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 @ 4:21 PM
Ignite Modification Date: 2025-12-25 @ 2:17 PM
NCT ID: NCT01537666
Description: AEs were grouped by system organ class and summarized by dose level at the time of onset of the AE. All AE summaries are restricted to TEAEs, defined as AEs that began on or after the start of study drug. AEs without an onset date or time were excluded from the summary tables as it was not possible to allocate to a particular treatment.
Frequency Threshold: 0
Time Frame: All 25 subjects enrolled received at least part of their allocated study treatments and are included in the safety population. All subjects received their allocated dose, and in Part 2 of the study, 5 subjects received both the 32 mg and 80 mg doses.
Study: NCT01537666
Study Brief: Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AeroVanc 16 mg in Healthy Volunteers Single inhaled dose of 16 mg AeroVanc in health volunteers. None None 0 6 2 6 View
AeroVanc 32 mg in Healthy Volunteers Single inhaled dose of 32 mg AeroVanc in health volunteers. None None 0 6 5 6 View
AeroVanc 80 mg in Healthy Volunteers Single inhaled dose of 80 mg AeroVanc in health volunteers. None None 0 6 2 6 View
AeroVanc 32 mg in Cystic Fibrosis Patients Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose. None None 1 6 6 6 View
AeroVanc 80 mg in Cystic Fibrosis Patients Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose. None None 0 6 5 6 View
IV Vancomycin 250 mg in Healthy Volunteers Comprised of 2 patients from each of the AeroVanc in Healthy Volunteer groups. None None 0 6 2 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
AGGRAVATED RENAL COLIC None Renal and urinary disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea None Gastrointestinal disorders MedDRA View
Nausea None Gastrointestinal disorders MedDRA View
Chest discomfort None General disorders MedDRA View
Feeling hot None General disorders MedDRA View
Upper respiratory tract infection None Infections and infestations MedDRA View
Excoriation None Injury, poisoning and procedural complications MedDRA View
Oral discomfort None Gastrointestinal disorders MedDRA View
Forced expiratory volume decreased None Investigations MedDRA View
Liver function test abnormal None Investigations MedDRA View
Dizziness None Nervous system disorders MedDRA View
Headache None Nervous system disorders MedDRA View
Cough None Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea None Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory disorder None Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory tract congestion None Respiratory, thoracic and mediastinal disorders MedDRA View
Drug eruption None Skin and subcutaneous tissue disorders MedDRA View