TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00214136

Adverse event: Acute GI Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 25 at risk

Adverse event: Acute GI Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 25 at risk

Adverse event: Late GI Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: Late GI Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Acute GU Grade 1
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 25 at risk

Adverse event: Acute GU Grade 2
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 25 at risk

Adverse event: Late GU Grade 1
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 25 at risk

Adverse event: Late GU Grade 2
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 25 at risk

Adverse event: Late GU Grade 3
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk
Study: NCT00214786

Adverse event: Elevated Liver Function Tests
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Three patients had elevated liver function tests post transplant and 1 patient had gallbladder hemorrhage.
Frequency: 4 affected / 4 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient experienced N \& V which the PI determined was related to the protocol stated immunosuppressive medications.
Frequency: 1 affected / 4 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 4 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4 at risk
Study: NCT00216320

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: began experiencing symptoms, went to ER and was admitted for an acute MI. Patient was discharged from the hospital and scheduled for heart surgery to remove blockage. However he then passed away suddenly, before the surgery was done
Frequency: 1 affected / 43 at risk

Adverse event: Skin Irritation electrodes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Irritation from electrodes used with WalkAide
Frequency: 4 affected / 43 at risk

Adverse event: Skin irritation AFO
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: tripped and fell
Frequency: 2 affected / 43 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: sprained ankle getting out of bed
Frequency: 1 affected / 43 at risk

Adverse event: Loss of consciousness
Serious: no
Organ System: General disorders
Notes: Pt lost consciousness in Physical Therapy, no reason was reported
Frequency: 1 affected / 43 at risk

Adverse event: LE swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject complained of swelling not previously noted
Frequency: 1 affected / 43 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pt fell and fractured wrist. Subject was in teh AFO phase of Arm @ but was not wearing a study device at the time
Frequency: 1 affected / 39 at risk

Adverse event: Skin Irritation electrodes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Irritation from electrodes used with WalkAide
Frequency: 3 affected / 39 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: tripped and fell
Frequency: 2 affected / 39 at risk

Adverse event: weakness and fatigue
Serious: no
Organ System: General disorders
Notes: Subject was weak and fatigued, required bedrest
Frequency: 1 affected / 39 at risk

Adverse event: Heart surgery
Serious: yes
Organ System: Cardiac disorders
Notes: Had emergency heart surgery 9/15/06
Frequency: 1 affected / 30 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: tripped and fell
Frequency: 1 affected / 30 at risk

Adverse event: Sinus condition
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: subject missed visit due to sinus infection
Frequency: 1 affected / 30 at risk

Adverse event: Shoulder surgery
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject had surgery for rotator cuff tear
Frequency: 1 affected / 30 at risk
Study: NCT00216736

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

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 31 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: transient tingling in arms or feet
Frequency: 2 affected / 31 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk
Study: NCT00217087

Adverse event: heart attack resulting in death
Serious: yes
Organ System: Cardiac disorders
Notes: not related to study participation
Frequency: 1 affected / 36 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: known/anticipated risk - post endoscopic mucosal resection - treated endoscopically or observation only
Frequency: 1 affected / 36 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Notes: required hospitalization with IV fluids both incidents were unrelated to study participation
Frequency: 1 affected / 36 at risk

Adverse event: Atrial fibrilation
Serious: no
Organ System: Cardiac disorders
Notes: not related to study participation
Frequency: 1 affected / 36 at risk

Adverse event: Renal failure - Sepsis
Serious: yes
Organ System: Renal and urinary disorders
Notes: unrelated to study participation
Frequency: 1 affected / 37 at risk

Adverse event: Respitory Failure / Sepsis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unrelated to study participation
Frequency: 1 affected / 37 at risk

Adverse event: heart attack resulting in death
Serious: yes
Organ System: Cardiac disorders
Notes: not related to study participation
Frequency: 2 affected / 37 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: known/anticipated risk - post endoscopic mucosal resection - treated endoscopically or observation only
Frequency: 1 affected / 37 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Notes: required hospitalization with IV fluids both incidents were unrelated to study participation
Frequency: 1 affected / 37 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: known and anticipated risk of Photodynamic therapy (Photofrin)
Frequency: 12 affected / 37 at risk

