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 @ 11:45 PM
Ignite Modification Date: 2025-12-25 @ 9:38 PM
NCT ID: NCT02216851
Description: Each subject was questioned about AEs at each clinical visit starting at the treatment visit, Visit 2. The question asked was "Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during each examination, observations by the study personnel, reactions recorded in the subject diary that were ongoing on Day 14 or spontaneous reports from the subjects during the study.
Frequency Threshold: 0
Time Frame: During study participation, up to 12 months.
Study: NCT02216851
Study Brief: Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Restylane Perlane Single injection of Restylane Perlane in nasal dorsum and/or nasal root Restylane Perlane: Intradermal injection 0 None 4 98 0 98 View
No-treatment Control No-treatment control group do not receive any treatment during the main study period 0 None 1 33 0 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fallopian tube obstruction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
mixed hemorrhoids SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Solid pseudopapillary tumor of the pancreas SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
peritoneal adhesions SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):