Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 7:02 PM
Ignite Modification Date: 2025-12-25 @ 4:35 PM
NCT ID: NCT03829657
Description: OL Safety Analysis Set: all enrolled participants who received at least 1 dose of ampreloxetine during the OL period. RW Treatment Safety Analysis Set: all randomized participants who received at least 1 dose of study medication (ampreloxetine or placebo) following randomization. The Safety Analysis Set and FAS were identical for the RW treatment period.
Frequency Threshold: 0
Time Frame: OL Treatment Period: Day 1 to Week 16 (plus a 2 week follow-up period); RW Treatment Period: Week 16 to Week 24 (plus a 2 week follow-up period)
Study: NCT03829657
Study Brief: Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
OL Treatment Period: 0169 Ampreloxetine Rollover Participants who received ampreloxetine in study 0169, received 10 mg oral ampreloxetine QD for up to 16 weeks. 3 None 8 85 48 85 View
OL Treatment Period: De Novo Participants with symptomatic neurogenic orthostatic hypotension (nOH) who met all applicable study inclusion criteria and none of the applicable exclusion criteria, received 10 mg oral ampreloxetine QD for up to 16 weeks. These participants did not roll over from the 0169 study. 0 None 1 32 16 32 View
RW Treatment Period: Placebo Participants who completed the OL treatment period and were randomized to receive oral placebo QD for a further 6 weeks in the RW treatment period. 0 None 2 64 16 64 View
RW Treatment Period: Ampreloxetine Participants who completed the OL treatment period and were randomized to receive 10 mg oral ampreloxetine QD for a further 6 weeks in the RW treatment period. 2 None 4 64 17 64 View
OL Treatment Period: 0169 Placebo Rollover Participants who received the placebo in study 0169, received 10 mg oral ampreloxetine once a day (QD) for up to 16 weeks. 2 None 7 83 41 83 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Bulbar palsy SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Neurological decompensation SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Parkinson's disease SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders 24.1 View
Atrioventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders 24.1 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders 24.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders 24.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Death SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Subcapsular renal haematoma SYSTEMATIC_ASSESSMENT Renal and urinary disorders 24.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Hip arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures 24.1 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 24.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Spinal column injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
On and off phenomenon SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Burning sensation SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Dizziness exertional SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Hypokinesia SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Multiple system atrophy SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Oromandibular dystonia SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Radial nerve palsy SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Restless legs syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Spasmodic dysphonia SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Bruxism SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Hallucination, visual SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Hypomania SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders 24.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Hair growth rate abnormal SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Hand dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Palmar erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 24.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Discomfort SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Colonoscopy SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Glomerular filtration rate abnormal SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Haematocrit decreased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Troponin increased SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 24.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders 24.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders 24.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders 24.1 View
Supine hypertension SYSTEMATIC_ASSESSMENT Vascular disorders 24.1 View
White coat hypertension SYSTEMATIC_ASSESSMENT Vascular disorders 24.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 24.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders 24.1 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders 24.1 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders 24.1 View
Hypermetropia SYSTEMATIC_ASSESSMENT Eye disorders 24.1 View
Open angle glaucoma SYSTEMATIC_ASSESSMENT Eye disorders 24.1 View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders 24.1 View
Calculus urinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders 24.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders 24.1 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders 24.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders 24.1 View
Urinary hesitation SYSTEMATIC_ASSESSMENT Renal and urinary disorders 24.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders 24.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Atrioventricular block first degree SYSTEMATIC_ASSESSMENT Cardiac disorders 24.1 View
Bundle branch block left SYSTEMATIC_ASSESSMENT Cardiac disorders 24.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders 24.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 24.1 View
Allergy to vaccine SYSTEMATIC_ASSESSMENT Immune system disorders 24.1 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders 24.1 View
Gynaecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 24.1 View
Priapism SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 24.1 View
Cholecystitis chronic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 24.1 View
Haemangioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 24.1 View
Device occlusion SYSTEMATIC_ASSESSMENT Product Issues 24.1 View
Walking disability SYSTEMATIC_ASSESSMENT Social circumstances 24.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 24.1 View
Migraine with aura SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Parkinson's disease SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders 24.1 View
Back injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Post procedural discomfort SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Soft tissue injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 24.1 View
Large intestine polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 24.1 View
Mobility decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 24.1 View
Diastolic hypertension SYSTEMATIC_ASSESSMENT Vascular disorders 24.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 24.1 View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders 24.1 View
Anaemia vitamin B12 deficiency SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 24.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders 24.1 View
Cystoscopy SYSTEMATIC_ASSESSMENT Investigations 24.1 View
Endometrial hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 24.1 View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 24.1 View
Uterine enlargement SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 24.1 View
Bulbar palsy SYSTEMATIC_ASSESSMENT Nervous system disorders 24.1 View