Adverse event: Pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participant had pain last longer than is anticipated after photodynamic therapy, treated with medication
Frequency: 1 affected / 37 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: known and anticipated event post photodynamic therapy
Frequency: 6 affected / 37 at risk
Study: NCT00217399

Adverse event: hand-foot syndome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 35 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 35 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 35 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 35 at risk

Adverse event: anthralgias
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 35 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 35 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 35 at risk

Adverse event: elevated liver function tests
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 35 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 23 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 35 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 35 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 35 at risk

Adverse event: joint function
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 35 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 8 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 35 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 35 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 35 at risk

Adverse event: rigors/chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 35 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk
Study: NCT00217438

Adverse event: Mucositis-Grade 3 or higher
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 66 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mucositis recorded separately.
Frequency: 7 affected / 66 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mucositis recorded separately
Frequency: 7 affected / 66 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Graft versus host disease of the gut
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Mucositis-Grade 3 or higher
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 64 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mucositis recorded separately.
Frequency: 3 affected / 64 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mucositis recorded separately
Frequency: 2 affected / 64 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk
Study: NCT00217581

Adverse event: Neutrophil count
Serious: yes
Organ System: Investigations
Frequency: 13 affected / 39 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 39 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 39 at risk

Adverse event: Late Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 39 at risk

Adverse event: Gastrointestinal (GI) Perforation (not graded)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 39 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Acute Neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 39 at risk

Adverse event: White Blood Count (WBC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 39 at risk

Adverse event: Late Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 39 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 39 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 39 at risk

Adverse event: Acute Neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 39 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 39 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Frequency: 2 affected / 39 at risk

Adverse event: Hemoglobin (HGB)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 39 at risk

Adverse event: Chronic Neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 39 at risk
Study: NCT00217971

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Notes: One patient required hospitalization for worsening diabetes after study completion during the follow-up period.
Frequency: 1 affected / 79 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: One patient was involved in an altercation with the police resulting in a hospitalization with eventual discharge.
Frequency: 1 affected / 79 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The fourth patient had a stomach virus and was hospitalized for dehydration and was released after several days.
Frequency: 1 affected / 79 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 79 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 79 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 79 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One patient had worsening of chronic asthma that was previously well-controlled, resulting in a brief hospitalization.
Frequency: 1 affected / 77 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 77 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 77 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 77 at risk
Study: NCT00218023

Adverse event: routine liver-function tests showed an increase from baseline in hepatic enzyme values
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 22 at risk

Adverse event: eye injury (torn conjunctiva)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

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

Adverse event: suicidal tendencies
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 25 at risk

Adverse event: work-related traumatic injury to finger that required surgical repair
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk
Study: NCT00218062

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Migraine
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Change in electrocardiogram (EKG)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk
Study: NCT00218257

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 38 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea, vomiting, and diarrhea
Frequency: 7 affected / 38 at risk
Study: NCT00218296

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 19 affected / 97 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 4 affected / 97 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 97 at risk

Adverse event: Muscle Aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 97 at risk

Adverse event: Redness at Patch Site
Serious: no
Organ System: General disorders
Frequency: 8 affected / 97 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 97 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 3 affected / 102 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 9 affected / 102 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 13 affected / 102 at risk
Study: NCT00218426

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 102 at risk

Adverse event: local site reaction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 102 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 102 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 102 at risk

Adverse event: increased liver enzyme
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 102 at risk

Adverse event: local site reaction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 102 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 102 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 102 at risk

Adverse event: local site reaction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 102 at risk
Study: NCT00218439

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Gastrointenstinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 62 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 10 affected / 62 at risk

Adverse event: sexual side effects
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 62 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 62 at risk

Adverse event: dry mouth / taste changes
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: change in appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 62 at risk

Adverse event: unusual dreams
Serious: no
Organ System: General disorders
Frequency: 5 affected / 62 at risk

Adverse event: anxiety / irritability
Serious: no
Organ System: General disorders
Frequency: 8 affected / 62 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 62 at risk

Adverse event: Gastrointenstinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 62 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 16 affected / 62 at risk

Adverse event: sexual side effects
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 62 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 62 at risk

Adverse event: dry mouth / taste changes
Serious: no
Organ System: General disorders
Frequency: 6 affected / 62 at risk

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

Adverse event: change in appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 62 at risk

Adverse event: anxiety / irritability
Serious: no
Organ System: General disorders
Frequency: 3 affected / 62 at risk