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 @ 10:06 PM
Ignite Modification Date: 2025-12-25 @ 7:43 PM
NCT ID: NCT03238235
Description: Patients who completed the study (12 months of treatment) were asked to return to the center for the Follow-up visit 4 weeks after the last dose of study treatment (4 weeks ±1). However, a patient that was discontinued from the study treatment was asked to return for the early withdrawal visit within 4 weeks of the last dose of study treatment.
Frequency Threshold: 0
Time Frame: Throughout the study, from screening (visits 1 and 2) to EOS/early withdrawal (V11, at week 48 ± 7 days) till follow-up visit (visit 12, at week 52 ± 7 days). This means the AEs were monitored from screening to day 364 ± 7.
Study: NCT03238235
Study Brief: Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo oral suspension (10 mg/mL) twice daily in a fed state placebo: suspension manufactured to mimic givinostat 0 None 0 17 9 17 View
Givinostat Givinostat oral suspension (10 mg/mL) twice daily in a fed state givinostat: suspension of givinostat (10 mg/mL) bid 0 None 0 34 30 34 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Chest injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Face injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Tooth injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood phosphorus increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood sodium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
N-terminal prohormone brain natriuretic peptide increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Muscle hypertrophy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Periarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Hand-arm vibration syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Restrictive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Tooth repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.0 View
Umbilical hernia repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Haematuria SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Hyperpyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View