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 @ 6:37 PM
Ignite Modification Date: 2025-12-25 @ 4:07 PM
NCT ID: NCT02831257
Description: None
Frequency Threshold: 0
Time Frame: 24 months
Study: NCT02831257
Study Brief: AZD2014 In NF2 Patients With Progressive or Symptomatic Meningiomas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AZD2014 18 patients will be enrolled in this study in a single stage. * AZD2014 orally, 2 times a day on 2 consecutive day out of every 7 days. * One cycle will consist of 28 days (1 cycle = 28 days). 0 None 7 18 18 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Heat stroke NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT Investigations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Psychosis NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypertriglyceridemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Jaw weakness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspareunia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
High cholesterol NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperuricemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyphophosphatemia NON_SYSTEMATIC_ASSESSMENT Investigations None View
infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
malaise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Difficulty chewing NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pruritis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash, acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
amenorrhea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
vaginal pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT Investigations None View
white blood cells decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View