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 @ 6:42 PM
Ignite Modification Date: 2025-12-25 @ 4:13 PM
NCT ID: NCT00918957
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00918957
Study Brief: A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TIP (Tobramycin Inhalation Powder) Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment. None None 0 30 4 30 View
Placebo Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). None None 2 32 6 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.X View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10.X View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View