TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01439724

Adverse event: Radiodermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Unplanned radiotherapy interruptions due to radiodermatis: Laser group = 7 patients and Placebo group = 4 patients
Frequency: 4 affected / 47 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Unplanned radiotherapy interruptions due to pneumonia
Frequency: 1 affected / 47 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unplanned chemotherapy interruptions or modification
Frequency: 5 affected / 47 at risk

Adverse event: Ear and labyrinth disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Unplanned chemotherapy interruptions or modification
Frequency: 3 affected / 47 at risk

Adverse event: Blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unplanned chemotherapy interruptions or modification
Frequency: 4 affected / 47 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Distribution of severe oral pain intensity
Frequency: 17 affected / 47 at risk

Adverse event: Radiodermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Unplanned radiotherapy interruptions due to radiodermatis: Laser group = 7 patients and Placebo group = 4 patients
Frequency: 7 affected / 47 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Unplanned radiotherapy interruptions due to pneumonia
Frequency: 1 affected / 47 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unplanned chemotherapy interruptions or modification
Frequency: 3 affected / 47 at risk

Adverse event: Ear and labyrinth disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Unplanned chemotherapy interruptions or modification
Frequency: 4 affected / 47 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Distribution of severe oral pain intensity
Frequency: 10 affected / 47 at risk
Study: NCT01439802

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 42 at risk

Adverse event: Cramping
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 17 affected / 42 at risk
Study: NCT01439815

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

Adverse event: hives (neck)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: hives (face)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk
Study: NCT01440283

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 14 at risk

Adverse event: Procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 14 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 14 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 14 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 14 at risk
Study: NCT01440387

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 41 affected / 56 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 3 affected / 56 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 56 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 56 at risk

Adverse event: Joint pain at other location
Serious: no
Organ System: General disorders
Frequency: 7 affected / 56 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 56 at risk

Adverse event: Red eyes
Serious: no
Organ System: General disorders
Frequency: 3 affected / 56 at risk

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 56 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 19 affected / 56 at risk

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

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 4 affected / 56 at risk

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

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

Adverse event: Joint pain at other location
Serious: no
Organ System: General disorders
Frequency: 3 affected / 56 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 56 at risk

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 56 at risk
Study: NCT01440517

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Diabetes Mellitus-Inadequate Control
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk
Study: NCT01440634

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk
Study: NCT01440647

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death not related to NIPPV use
Frequency: 2 affected / 16 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death not related to NIPPV use
Frequency: 3 affected / 18 at risk
Study: NCT01440881

Adverse event: Mediastinal exploration with evacuation of mediastinal and right clots/blood
Serious: no
Organ System: Surgical and medical procedures
Notes: Mediastinal exploration with evacuation of mediastinal and right clots/blood
Frequency: 1 affected / 14 at risk

Adverse event: Chest pain/ dysphagia
Serious: no
Organ System: Cardiac disorders
Notes: substernal chest pain and dysphagia
Frequency: 1 affected / 14 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Notes: Subject went to the emergency room with a complaint of Syncope. Had surgery for an aortic valve replacement.
Frequency: 1 affected / 15 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Subject was hospitalized for Atrial Fibrillation.
Frequency: 1 affected / 15 at risk

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient expired from respiratory insufficiency and failure.
Frequency: 1 affected / 15 at risk

Adverse event: Shotness of breath
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: post operative visit, admitted due to increased shortness of breath.
Frequency: 1 affected / 15 at risk
Study: NCT01440959

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 2 anorexia
Frequency: 1 affected / 30 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3 heart failure
Frequency: 1 affected / 30 at risk

Adverse event: QT prolongation
Serious: yes
Organ System: Cardiac disorders
Notes: grade 4 QT prolongation
Frequency: 1 affected / 30 at risk

Adverse event: Plumonary thromboembolism
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3 pulmonary thromboembolism
Frequency: 1 affected / 30 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 thrombocytopenia
Frequency: 2 affected / 30 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Notes: grade 2 azotemia
Frequency: 1 affected / 30 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Notes: Grade 3 cataract
Frequency: 1 affected / 30 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 30 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 30 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 30 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 30 at risk

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

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 30 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 30 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 30 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 30 at risk

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

Adverse event: Azotaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 18 affected / 30 at risk

