TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02046369

Adverse event: Bipolar I disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 175 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 175 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 175 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 175 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 175 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 175 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 175 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 175 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 175 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 175 at risk

Adverse event: Bipolar I disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 172 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 172 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 172 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 172 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 172 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 172 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 172 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 172 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 172 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 172 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 172 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 172 at risk
Study: NCT02046525

Adverse event: H. pylori infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk
Study: NCT02046616

Adverse event: Acute psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 133 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 133 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 133 at risk

Adverse event: Infectious pleural effusion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 133 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 133 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 133 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 133 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 133 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 133 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 133 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 133 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 133 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 133 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 133 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 133 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 133 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 133 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 133 at risk
Study: NCT02046772

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 33 at risk

Adverse event: Nausea or Vomits
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk
Study: NCT02047032

Adverse event: stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 250 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 19 affected / 250 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 250 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 250 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 250 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 250 at risk

Adverse event: facial edema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Subcutaneous haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 250 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 250 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 62 affected / 250 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 250 at risk

Adverse event: stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 250 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 250 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 250 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 10 affected / 250 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 250 at risk

Adverse event: Hypogeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 250 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 250 at risk

Adverse event: Back pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 250 at risk

Adverse event: Pruritus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 250 at risk

Adverse event: Dysuria
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 250 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 250 at risk
Study: NCT02047253

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 28 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 28 at risk
Study: NCT02047305

Adverse event: Mucosal Lacerations
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 96 at risk

Adverse event: Mucosal Bleb
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 96 at risk

Adverse event: Stricture
Serious: no
Organ System: Surgical and medical procedures
Frequency: 20 affected / 96 at risk
Study: NCT02047643

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 18 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 18 at risk
Study: NCT02047747

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

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

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

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

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

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

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

Adverse event: elevated ALT
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: elevated AST
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

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

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

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

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

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

Adverse event: jaw trismus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: increased creatinine
Serious: no
Organ System: Renal and urinary 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: dry skin/cracking (fingertips/nail bed)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk
Study: NCT02047981

Adverse event: Suspected ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 97047 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 97047 at risk

Adverse event: Coma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 97047 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 97047 at risk

Adverse event: N/A
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 97047 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3262 affected / 97047 at risk

Adverse event: Suspected dehydration
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 93191 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 93191 at risk

Adverse event: ARI
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 93191 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93191 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3392 affected / 93191 at risk
Study: NCT02048072

Adverse event: AV-Block Mobitz II / AV-Block III°
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: worsening of neuropsychological symptoms
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: exacerbation of migraines
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk
Study: NCT02048241

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk
Study: NCT02049437

Adverse event: Severe neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: ANC\<500
Frequency: 1 affected / 33 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Radius fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 33 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hidradentitis Suppurativa
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Abnormal blood test
Serious: no
Organ System: General disorders
Frequency: 21 affected / 33 at risk

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

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Ankle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 32 at risk

Adverse event: Acute gout flare
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

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

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

Adverse event: Abnormal blood test
Serious: no
Organ System: General disorders
Frequency: 15 affected / 32 at risk
Study: NCT02049476

Adverse event: Cataract progression
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 20 at risk

Adverse event: Ocular hypertension
Serious: no
Organ System: Eye disorders
Notes: Intraocular pressure (IOP) of 25 mmHg or higher on any visit
Frequency: 7 affected / 20 at risk

Adverse event: Cataract surgery
Serious: no
Organ System: Eye disorders
Notes: progression of a cataract that required surgery
Frequency: 2 affected / 20 at risk
Study: NCT02049502

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Increase in stool frequency
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk
Study: NCT02049814

Adverse event: Sudden hearing loss
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 248 at risk

Adverse event: Abnormal liver function test
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 248 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 248 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 248 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 248 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 245 at risk

Adverse event: Cerebral haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 245 at risk

Adverse event: Hepatic tumor
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 245 at risk

Adverse event: Swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 245 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 245 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 245 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 245 at risk
Study: NCT02049866

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Nonvertebral fragility fracture
Frequency: 3 affected / 33 at risk

Adverse event: Erythema
Serious: no
Organ System: Surgical and medical procedures
Notes: Redness at injection site reaction
Frequency: 2 affected / 33 at risk

Adverse event: Pain
Serious: no
Organ System: Surgical and medical procedures
Notes: Injection site reaction
Frequency: 9 affected / 33 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 33 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 33 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 33 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 33 at risk

Adverse event: Numbness and/or tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 33 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Pain in thighs, hips, or groin
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 33 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 33 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Low Energy
Serious: no
Organ System: General disorders
Frequency: 4 affected / 33 at risk
Study: NCT02049931

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk
Study: NCT02049983

Adverse event: hematoma (sub capsular)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

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

Adverse event: extrahepatic biloma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: petechiae, internal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 50 at risk

Adverse event: petechiae, external
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk
Study: NCT02050048

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Due to pre-existing condition
Frequency: 1 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 14 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Lactic acidosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 12 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 12 at risk
Study: NCT02050321

Adverse event: Respiatory Infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Elevated Liver Values
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2 at risk
Study: NCT02050334

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: urinary tract infections
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: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 9 at risk

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