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: 2025-12-25 @ 2:07 AM
Ignite Modification Date: 2025-12-26 @ 12:33 AM
NCT ID: NCT01842360
Description: None
Frequency Threshold: 5
Time Frame: from enrollment until end of follow-up, 18 months
Study: NCT01842360
Study Brief: Evaluation of the Efficacy and Safety of MV130 in Chronic Obstructive Pulmonary Disease (COPD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MV130 The participants will receive daily dose of MV130 during 12 months MV130: The participants will receive daily dose of MV130 during 12 months 1 None 9 97 26 97 View
Placebo The participants will receive daily dose of placebo during 12 months Placebo: The participants will receive daily dose of placebo during 12 months 2 None 12 101 13 101 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
metastases to central nervous system NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Brain neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Adenocarcinoma of colon NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Aenocarcinoma pancreas NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Unstable angina NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 25.0 View
Petit mal epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Haemorrhage intracranial NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Apendicitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pulmonary aspergillosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Mycobacterium avium complex infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Cytomegalovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View