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 @ 2:45 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT02647359
Description: The safety population included all randomized participants who received at least 1 dose of study drug. AEs were summarized separately for Stage 1 and for the overall ataluren experience, which included all participants who received ataluren throughput the study (Stage 1, open-label extension period \[Stage 2\], and sub-study).
Frequency Threshold: 0
Time Frame: Baseline up to Week 244
Study: NCT02647359
Study Brief: Study of Ataluren in Participants With Nonsense Mutation Aniridia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stage 1: Ataluren Participants received ataluren orally TID at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 48 weeks in Stage 1 (double-masked period). 0 None 1 26 22 26 View
Stage 1: Placebo Participants received placebo matched to ataluren TID orally in the morning, at midday, and in the evening for 48 weeks in Stage 1 (double-masked period). 0 None 0 13 10 13 View
Overall Ataluren Exposure Participants received ataluren orally TID at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 48 weeks in Stage 1 (double-masked period) and for additional 96 weeks in Stage 2 (open-label extension period). Participants, who completed Stage 2 and agreed to continue in open-label sub-study, continued to receive ataluren treatment at same dose as mentioned above, for 96 weeks. 0 None 1 37 35 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Mental disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Frequent bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Faeces soft SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Tooth impacted SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Local swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Medical device site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Sensation of pressure SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Corneal opacity SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eyelid ptosis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lenticular opacities SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Keratopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lens discolouration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Blepharospasm SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye inflammation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Photokeratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Punctate keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Roseola SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Atypical Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis of male external genital organ SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lyme disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urine leukocyte esterase positive SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Nitrite urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Urine ketone body present SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Urine Leukocyte esterase positive SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Bacterial test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mood altered SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Attention deficit/Hyperactivity disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Obsessive-compulsive disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Corneal Abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Sunburn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Epiphysiolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Balanoposthitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Phimosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Motion sickness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View