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 @ 3:59 PM
Ignite Modification Date: 2025-12-25 @ 2:02 PM
NCT ID: NCT02056392
Description: Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).
Frequency Threshold: 0
Time Frame: AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit.
Study: NCT02056392
Study Brief: To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Selumetinib Selumetinib 75mg bs (3x25mg capsules) None None 0 51 5 51 View
Moxifloxacin Moxiflxacin 400 mg (open label) None None 0 51 5 51 View
Placebo Selumetinib placebo (3 capsules) None None 1 50 4 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View