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 @ 2:24 AM
Ignite Modification Date: 2025-12-26 @ 12:57 AM
NCT ID: NCT03858634
Description: The adverse event data are presented by combined cohorts for public reporting purposes because the low numbers of participants in the individual disease-specific cohorts may cause re-identification concerns if presented separately.
Frequency Threshold: 0
Time Frame: From first dose of study treatment through the end-of-study visit (Week 18).
Study: NCT03858634
Study Brief: A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
KPL-716 KPL-716 weekly for 8 weeks 0 None 1 39 15 39 View
Placebo Placebo weekly for 8 weeks 0 None 0 19 11 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Lymphangitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Pityriasis rosea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Cardiac murmur SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Electrocardioagram T wave abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Muscle contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Vitamin B12 deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 21.1 View