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 @ 4:02 AM
Ignite Modification Date: 2025-12-26 @ 2:55 AM
NCT ID: NCT03569202
Description: ADE (adverse device effect); AE (adverse event); SADE (serious adverse device effect); SAE (serious adverse event); USADE (unanticipated serious adverse device effect) Total Number of Participants at Risk (safety population); Emulsion Eye Drops: 3 + 9 + 26 = 38 participants; Control Eye Drops: 0 + 9 + 26 = 35 participants. Adverse events were collected throughout the study during visits to study site, in study diaries, and from direct contacts to study personnel between visits.
Frequency Threshold: 0
Time Frame: Part 1: 1 day; Part 2: 10 days; Part 3: 30 days
Study: NCT03569202
Study Brief: Piiloset Trehalose Emulsion Eye Drop Study in Moderate or Severe Dry Eye
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Emulsion Eye Drops Daily treatment with Piiloset Trehalose Emulsion Eye Drops Adverse events are reported for the safety population in all parts of the study, including all randomized subjects who received Piiloset Trehalose Emulsion Eye Drops at least once and from whom at least one safety measurement was obtained after randomization. 0 None 0 38 1 38 View
Control Eye Drops Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device) Adverse events are reported for the safety population in all parts of the study, including all randomized subjects who received Hyaluronic Acid Eye Drops at least once and from whom at least one safety measurement was obtained after randomization. 0 None 0 35 0 35 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
AE (adverse event) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders EN ISO 14155:2011 View