TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02000596

Adverse event: muscle aches or neck aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1
Frequency: 1 affected / 2 at risk

Adverse event: smell aversion
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 1 affected / 2 at risk

Adverse event: elevated AST
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 2 affected / 2 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 2 at risk

Adverse event: Paresthia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 1 affected / 2 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 1 affected / 2 at risk

Adverse event: elevated AST
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1
Frequency: 1 affected / 2 at risk

Adverse event: elevated ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 1 affected / 2 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 1 affected / 2 at risk

Adverse event: Reflux
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 2 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2
Frequency: 1 affected / 2 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 1 affected / 2 at risk

Adverse event: Taste Changes
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 2 at risk
Study: NCT02000908

Adverse event: Thermal burn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk
Study: NCT02000921

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Difficulty concentrating
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 53 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonia
Frequency: 1 affected / 56 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 56 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 56 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 56 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 56 at risk
Study: NCT02001714

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 232 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 232 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 231 at risk
Study: NCT02001974

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4 at risk

Adverse event: Metastasis to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

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

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

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

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Intracranial hypotension
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Oesophageal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 23 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 23 at risk
Study: NCT02002091

Adverse event: Atherothrombotic event
Serious: yes
Organ System: Vascular disorders
Notes: Acute coronary syndrome Lower-limb acute arterial thrombosis Acute cerebrovascular event
Frequency: 3 affected / 109 at risk

Adverse event: Moderate acute renal insufficiency
Serious: no
Organ System: Renal and urinary disorders
Notes: Rise of creatinine from the baseline, \> 1.5 x or Glomerular filtration rate \< 60 ml/min/1,73m²
Frequency: 3 affected / 109 at risk

Adverse event: New onset of permanent hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 109 at risk

Adverse event: Atherothrombotic event
Serious: yes
Organ System: Vascular disorders
Notes: Acute coronary syndrome Lower-limb acute arterial thrombosis Acute cerebrovascular event
Frequency: 4 affected / 191 at risk

Adverse event: Moderate acute renal insufficiency
Serious: no
Organ System: Renal and urinary disorders
Notes: Rise of creatinine from the baseline, \> 1.5 x or Glomerular filtration rate \< 60 ml/min/1,73m²
Frequency: 4 affected / 191 at risk

Adverse event: New onset of permanent hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 191 at risk
Study: NCT02002221

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 78 at risk

Adverse event: Squamous cell carcinoma of the tongue
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 78 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 78 at risk

Adverse event: Hunger
Serious: no
Organ System: General disorders
Frequency: 7 affected / 78 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 78 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 78 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 78 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 78 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 78 at risk

Adverse event: Hunger
Serious: no
Organ System: General disorders
Frequency: 3 affected / 78 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 78 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 78 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 78 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 78 at risk
Study: NCT02002533

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 37 at risk

Adverse event: mucositis stomastitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 37 at risk
Study: NCT02002650

Adverse event: Moderate to severe bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Moderate to severe bleeding was defined as clinically significant bleeding with hemoglobin level drop ≥3g with the need for transfusion, angiographic intervention or surgery.
Frequency: 8 affected / 1297 at risk

Adverse event: Moderate to severe biliary infection
Serious: yes
Organ System: Infections and infestations
Notes: Febrile or septic illness requiring \>3 d of hospital treatment or need endoscopic or percutaneous intervention.

Septic shock or surgery.
Frequency: 7 affected / 1297 at risk

Adverse event: Mild bleeding
Serious: no
Organ System: Gastrointestinal disorders
Notes: Clinical evidence of bleeding (ie, not just endoscopic); Hb level drop \<3 g; no need for transfusion.
Frequency: 5 affected / 1297 at risk

Adverse event: Mild biliary infection
Serious: no
Organ System: Infections and infestations
Notes: Mild biliary infection was defined as a temperature of more than 38°C for 24-48 h after the procedure, thought to have a biliary cause (colicky pain and cholestasis/jaundice) without evidence of other concomitant infections.
Frequency: 15 affected / 1297 at risk

Adverse event: Mild perforation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Possible, or only very slight leak of fluid or contrast dye; treatable by fluids and suction for ≤3d
Frequency: 1 affected / 1297 at risk

Adverse event: Pulmonary infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1297 at risk

Adverse event: Incomplete bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1297 at risk

Adverse event: Moderate to severe bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Moderate to severe bleeding was defined as clinically significant bleeding with hemoglobin level drop ≥3g with the need for transfusion, angiographic intervention or surgery.
Frequency: 6 affected / 1303 at risk

Adverse event: Moderate to severe biliary infection
Serious: yes
Organ System: Infections and infestations
Notes: Febrile or septic illness requiring \>3 d of hospital treatment or need endoscopic or percutaneous intervention.

Septic shock or surgery.
Frequency: 9 affected / 1303 at risk

Adverse event: Mild bleeding
Serious: no
Organ System: Gastrointestinal disorders
Notes: Clinical evidence of bleeding (ie, not just endoscopic); Hb level drop \<3 g; no need for transfusion.
Frequency: 4 affected / 1303 at risk

Adverse event: Mild biliary infection
Serious: no
Organ System: Infections and infestations
Notes: Mild biliary infection was defined as a temperature of more than 38°C for 24-48 h after the procedure, thought to have a biliary cause (colicky pain and cholestasis/jaundice) without evidence of other concomitant infections.
Frequency: 24 affected / 1303 at risk

Adverse event: Pulmonary infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1303 at risk
Study: NCT02002767

Adverse event: Vessel puncture site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk
Study: NCT02002819

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 34 at risk

Adverse event: Fatigue
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 34 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 34 at risk
Study: NCT02002936

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

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

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

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

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

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

Adverse event: Periodontitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1 at risk
Study: NCT02003014

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 880 at risk

Adverse event: Bile duct cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 880 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 880 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 880 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 880 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 880 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 880 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 880 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 880 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 880 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 880 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 880 at risk

Adverse event: Primary biliary cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 880 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 20 affected / 880 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 880 at risk
Study: NCT02003365

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Frostbite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Food poisoning
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Temporomandibular pain and dysfunction syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk
Study: NCT02003391

Adverse event: Blepharal pigmentation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 81 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 81 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 81 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 81 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 81 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 81 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 81 at risk

Adverse event: Eyelids pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 81 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 81 at risk

Adverse event: Ocular surface disease
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 81 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 81 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 81 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 75 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Ocular surface disease
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 75 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 75 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Dry throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Nasal dryness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 75 at risk
Study: NCT02003534

Adverse event: Conjunctiva Hyperemia
Serious: no
Organ System: Eye disorders
Frequency: 24 affected / 372 at risk
Study: NCT02003638

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Notes: At week 11, hospitalized for abdominal discomfort, nausea, chest pain. Vital signs, serial ECG, cardiac enzymes, chest radiography, and hemoglobin were normal. His symptoms resolved spontaneously within 24 hours without cessation of study drug.
Frequency: 1 affected / 5 at risk

Adverse event: Rocky mountain spotted fever
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Bacterial pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Asymptomatic. Incidental finding of chronic pulmonary emboli on baseline CT
Frequency: 1 affected / 5 at risk