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 @ 12:49 PM
Ignite Modification Date: 2025-12-25 @ 12:15 PM
NCT ID: NCT01514461
Description: Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Frequency Threshold: 5
Time Frame: None
Study: NCT01514461
Study Brief: A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome
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 In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary. None None 6 15 15 15 View
LCQ908 40 mg In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary. None None 3 14 14 14 View
LCQ908 20 mg In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet will be followed and recorded in patient diary. None None 6 15 15 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CARDIAC ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
GASTROINTESTINAL DISORDER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
PANCREATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
PANCREATITIS ACUTE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
HYPERTRANSAMINASAEMIA SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
INCISIONAL HERNIA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
HEPATIC ENZYME INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
MALIGNANT PALATE NEOPLASM SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
CEREBRAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
FEMORAL ARTERY OCCLUSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
CARDIAC ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
CARDIAC FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
PALPITATIONS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
SUPRAVENTRICULAR EXTRASYSTOLES SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
DEAFNESS SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
BLEPHARITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
CONJUNCTIVAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
ABDOMINAL DISCOMFORT SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL DISTENSION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
BARRETT'S OESOPHAGUS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CHANGE OF BOWEL HABIT SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DEFAECATION URGENCY SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DENTAL CARIES SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DIVERTICULUM SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
FREQUENT BOWEL MOVEMENTS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
HYPERCHLORHYDRIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
INGUINAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
PANCREATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
RECTAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
TOOTHACHE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
CYST SYSTEMATIC_ASSESSMENT General disorders MedDRA View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
MALAISE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
ALLERGY TO ARTHROPOD STING SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
ALLERGY TO PLANTS SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
FOOD ALLERGY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CYSTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
EAR INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
ERYSIPELAS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
HAND-FOOT-AND-MOUTH DISEASE SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
HORDEOLUM SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
JOINT ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
LARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
LOCALISED INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
PHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
TINEA INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
TOOTH ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
TOOTH INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CHEST INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
LIGAMENT SPRAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
MUSCLE RUPTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
POST PROCEDURAL COMPLICATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
RIB FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
SCAR SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
SPORTS INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
TOOTH FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
BLOOD GLUCOSE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
CAROTID BRUIT SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HAEMOGLOBIN DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HEPATIC ENZYME INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
WEIGHT INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPOCALCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPOGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
VITAMIN D DEFICIENCY SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
BURSITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
INTERVERTEBRAL DISC PROTRUSION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCLE FATIGUE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULOSKELETAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
NECK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
SJOGREN'S SYNDROME SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
TENDONITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
LIPOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
NEOPLASM SKIN SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
PAPILLOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
DYSGEUSIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
LETHARGY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
SCIATICA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
STRESS SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
DYSURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
DYSPNOEA EXERTIONAL SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
SINUS CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
ACNE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
ROSACEA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
SKIN LESION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
XANTHOMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
HOT FLUSH SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
CORONARY ARTERY STENOSIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
ABDOMINAL RIGIDITY SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ENTERITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
FAECES DISCOLOURED SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
FAECES SOFT SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
FLATULENCE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
SUBCUTANEOUS ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
LIMB INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
IRON DEFICIENCY SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MYOPATHY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
RENAL FAILURE ACUTE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View