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 @ 7:31 PM
Ignite Modification Date: 2025-12-25 @ 5:13 PM
NCT ID: NCT04488003
Description: If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Frequency Threshold: 5
Time Frame: All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment.
Study: NCT04488003
Study Brief: Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part A: Ulixertinib Oral, 600 mg, twice daily, for 28-days in each treatment cycle Ulixertinib: Oral, 600 mg, twice daily, for 28-days in each treatment cycle 52 None 41 77 76 77 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MEDDRA v.25.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MEDDRA v.25.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MEDDRA v.25.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v.25.1 View
Anorectal infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v.25.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v.25.1 View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v.25.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v.25.1 View
Rectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v.25.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v.25.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v.25.1 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v.25.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA v.25.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA v.25.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA v.25.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA v.25.1 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA v.25.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA v.25.1 View
Malignant gastrointestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v.25.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v.25.1 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v.25.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v.25.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA v.25.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA v.25.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA v.25.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA v.25.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA v.25.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA v.25.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA v.25.1 View
Cauda equina syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA v.25.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA v.25.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA v.25.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA v.25.1 View
Postrenal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA v.25.1 View
Gallbladder rupture SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MEDDRA v.25.1 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MEDDRA v.25.1 View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MEDDRA v.25.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v.25.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v.25.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v.25.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v.25.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA v.25.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA v.25.1 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA v.25.1 View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA v.25.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDDRA v.25.1 View
Drug reaction with eosinophilia and systemic symptoms SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA v.25.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA v.25.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MEDDRA v.25.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MEDDRA v.25.1 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA v.25.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA v.25.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v.25.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v.25.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v.25.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v.25.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v.25.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v.25.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v.25.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA v.25.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA v.25.1 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA v.25.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA v.25.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA v.25.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA v.25.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MEDDRA v.25.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MEDDRA v.25.1 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MEDDRA v.25.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MEDDRA v.25.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA v.25.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA v.25.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA v.25.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA v.25.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA v.25.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA v.25.1 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA v.25.1 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA v.25.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA v.25.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v.25.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v.25.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v.25.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v.25.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v.25.1 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v.25.1 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v.25.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v.25.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MEDDRA v.25.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MEDDRA v.25.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MEDDRA v.25.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA v.25.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA v.25.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v.25.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v.25.1 View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA v.25.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA v.25.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA v.25.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA v.25.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA v.25.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA v.25.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA v.25.1 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA v.25.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA v.25.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA v.25.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MEDDRA v.25.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDDRA v.25.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA v.25.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA v.25.1 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDDRA v.25.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA v.25.1 View