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 @ 10:13 PM
Ignite Modification Date: 2025-12-25 @ 7:48 PM
NCT ID: NCT02510235
Description: An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product. The adverse Events were reported at the patient level at both eyes.
Frequency Threshold: 0
Time Frame: AEs were assessed throughout the clinical investigation (V1 at Day -14 - -8; V2 at Day 1; V3 at Day 14 ± 2; V4 at Day 28 ± 4) up to final visit, at day 31- 41 (V5).
Study: NCT02510235
Study Brief: Tolerability, Safety and Efficacy of Lubricin vs Sodium Hyaluronate Eye Drops in Subjects 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 SAF Lubricin 150 µg/ml eye drops. The test investigational device as well as the comparator, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13% Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Lubricin: Lubricin 150 µg/ml eye drops 0 None 0 27 1 27 View
Sodium Hyaluronate SAF Sodium hyaluronate 0.13% eye drops. The comparator, as well as the test investigational device, was instilled i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days. Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d. Sodium Hyaluronate: Sodium hyaluronate 0.13% eye drops 0 None 0 29 2 29 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Eye oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Foreign body sensation in eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View