TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02050373

Adverse event: Need for oral tracheal intubation during hospitalization
Serious: yes
Organ System: General disorders
Notes: Need for oral tracheal intubation during hospitalization
Frequency: 3 affected / 34 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Notes: mental confusion
Frequency: 1 affected / 34 at risk

Adverse event: Need for oral tracheal intubation during hospitalization
Serious: yes
Organ System: General disorders
Notes: Need for oral tracheal intubation during hospitalization
Frequency: 7 affected / 34 at risk
Study: NCT02050841

Adverse event: Portal vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Shock haemorrhagic
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Iatrogenic injury
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 50 at risk

Adverse event: Haemorrhage coronary artery
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk
Study: NCT02051296

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: \>7/10 by self report
Frequency: 4 affected / 58 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: \>7/10 by self report
Frequency: 3 affected / 56 at risk
Study: NCT02051335

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 23 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 23 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 23 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 23 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 25 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 27 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 27 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk
Study: NCT02051686

Adverse event: Embolism venous
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 42 at risk
Study: NCT02051764

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Moderate
Frequency: 1 affected / 16 at risk
Study: NCT02052011

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk
Study: NCT02052414

Adverse event: Small bowel adhesion
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject had a laparoscopic bariatric surgery few years ago, and as a consequence subject suffered a bowel adhesion and subsequent small bowel obstruction. Subject underwent lysis of adhesion, and recovered without sequelae.
Frequency: 1 affected / 31 at risk

Adverse event: Delirium
Serious: yes
Organ System: Nervous system disorders
Notes: Subject exhibited early signs and symptoms of alzheimers symptoms. Subject was seen at ED on Friday, and admitted to neurology care for observation and work up over the weekend. \\
Frequency: 1 affected / 31 at risk

Adverse event: Extremity swelling
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: bilateral upper extremity swelling.
Frequency: 2 affected / 31 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Subjects gained weight after starting on study medication
Frequency: 2 affected / 31 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Drowsy
Frequency: 8 affected / 31 at risk

Adverse event: Dizzines
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Dizzy
Frequency: 3 affected / 31 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 31 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Mood changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 31 at risk

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

Adverse event: drymouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Drug interaction
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 31 at risk
Study: NCT02052440

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Patient developed rash 36 hours following initiation of study medication. Study medication was discontinued and rash improved and patient discharged
Frequency: 1 affected / 50 at risk
Study: NCT02052466

Adverse event: Hip fracture due to fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Treated surgically with hip hemiarthroplasty
Frequency: 2 affected / 30 at risk

Adverse event: Fracture of acromion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Minimally displaced fracture of acromion due to motor vehicle accident. Treated surgically with Open Reduction, Internal Fixation.
Frequency: 1 affected / 30 at risk

Adverse event: A-fib with rapid ventricular response
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Bladder tumor
Serious: yes
Organ System: Renal and urinary disorders
Notes: Transurethral bladder resection
Frequency: 1 affected / 30 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Lower extremity cellulitis
Frequency: 1 affected / 30 at risk

Adverse event: External artery, common femoral, and profunda endarterectomy
Serious: yes
Organ System: Vascular disorders
Notes: Peripheral vascular disease with lymphoma and claudication
Frequency: 1 affected / 30 at risk

Adverse event: Thiamine deficiency
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Altered mental state
Frequency: 1 affected / 30 at risk
Study: NCT02052635

Adverse event: Coronary artery perforation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk
Study: NCT02052661

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 132 affected / 300 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 70 affected / 300 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 29 affected / 300 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 73 affected / 300 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: General disorders
Frequency: 34 affected / 300 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 71 affected / 300 at risk
Study: NCT02052778

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 103 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 103 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 103 at risk

Adverse event: Hypertrichosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 103 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 103 at risk

Adverse event: Nail hypertrophy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Onychalgia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 103 at risk

Adverse event: Onycholysis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 103 at risk

Adverse event: Onychomadesis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 103 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 103 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 103 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 103 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 103 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 103 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 103 at risk
Study: NCT02052882

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 60 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Blood bilirubin increase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 60 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk
Study: NCT02052895

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 26 affected / 190 at risk

Adverse event: Gastrointestinal hemmorage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 190 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 190 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 190 at risk
Study: NCT02053077

Adverse event: Pneumonia and cardiac decompensation requiring treatment in intensive care unit
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 150 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: AV Block Grad 3
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Gastritis haemorrhagic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Antibiotic associated exanthema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 150 at risk

Adverse event: Insult (Posteriorinfarction after intracardiac catheter)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 150 at risk

Adverse event: Autoimmune haemolytic anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 150 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Aneurysma spurium right groin
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 150 at risk

Adverse event: Acute myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Spondylodicscitis LWS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 150 at risk
Study: NCT02053168

Adverse event: Superficial surgical site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Wound necrosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Seroma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Stomal hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Myocardial hypoxia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Abdominal wall wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 25 at risk

Adverse event: Incision site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 25 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 25 at risk
Study: NCT02053246

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

Adverse event: Fluid retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk
Study: NCT02053350

Adverse event: gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting Abdominal pain Diarrhea Nausea
Frequency: 4 affected / 7 at risk
Study: NCT02053363

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Infection
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: Venothromboembolic Event
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE)
Frequency: 2 affected / 27 at risk

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

Adverse event: Infection
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Delirium
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk
Study: NCT02053493

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Phase 1 study drug start to start of Phase 2 study drug
Frequency: 1 affected / 51 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Phase 2 study drug start to Week 15 phone call
Frequency: 1 affected / 51 at risk

Adverse event: Faecaloma
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Informed consent to start of phase 1 study drug
Frequency: 1 affected / 51 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Notes: Informed consent to start of phase 1 study drug
Frequency: 1 affected / 51 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Notes: Phase 2 study drug start to Week 15 phone call
Frequency: 1 affected / 59 at risk
Study: NCT02053766

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Mood altered
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: feeding difficulties
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 6 at risk

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

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

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

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

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

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: feeding difficulties
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk
Study: NCT02053909

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 123 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 127 at risk
Study: NCT02054104

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

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

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 10 at risk

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

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

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

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 10 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

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

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 11 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 11 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk
Study: NCT02054325

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dark pigmentation of skin after injection
Frequency: 22 affected / 43 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dark pigmentation of skin after injection
Frequency: 31 affected / 50 at risk
Study: NCT02054572

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

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

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

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

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk