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 @ 11:53 AM
Ignite Modification Date: 2025-12-25 @ 11:54 AM
NCT ID: NCT02840461
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT02840461
Study Brief: Clinical Endpoint Study of Ivermectin 1% Cream
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SoolantraTM (Ivermectin) Cream, 1% Reference product, manufactured by Galderma Laboratories, L.P. Ivermectin Cream, 1% 0 None 0 257 24 257 View
Ivermectin Cream, 1% Test product, manufactured by Actavis Laboratories UT, Inc. Ivermectin Cream, 1% 0 None 0 259 18 259 View
Placebo/Vehicle Cream Placebo, manufactured by Actavis Laboratories UT, Inc. Placebo/Vehicle cream 0 None 0 114 14 114 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.1) View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.1) View
Rosacea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.1) View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.1) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.1) View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.1) View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.1) View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.1) View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.1) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.1) View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.1) View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.1) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.1) View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.1) View
Application site eczema SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.1) View
Application site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.1) View
Application site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.1) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.1) View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Pnuemonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Animal bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.1) View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.1) View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.1) View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.1) View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.1) View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.1) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.1) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.1) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.1) View
Sjogren's syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.1) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.1) View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.1) View