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 @ 4:09 PM
Ignite Modification Date: 2025-12-25 @ 2:09 PM
NCT ID: NCT04631666
Description: Participants were queried for Adverse Events at all study visits
Frequency Threshold: 0
Time Frame: Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Study: NCT04631666
Study Brief: SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Infusion
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1A: Healthy, 2.5 mg/kg SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 2.5 mg/kg DZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion 0 None 0 3 2 3 View
1B: Healthy, 10 mg/kg SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 10 mg/kg DZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion 0 None 0 3 1 3 View
2C: Infected, 40 mg/kg SARS-CoV-2-infected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 40 mg/kg DZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion 0 None 0 3 1 3 View
2D: Infected, 40 mg/kg SARS-CoV-2-infected volunteers randomized to receive an intravenous infusion of DZIF-10c at a dose of 40 mg/kg (blinded) DZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion 0 None 0 26 18 26 View
2D: Infected, Placebo SARS-CoV-2-infected volunteers randomized to receive an intravenous infusion of placebo (blinded) Placebo: Sterile normal saline 0 None 0 13 10 13 View
1C: Healthy, 40 mg/kg SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 40 mg/kg DZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion 0 None 0 3 2 3 View
1D: Healthy, 80 mg/kg SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose higher than 40 mg/kg DZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion 0 None 0 6 0 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyposmia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypogeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Parosmia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ageusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tympanic membrane perforation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Thyroid mass SYSTEMATIC_ASSESSMENT Endocrine disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View