Adverse event: Elevated aspartate aminotransferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 30 at risk

Adverse event: Elevated alanine transaminase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 30 at risk
Study: NCT01441115

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

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

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

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

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

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

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

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

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

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

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk
Study: NCT01441245

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac death
Frequency: 6 affected / 30 at risk

Adverse event: rehospitalization for all cardiovascular causes
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 30 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac death
Frequency: 3 affected / 27 at risk

Adverse event: rehospitalization for all cardiovascular causes
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 27 at risk
Study: NCT01441765

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

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

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

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

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

Adverse event: Pruritus
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

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

Adverse event: Rash (back/neck)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk
Study: NCT01441882

Adverse event: Swelling face
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3 Facial swelling
Frequency: 1 affected / 13 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 Colitis
Frequency: 1 affected / 13 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 3 Fatigue
Frequency: 2 affected / 13 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3 hypocalcemia
Frequency: 1 affected / 13 at risk

Adverse event: Oedema
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 Edema
Frequency: 1 affected / 13 at risk

Adverse event: Bilateral leg edema
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 leg edema
Frequency: 1 affected / 13 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 leukocytosis
Frequency: 1 affected / 13 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 thrombocytopenia
Frequency: 2 affected / 13 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 neutropenia
Frequency: 1 affected / 13 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 Anemia
Frequency: 2 affected / 13 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 hyperkalemia
Frequency: 1 affected / 13 at risk

Adverse event: Conjunctivitis
Serious: yes
Organ System: Eye disorders
Notes: Grade 3 conjunctivitis
Frequency: 1 affected / 13 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3 organizing pneumonia
Frequency: 1 affected / 13 at risk

Adverse event: Presyncope
Serious: yes
Organ System: General disorders
Notes: Grade 3 vasovagal reaction
Frequency: 1 affected / 13 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3 basal cell carcinoma
Frequency: 1 affected / 13 at risk
Study: NCT01442155

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 74 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 74 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 74 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 74 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 74 at risk
Study: NCT01442181

Adverse event: thrombus left appendage
Serious: yes
Organ System: Cardiac disorders
Notes: case was canceled on the OR table due to clot in left appendage
Frequency: 1 affected / 14 at risk

Adverse event: extensive pericardial adhesions
Serious: yes
Organ System: Cardiac disorders
Notes: case was canceled due to extensive pericardial adhesions
Frequency: 1 affected / 14 at risk

Adverse event: imbalance and moemory loss
Serious: no
Organ System: Nervous system disorders
Notes: Head MRI and head CT were done both normal
Frequency: 1 affected / 14 at risk

Adverse event: external cardioversion
Serious: no
Organ System: Cardiac disorders
Notes: atrial fibrillation
Frequency: 3 affected / 14 at risk

Adverse event: Wound
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: open wound incision sites, home health care with wet to dry packing
Frequency: 2 affected / 14 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: fast heart rate, medication change and patient monitored
Frequency: 1 affected / 14 at risk

Adverse event: imbalance and moemory loss
Serious: no
Organ System: Nervous system disorders
Notes: Head MRI and head CT were done both normal
Frequency: 1 affected / 11 at risk

Adverse event: Loss of consciousness
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: passed out at home was transported to ER was diagnosed with dehydration
Frequency: 1 affected / 11 at risk
Study: NCT01442363

Adverse event: rectal throbbing
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT01442675

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 831 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 831 at risk

Adverse event: Serratia infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 831 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 831 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 831 at risk

Adverse event: Benign hydatidiform mole
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 831 at risk

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 831 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 831 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 831 at risk

Adverse event: Post streptococcal glomerulonephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 831 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 831 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 494 affected / 821 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 317 affected / 822 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 242 affected / 822 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 352 affected / 822 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 102 affected / 822 at risk
Study: NCT01442688

Adverse event: Ear discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 62 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 62 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 62 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 59 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 59 at risk

Adverse event: Musculoskeletal disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 59 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Rash maculopapular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 59 at risk
Study: NCT01442779

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The deaths that occurred were complications of the disease (IPF), not related to the study drug
Frequency: 4 affected / 18 at risk
Study: NCT01443026

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Patient died four days after randomization from CAD. Patient was on placebo. Event was unrelated to study.
Frequency: 1 affected / 32 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk