TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03575754

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

Adverse event: Abdominal wall abscess
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Mild Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Local Stomal Site Infection
Serious: no
Organ System: Infections and infestations
Notes: Infection seeded at the site of the gastrostomy tube tract
Frequency: 2 affected / 25 at risk

Adverse event: Gastrostomy Tube Failure
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrostomy tube failure requiring non-invasive or surgical intervention to replace
Frequency: 5 affected / 25 at risk

Adverse event: Mild Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk
Study: NCT03575806

Adverse event: Hepatic pain
Serious: no
Organ System: Hepatobiliary disorders
Notes: Patients with total bilirubin or ALT or AST elevation
Frequency: 19 affected / 25 at risk

Adverse event: Bone marrow failure
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: patients with decreasing white blood cells or lymphocytes
Frequency: 9 affected / 25 at risk

Adverse event: Hepatic pain
Serious: no
Organ System: Hepatobiliary disorders
Notes: Patients with total bilirubin or ALT or AST elevation
Frequency: 9 affected / 26 at risk
Study: NCT03575962

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

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

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

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

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 14 at risk
Study: NCT03576144

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

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

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

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

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

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

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

Adverse event: Oral mucosal erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

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

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk
Study: NCT03576716

Adverse event: Sensation in arm during infusion
Serious: no
Organ System: General disorders
Frequency: 5 affected / 18 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk
Study: NCT03576768

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: Migraine headache
Frequency: 1 affected / 12 at risk
Study: NCT03576885

Adverse event: IVH
Serious: yes
Organ System: Nervous system disorders
Notes: Intraventricular Hemorrhage
Frequency: 2 affected / 16 at risk

Adverse event: MetHb% >2
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Methemoglobinemia
Frequency: 3 affected / 16 at risk

Adverse event: Culture positive sepsis
Serious: no
Organ System: Infections and infestations
Notes: Culture proven sepsis treated with antibiotics
Frequency: 5 affected / 16 at risk

Adverse event: PDA requiring treatment
Serious: no
Organ System: Cardiac disorders
Notes: Patent ductus arteriosus requiring medical or surgical treatment
Frequency: 3 affected / 16 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Notes: Left ventricular dysfunction or EF less than 40%
Frequency: 1 affected / 16 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Neonatal Jaundice treated by Phototherapy
Frequency: 7 affected / 16 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Platelets less than 100,000
Frequency: 1 affected / 16 at risk

Adverse event: IVH
Serious: yes
Organ System: Nervous system disorders
Notes: Intraventricular Hemorrhage
Frequency: 2 affected / 16 at risk

Adverse event: NEC
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Necrotizing Enterocolitis
Frequency: 3 affected / 16 at risk

Adverse event: MetHb% >2
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Methemoglobinemia
Frequency: 5 affected / 16 at risk

Adverse event: Culture positive sepsis
Serious: no
Organ System: Infections and infestations
Notes: Culture proven sepsis treated with antibiotics
Frequency: 9 affected / 16 at risk

Adverse event: PDA requiring treatment
Serious: no
Organ System: Cardiac disorders
Notes: Patent ductus arteriosus requiring medical or surgical treatment
Frequency: 4 affected / 16 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Notes: Left ventricular dysfunction or EF less than 40%
Frequency: 1 affected / 16 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Neonatal Jaundice treated by Phototherapy
Frequency: 7 affected / 16 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Platelets less than 100,000
Frequency: 3 affected / 16 at risk
Study: NCT03577106

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: One participant experienced having a kidney stone during the course of their TMS treatment within the study. They were hospitalized for this, and missed the final TMS session. This was not related to study intervention but was unanticipated.
Frequency: 1 affected / 24 at risk

Adverse event: Jaw clenching/Teeth Rattling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The stimulation from the TMS coil can also activate the jaw muscles, which can result in participants clenching their jaw or having their teeth rattle. This event was expected, and was mediated with putting gauze in participant's mouths beforehand.
Frequency: 20 affected / 24 at risk

Adverse event: Tapping Sensation on Scalp/Eye or Cheek Twitch
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Activation of the neurons within the brain via the TMS coil also creates a tapping sensation on the scalp for the person receiving treatment. This can also translate across the face to make the eye or cheek twitch. This event was anticipated.
Frequency: 21 affected / 24 at risk

