TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01657253

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: During the study 5 patients reported conjunctivitis:

2 patients with allergic conjunctivitis

1. patient with bacterium conjunctivitis
2. patients with acute nonspecific conjunctivitis
Frequency: 5 affected / 93 at risk

Adverse event: ocular burning sensation
Serious: no
Organ System: Eye disorders
Notes: During the study, 3 patients reported ocular burning sensation
Frequency: 3 affected / 93 at risk

Adverse event: Pruritus
Serious: no
Organ System: Eye disorders
Notes: In the systematic evaluation, 2 patients reported pruritus
Frequency: 2 affected / 93 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Notes: In the systematic evaluation, 1 patient presented red eye
Frequency: 1 affected / 93 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the evaluation, 4 patients had rhinitis.
Frequency: 1 affected / 93 at risk

Adverse event: Dental extraction
Serious: no
Organ System: Surgical and medical procedures
Notes: 1 patient had infection in one piece dental during his participation in this study
Frequency: 1 affected / 93 at risk

Adverse event: Lower back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 patient had lower back pain during its participation in the present study
Frequency: 1 affected / 93 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the evaluation, 4 patients had rhinitis.
Frequency: 3 affected / 90 at risk

Adverse event: Back spasm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 patient refered back spasm during his participation in the present study
Frequency: 1 affected / 90 at risk

Adverse event: Change in the visual acuity
Serious: no
Organ System: Eye disorders
Notes: 1 patient in the PRO-148 group reported change in the visual acuity. When the clinical ophthalmologist reviewed to the patient, the visual acuity was good.
Frequency: 1 affected / 90 at risk
Study: NCT01657266

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Notes: This moderate adverse event does not relationship with the study drug. The clinically significant cystoid macular edema occurs after cataract surgery.
Frequency: 1 affected / 73 at risk

Adverse event: Traumatic corneal desepithelization
Serious: no
Organ System: Eye disorders
Notes: This moderate event does not have relationship with the study drug. The patient presented an accidental ocular injure.
Frequency: 1 affected / 73 at risk

Adverse event: Posterior Capsular Rupture
Serious: no
Organ System: Eye disorders
Notes: This mild adverse event does not relationship with the study drug. The posterior capsular rupture occurs after cataract surgery.
Frequency: 1 affected / 73 at risk

Adverse event: Conjunctivitis viral
Serious: no
Organ System: Eye disorders
Notes: This severe adverse event does not have relationship with the study drug. This patient had hypothyroidism like concomitant disease, this clinical condition would be able to increase the risk to have an infectious disease.
Frequency: 1 affected / 73 at risk

Adverse event: Inflammatory cells in the corneal endothelium
Serious: no
Organ System: Eye disorders
Notes: This moderate adverse event does not have relationship with the study drug. The presence of inflammatory cells in the corneal endothelium is related to cataract surgery procedure.
Frequency: 1 affected / 73 at risk

Adverse event: Rhegmatogenous retinal detachment
Serious: yes
Organ System: Eye disorders
Notes: This serious adverse event occurred during the systematic assessment. The event was not related with the pharmacological intervention.
Frequency: 1 affected / 75 at risk

Adverse event: Retinal artery occlusion
Serious: yes
Organ System: Eye disorders
Notes: This serious adverse event occurred during systematic assessment. The adverse event was not related with the pharmacological intervention.
Frequency: 1 affected / 75 at risk

Adverse event: fall from their own height
Serious: no
Organ System: Vascular disorders
Notes: The mild adverse event does not have relationship with the study drug.
Frequency: 1 affected / 75 at risk

Adverse event: intraocular lens exchange
Serious: no
Organ System: Eye disorders
Notes: This adverse event does not have relationship with the study drug. The reason of intraocular lens exchange was: error in the intraocular lens power calculation.
Frequency: 1 affected / 75 at risk
Study: NCT01657292

Adverse event: Tonsil cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 61 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Wound necrosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Condition aggravated
Serious: yes
Organ System: General disorders
Notes: Further deepening of burn wound
Frequency: 2 affected / 61 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk
Study: NCT01657305

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk
Study: NCT01657370

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 28 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk
Study: NCT01657617

Adverse event: Fatal hemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk
Study: NCT01657760

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: subjective experience of nausea
Frequency: 1 affected / 20 at risk

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

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

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: stomach upset
Frequency: 1 affected / 20 at risk

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

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: subjective experience of nausea
Frequency: 8 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: temporary dizziness
Frequency: 5 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 20 at risk

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

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: occurring after study medication given
Frequency: 1 affected / 20 at risk
Study: NCT01657903

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 56 at risk
Study: NCT01657942

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 24 affected / 101 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 19 affected / 101 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 19 affected / 101 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 101 at risk

Adverse event: Penile / Testicular Pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 14 affected / 101 at risk

Adverse event: Haematospermia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 13 affected / 101 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 101 at risk

Adverse event: Ejaculation disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 101 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 101 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 101 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 101 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 101 at risk
Study: NCT01658150

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

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Poor coordination
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 11 at risk

Adverse event: Frequent urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 11 at risk

Adverse event: Menstrual irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 11 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 11 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Decreased energy
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk
Study: NCT01658657

Adverse event: Electrolyte imbalance
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 7 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Electrolyte imbalance
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk
Study: NCT01658735

Adverse event: Increase in Lower Extremity Tingling/Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Exacerbation of Irritable bowel syndrome
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Abdominal pain/Flank pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Increase in Lower Extremity Tingling/Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk
Study: NCT01658813

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 12 affected / 18 at risk

Adverse event: Nausea/emesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 18 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 18 at risk

Adverse event: arthralgia/myalgia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Catarrhal symptoms
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Aspartate aminotransferase elevation
Serious: no
Organ System: Investigations
Frequency: 3 affected / 18 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 18 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 18 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 18 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

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

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

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Alanine aminotransferase elevation
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Alkaline phosphatase elevation
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue 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: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk
Study: NCT01658839

Adverse event: Trabeculectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 25 at risk
Study: NCT01658904

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk
Study: NCT01658930

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 344 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 344 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 28 affected / 344 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 344 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 344 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 38 affected / 344 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 34 affected / 344 at risk

Adverse event: Dyspareunia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 19 affected / 344 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 17 affected / 344 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 36 affected / 344 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 20 affected / 344 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 338 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 338 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 19 affected / 338 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 338 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 338 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 338 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 338 at risk

Adverse event: Dyspareunia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 21 affected / 338 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 23 affected / 338 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 35 affected / 338 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 338 at risk
Study: NCT01659125

Adverse event: Increased Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: There was one serious adverse event with a patient hospitalized for increased depression and suicidal ideation following onset of an acute psychosocial stressor which was unrelated to OCD symptoms
Frequency: 1 affected / 24 at risk
Study: NCT01659320

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk
Study: NCT01659541

Adverse event: Hemodynamic effect - Initial increases in blood pressure and decreases in heart rate
Serious: no
Organ System: Nervous system disorders
Notes: Use of the Cough System was associated with some side effects (n=6), most notably increases in blood pressure, consistent with AD. Over a period of several weeks of daily SCS however, those responses were eventually resolved in each subject.
Frequency: 6 affected / 12 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Nervous system disorders
Notes: The Cough System have had to be explanted in one participant due an increase in frequency and severity of muscle spasm.
Frequency: 1 affected / 12 at risk