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 @ 10:15 PM
Ignite Modification Date: 2025-12-25 @ 7:49 PM
NCT ID: NCT04517435
Description: None
Frequency Threshold: 0
Time Frame: 24 months (2 years)
Study: NCT04517435
Study Brief: ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase I: ME-401 + R-CHOP Dose Level 1 Participants will receive ME-401 dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose R-CHOP. ME-401 (60 mg) will be given on days 1-4 (dose level 1) of a 21 day cycle with standard dose R-CHOP x 6 cycles. 0 None 1 3 3 3 View
Phase I: ME-401 + R-CHOP Dose Level 2 Participants will receive ME-401 dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose R-CHOP. ME-401 (60 mg) will be given on days 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles. 0 None 6 6 6 6 View
Phase II: ME-401 + R-CHOP Participants will receive ME-401 dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose R-CHOP. ME-401 (60 mg) will be given on days 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles. 0 None 2 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Jejunal Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Laryngeal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View