TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01548768

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant was admitted during overseas travel to hospital in Ecuador for an episode of acute dyspnea - she spent one night in a hospital in Panama before returning to the US.
Frequency: 1 affected / 8 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject reported new pruritic skin rash (c/w eczema on exam) on start of study medication. Study medication d/c'ed 1mnth later and initiated medrol w/ good response. Later followed up with dermatology who confirmed eczema.
Frequency: 1 affected / 8 at risk

Adverse event: Worsening Migraine
Serious: no
Organ System: General disorders
Notes: Subject w/ h/o migraine; during study visit, mild migraine in morning worsened (BP 140/69, HR 100) - given acetaminophen 500mg x2 - decision made to admit to ED for observation. Same-day discharge from ED.
Frequency: 1 affected / 121 at risk

Adverse event: Mobitz II Heart Block
Serious: no
Organ System: Cardiac disorders
Notes: Could not tolerate adenosine - subject went into heart block (otherwise asymptomatic); IRB gave approval for regadenoson on re-try later.
Frequency: 1 affected / 121 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: General disorders
Notes: Angina during adenosine stress test w/ ischemic ECG changes during test. Resolved on completion of test.
Frequency: 1 affected / 121 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Short run of atrial tachycardia which self-reverted to normal sinus rhythm after 100mg aminophyllin. No re-occurance.
Frequency: 1 affected / 121 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Notes: Subject had panic attack during stress scan - test was aborted and not retried.
Frequency: 1 affected / 121 at risk

Adverse event: Thrombophlebitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject had swelling from IV site; prescribed Keflex for 10 days, which resolved.
Frequency: 1 affected / 121 at risk
Study: NCT01548885

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Mild, Not device related
Frequency: 4 affected / 146 at risk
Study: NCT01549002

Adverse event: Oxygen desaturation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT01549041

Adverse event: daytime drowsiness
Serious: no
Organ System: Nervous system disorders
Notes: excessive sedation during the day
Frequency: 4 affected / 18 at risk
Study: NCT01549314

Adverse event: Minor
Serious: no
Organ System: Investigations
Notes: Lightheaded
Frequency: 1 affected / 26 at risk
Study: NCT01549613

Adverse event: hospital readmission
Serious: no
Organ System: Investigations
Notes: returned to hospital within 30 days
Frequency: 1 affected / 50 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: developed hives during course of treatment
Frequency: 1 affected / 50 at risk

Adverse event: scheduled surgery for ovarian cyst
Serious: no
Organ System: General disorders
Notes: The surgery date was moved a week later after completing antibiotic
Frequency: 1 affected / 50 at risk

Adverse event: Returned to pmc for HPT and Diabetes
Serious: no
Organ System: General disorders
Notes: Patient admitted to medical service for hyperkalemia
Frequency: 1 affected / 50 at risk

Adverse event: hospital readmission
Serious: no
Organ System: Investigations
Notes: returned to hospital within 30 days
Frequency: 2 affected / 50 at risk

Adverse event: redman syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Developed reaction to antibiotic
Frequency: 1 affected / 50 at risk

Adverse event: Sought treatment of town
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Patient reported that they went to doctor in home town for further treatment
Frequency: 1 affected / 50 at risk

Adverse event: Iv infiltrated
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: IV infiltrated while antibiotic infusing.
Frequency: 1 affected / 50 at risk

Adverse event: Animal bite
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: patient obtain dog bite after enrollment and returned to ED for treatment
Frequency: 1 affected / 50 at risk

Adverse event: Red streak
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: a red streak from cellulitis to arm
Frequency: 1 affected / 50 at risk
Study: NCT01549886

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2 at risk

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

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Neutrophils count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk
Study: NCT01549977

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

Adverse event: Urinary sediment present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk
Study: NCT01550289

Adverse event: Anaemia megaloblastic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 127 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 126 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 126 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 11 affected / 126 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 126 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 126 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 61 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 61 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 3 affected / 61 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 61 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 61 at risk
Study: NCT01550471

Adverse event: Headaches/migraine
Serious: no
Organ System: General disorders
Frequency: 5 affected / 21 at risk

Adverse event: Respiratory infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Swollen eyelid and adenopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 21 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 21 at risk

Adverse event: Headaches/migraine
Serious: no
Organ System: General disorders
Frequency: 4 affected / 22 at risk

Adverse event: Respiratory infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 22 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Foot pain during sports
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Impetigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Headaches/migraine
Serious: no
Organ System: General disorders
Frequency: 5 affected / 22 at risk

Adverse event: Respiratory infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 22 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Foot pain during sports
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Oral pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk
Study: NCT01550510

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

Adverse event: Low Hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk
Study: NCT01550705

Adverse event: Influenza like illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk
Study: NCT01551056

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 46 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk
Study: NCT01551095

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk
Study: NCT01551303

Adverse event: irritation of nasal passages, temporary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk
Study: NCT01551420

Adverse event: Unrelated adverse event
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject hospitalized due to an unrelated cellulitis flare-up in his lower limb
Frequency: 1 affected / 39 at risk

Adverse event: Unrelated adverse event
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Subject was in a car accident in a rental car on his way to the airport after the study had ended
Frequency: 1 affected / 39 at risk

Adverse event: Adverse event
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal pain related to wearing or using the device: including back or ankle pain
Frequency: 2 affected / 39 at risk

Adverse event: Adverse event
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Subject was using the prosthesis to eat with a fork and sustained a minor cut to his lip.
Frequency: 1 affected / 39 at risk

Adverse event: Adverse event
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject had a skin irritation, possibly due to socket wear
Frequency: 1 affected / 13 at risk
Study: NCT01551550

Adverse event: Corneal oedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 41 at risk

Adverse event: Corneal oedema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 41 at risk
Study: NCT01551693

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT01551745

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk
Study: NCT01551888

Adverse event: Aortic valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 24 at risk
Study: NCT01551979

Adverse event: Acute exacerbation of psychosis
Serious: yes
Organ System: Psychiatric disorders
Notes: Acute exacerbation of psychosis was assessed to be possibly related to participation in the study, but likely not related to the TMS. Subject was hospitalized.
Frequency: 1 affected / 10 at risk

Adverse event: Discomfort with TMS
Serious: no
Organ System: Nervous system disorders
Notes: Discomfort with the TMS-EEG measures being done at baseline in the frontal lobe area. Discomfort was assessed to be related to the study.
Frequency: 1 affected / 10 at risk

Adverse event: Blood pressure increase
Serious: no
Organ System: Cardiac disorders
Notes: Blood pressure elevation was assessed to be possibly related to the study.
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headaches were reported during EEG measures during baseline assessment, pre-TMS, and post-TMS. Headaches were assessed as possibly or probably related to the study.
Frequency: 2 affected / 10 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Neck pain reported due to dystonia or heaviness of the coil. Neck pain due to dystonia was assessed as not related to study participation. Neck pain due to the coil was assessed as probably related to the study.
Frequency: 3 affected / 10 at risk

Adverse event: Head heaviness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Heaviness was reported on right side of head during and after TMS. Headache was assessed to be possibly related to the study.
Frequency: 1 affected / 10 at risk

Adverse event: Change in energy level
Serious: no
Organ System: Nervous system disorders
Notes: Subject reported being mildly or moderately tired post-TMS.
Frequency: 1 affected / 10 at risk

Adverse event: Change in mood
Serious: no
Organ System: Psychiatric disorders
Notes: Subject reported feeling depressed. Change in mood assessed to be possibly related to the study.
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headaches were reported during EEG measures during baseline assessment, pre-TMS, and post-TMS. Headaches were assessed as possibly or probably related to the study.
Frequency: 1 affected / 7 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Scalp pain reported as pressure on scalp over the ears and top of head. Scalp pain was assessed as possibly related to the study.
Frequency: 1 affected / 7 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Neck pain reported due to dystonia or heaviness of the coil. Neck pain due to dystonia was assessed as not related to study participation. Neck pain due to the coil was assessed as probably related to the study.
Frequency: 1 affected / 7 at risk
Study: NCT01552213

Adverse event: Intrauterine Fetal Demise
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 45 at risk
Study: NCT01552369

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 100 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk
Study: NCT01552603

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk
Study: NCT01552928

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 59 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 59 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 59 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 60 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 60 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 60 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 60 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk
Study: NCT01552954

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 1 affected / 131 at risk

Adverse event: Elevated serum creatinine
Serious: no
Organ System: Renal and urinary disorders
Notes: Elevation of serum creatinine level : Physician assessed ARB could not be continued
Frequency: 2 affected / 125 at risk
Study: NCT01553058

Adverse event: vasovagal syncope
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 33 at risk

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

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: joint range of motion decrease
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 31 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

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

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 33 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 33 at risk

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 33 at risk