Adverse event: Neck Muscle Twitching
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: TMS stimulation may also cause participant's neck muscles to twitch, similar to having jaw muscles twitch. This event was anticipated.
Frequency: 2 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: TMS stimulation can cause headaches at the site of treatment during or immediately after treatment. These headaches are usually reported as being either tension headaches, or as feeling like a dull ache. Headaches were an anticipated event.
Frequency: 9 affected / 24 at risk

Adverse event: Unsteadiness/Dizziness
Serious: no
Organ System: General disorders
Notes: Some participants experienced a brief degree of unsteadiness or dizziness upon exiting the TMS treatment chair.
Frequency: 3 affected / 24 at risk
Study: NCT03577171

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 13 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 13 at risk

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

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

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 13 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 12 at risk

Adverse event: Electrocardiogram T wave abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 12 at risk
Study: NCT03577275

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 32 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: One subject (female) experienced an SAE of cerebrovascular accident that began \<17 days post the last dose of the study drug (600 mg icosabutate in Dosing Period 4). The Investigator considered the event to be severe and related to the study drug.
Frequency: 1 affected / 32 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 32 at risk
Study: NCT03577730

Adverse event: Pelvic absess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 33 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Ileus requiring re-admittance to hospital
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Nausea with emesis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk
Study: NCT03578276

Adverse event: High intraocular pressure
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 33 at risk

Adverse event: Rebound inflammation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 33 at risk

Adverse event: High intraocular pressure
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Rebound inflammation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 33 at risk

Adverse event: Punctate epithelial erosions
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 33 at risk
Study: NCT03579433

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Notes: Assessed as not related to the ORA With VerifEye
Frequency: 1 affected / 96 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Notes: Assessed as not related to the ORA With VerifEye
Frequency: 1 affected / 96 at risk

Adverse event: Eye laser surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: Assessed as not related to the ORA With VerifEye
Frequency: 2 affected / 96 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Notes: Assessed as not related to the ORA with VerifEye or Barrett Toric Calculator
Frequency: 5 affected / 96 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Assessed as not related to the ORA with VerifEye or Barrett Toric Calculator
Frequency: 7 affected / 96 at risk

Adverse event: Metamorphopsia
Serious: yes
Organ System: Eye disorders
Notes: Assessed as not related to the Barrett Toric Calculator
Frequency: 1 affected / 102 at risk

Adverse event: Intraocular lens implant
Serious: yes
Organ System: Surgical and medical procedures
Notes: Assessed as not related to the Barrett Toric Calculator
Frequency: 1 affected / 102 at risk

Adverse event: Intraocular lens repositioning
Serious: yes
Organ System: Surgical and medical procedures
Notes: Assessed as not related to the Barrett Toric Calculator
Frequency: 1 affected / 102 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Notes: Assessed as not related to the ORA with VerifEye or Barrett Toric Calculator
Frequency: 3 affected / 102 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Assessed as not related to the ORA with VerifEye or Barrett Toric Calculator
Frequency: 4 affected / 102 at risk

Adverse event: Vaginal prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 104 at risk
Study: NCT03579693

Adverse event: Upper respiratory illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Upper respiratory illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk
Study: NCT03579719

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 15 at risk

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

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Medical device site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Catheter site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 15 at risk

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

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

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

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

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

Adverse event: Anal pruritus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

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

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

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 15 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk
Study: NCT03580343

Adverse event: Malignant melanoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: right upper extremity melanoma, with negative sentinel lymph nodes
Frequency: 1 affected / 5 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: squamous cell carcinoma on arm, fast-growing, history of multiple squamous cell carcinomas removed
Frequency: 1 affected / 5 at risk
Study: NCT03581084

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

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk
Study: NCT03581188

Adverse event: Anxiety and confusion arising due to technical difficulties
Serious: no
Organ System: Psychiatric disorders
Notes: One person in the intervention group withdrew due to anxiety and confusion arising due to technical difficulties
Frequency: 1 affected / 49 at risk
Study: NCT03581981

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: patient with history of attempting suicide attempted by pill overdose and contacted others for help. patient was hospitalized and removed from the study and provided care. Outside study providers and review indicated not related to the study.
Frequency: 1 affected / 59 at risk
Study: NCT03582553

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

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

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

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

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

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 9 at risk

Adverse event: Cyst on Foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk