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 @ 5:30 PM
Ignite Modification Date: 2025-12-25 @ 3:04 PM
NCT ID: NCT02863068
Description: None
Frequency Threshold: 0
Time Frame: Up to 10 weeks
Study: NCT02863068
Study Brief: Topical Sodium Nitrite in Sickle Cell Disease and Leg Ulcers
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 Participants will receive placebo and standard of care Placebo: Participants will have Placebo applied to total ulcerated area. If a participant has more than one ulcer, all of them will be treated with placebo in this intervention. 0 None 4 10 9 10 View
Topical Sodium Nitrite Participants will receive 2% topical sodium nitrite cream and standard of care Topical Sodium Nitrite: Participants will have 0.1 cm of 2% sodium nitrite cream applied per 1 cm\^2 of the total ulcerated area. Areas will be rounded to the nearest 1 cm\^2. If a participant has more than one ulcer, all of them will be treated with either "study cream" in this intervention. 0 None 3 8 4 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vaso-occlusive Crisis NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Ulcer Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Acute Myeloid Leukemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vaso-occlusive Crisis NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Chest Wall Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Ulcer Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Abnormal Blood Smear NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Critical Low Lab Value NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Body Ache NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View