 36 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 36 at risk
Study: NCT02302846

Adverse event: Fall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Decreased White Blood Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk
Study: NCT02302963

Adverse event: Moderate hyperglycemia, mild ketonemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 22 at risk

Adverse event: Moderate hyperglycemia, moderate ketonemia
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 22 at risk

Adverse event: Mild ketonemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 22 at risk

Adverse event: Soccer injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Respiratory illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: IV Site Bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Arm fracture from fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: outpatient surgery for spiral fracture of arm
Frequency: 1 affected / 22 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Vasovagal event
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Moderate hyperglycemia, moderate ketonemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 22 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: IV Site Bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Vasovagal event
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk
Study: NCT02303405

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Notes: Determined as not related to IP
Frequency: 1 affected / 15 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk