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 @ 2:22 AM
Ignite Modification Date: 2025-12-26 @ 12:54 AM
NCT ID: NCT02507934
Description: An Adverse Event (AE) was defined as any untoward medical occurence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Frequency Threshold: 0
Time Frame: The specific period of time over which adverse events data were collected was from day 1 to day 21±1
Study: NCT02507934
Study Brief: Tolerability, Safety and Efficacy of Lubricin Versus Sodium Hyaluronate Eye Drops in Patients With Moderate 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
Lubricin 150 μg/ml (SAF) Lubricin 150 μg/ml eye drops solution Both test and comparator were instilled b.i.d. (two times a day), one drop into each eye, from day 1 to day 7±1 and, then, from 2 to 6 times a day as needed (i.e. prn), one drop into each eye, from day 7±1 to day 14±1. After the end of the treatment period, all the subjects used Vismed® 0.18% b.i.d. every 8±1 h, one drop into each eye, from day 14±1 to day 21±1. Before the start of the treatment (from day -6/-4 to day -1), the subjects were allowed to use only Nebul®, NaCl 0.9% ocular solution q.i.d. every 4±1 h, one drop into each eye. Lubricin: Lubricin 150 µg/ml eye drops 0 None 0 20 2 20 View
Sodium Hyaluronate 0.18% (SAF) Vismed®, 0.18% sodium hyaluronate eye drops Both test and comparator were instilled b.i.d. (two times a day), one drop into each eye, from day 1 to day 7±1 and, then, from 2 to 6 times a day as needed (i.e. prn), one drop into each eye, from day 7±1 to day 14±1. After the end of the treatment period, all the subjects used Vismed® 0.18% b.i.d. every 8±1 h, one drop into each eye, from day 14±1 to day 21±1. Before the start of the treatment (from day -6/-4 to day -1), the subjects were allowed to use only Nebul®, NaCl 0.9% ocular solution q.i.d. every 4±1 h, one drop into each eye. Sodium Hyaluronate: Sodium hyaluronate 0.18% eye drops 0 None 0 20 1 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.1) View