TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02539108

Adverse event: Linear IgA disease
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 30 at risk

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

Adverse event: Injection site Tenderness / Pain
Serious: no
Organ System: General disorders
Frequency: 21 affected / 30 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 11 affected / 30 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 30 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 30 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 30 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Injection site Tenderness / Pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 30 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 11 affected / 30 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 8 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 6 affected / 30 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 30 at risk
Study: NCT02539160

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: minor bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 38 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 38 at risk

Adverse event: minor bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 39 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 39 at risk

Adverse event: minor bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 39 at risk
Study: NCT02539511

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 23 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 17 at risk

Adverse event: Mild agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 17 at risk
Study: NCT02539823

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Tired/Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Tired/Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 13 at risk
Study: NCT02539992

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Instability
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 11 at risk

Adverse event: Mammary Carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 11 at risk

Adverse event: Flexion deficit
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 18 at risk
Study: NCT02540265

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 19 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 19 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 19 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk
Study: NCT02540330

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk
Study: NCT02540356

Adverse event: Abdominal distention (Grade 2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk

Adverse event: Hypokalemia (Grade 1)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1 at risk

Adverse event: Hypomagnesemia (Grade 1)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1 at risk

Adverse event: Right knee pain (Grade 1)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1 at risk
Study: NCT02540447

Adverse event: 3 Months Mortality
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 40 at risk

Adverse event: 30 days morbidity
Serious: no
Organ System: Surgical and medical procedures
Notes: NonLife threatening complications including infection, acute cellular rejection, vascular complications, biliary complications and IR injury
Frequency: 18 affected / 40 at risk

Adverse event: Infectious complications (30 days)
Serious: no
Organ System: Infections and infestations
Notes: Early infectious complications
Frequency: 5 affected / 40 at risk

Adverse event: Acute cellular rejection (30 Days)
Serious: no
Organ System: Immune system disorders
Frequency: 12 affected / 40 at risk

Adverse event: Ischemia/Reperfusion Injury (30 days)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Billiary complications (30 Days)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 40 at risk

Adverse event: Vascular complications (30 Days)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: 3 Months Mortality
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 40 at risk

Adverse event: 30 days morbidity
Serious: no
Organ System: Surgical and medical procedures
Notes: NonLife threatening complications including infection, acute cellular rejection, vascular complications, biliary complications and IR injury
Frequency: 15 affected / 40 at risk

Adverse event: Infectious complications (30 days)
Serious: no
Organ System: Infections and infestations
Notes: Early infectious complications
Frequency: 6 affected / 40 at risk

Adverse event: Acute cellular rejection (30 Days)
Serious: no
Organ System: Immune system disorders
Frequency: 15 affected / 40 at risk

Adverse event: Ischemia/Reperfusion Injury (30 days)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Billiary complications (30 Days)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 40 at risk

Adverse event: Vascular complications (30 Days)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk
Study: NCT02540538

Adverse event: Unsolicited symptoms
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Unsolicited symptoms
Serious: no
Organ System: General disorders
Frequency: 4 affected / 12 at risk

Adverse event: Unsolicited symptoms
Serious: no
Organ System: General disorders
Frequency: 5 affected / 10 at risk
Study: NCT02540668

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk
Study: NCT02540772

Adverse event: Worsening of confabulations
Serious: yes
Organ System: Nervous system disorders
Notes: Number of confabulations in the Dalla Barba provoked confabulation interview
Frequency: 7 affected / 10 at risk
Study: NCT02541422

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: acid reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: muscle twitches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 49 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk
Study: NCT02541591

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 52 at risk

Adverse event: EMD
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 55 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 55 at risk

Adverse event: Pulmonary congestion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: serious hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk
Study: NCT02541864

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patients had Nausea discomforts.
Frequency: 75 affected / 164 at risk

Adverse event: Dizziness
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patients had dizziness discomforts.
Frequency: 17 affected / 164 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patients had Nausea discomforts.
Frequency: 12 affected / 166 at risk

Adverse event: Dizziness
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patients had dizziness discomforts.
Frequency: 7 affected / 166 at risk
Study: NCT02541903

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 2 fatigue requiring hospitalization
Frequency: 1 affected / 8 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Patient died on C1D1 before starting treatment
Frequency: 1 affected / 8 at risk

Adverse event: Deep Venous Thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3
Frequency: 1 affected / 8 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: Was admitted to the hospital for new drainage from L inguinal mass on 8/12/2017 , treated with Vanco/Zosyn and hyration. was given diaudid and norco for pain PRN. was discharged home on 8/15/2017
Frequency: 1 affected / 8 at risk

Adverse event: Decreased platelet count
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Pain in scrotal region
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Anaemia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk
Study: NCT02542150

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 12 at risk
Study: NCT02542397

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 75 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 75 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 75 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 75 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 75 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 75 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 75 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 75 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: General disorders and administration site conditions - Other, Weakness in joints
Serious: no
Organ System: General disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 75 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 75 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Injury, poisoning and procedural complications - Other, Chin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 75 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 75 at risk

Adverse event: Nervous system disorders - Other, Change in mental status
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 75 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 75 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 75 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 75 at risk
Study: NCT02542410

Adverse event: IRREGULAR VAGINAL BLEEDING
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 4 at risk

Adverse event: Nausea
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: IRREGULAR VAGINAL BLEEDING
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 5 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk
Study: NCT02542462

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: Axillary temperature equal or greater to 99.5 Fahrenheit
Frequency: 4 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Three looser than normal stools a day
Frequency: 3 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: One episode of vomiting
Frequency: 8 affected / 25 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Notes: Crying more than usual
Frequency: 17 affected / 25 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: Axillary temperature equal or greater to 99.5 Fahrenheit
Frequency: 1 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Three looser than normal stools a day
Frequency: 3 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: One episode of vomiting
Frequency: 7 affected / 25 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Notes: Crying more than usual
Frequency: 15 affected / 25 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: Axillary temperature equal or greater to 99.5 Fahrenheit
Frequency: 6 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Three looser than normal stools a day
Frequency: 3 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: One episode of vomiting
Frequency: 5 affected / 25 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Notes: Crying more than usual
Frequency: 13 affected / 25 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: Axillary temperature equal or greater to 99.5 Fahrenheit
Frequency: 1 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Three looser than normal stools a day
Frequency: 2 affected / 26 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: One episode of vomiting
Frequency: 8 affected / 26 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Notes: Crying more than usual
Frequency: 16 affected / 26 at risk