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 @ 7:09 PM
Ignite Modification Date: 2025-12-25 @ 4:42 PM
NCT ID: NCT02057757
Description: The definition of AEs and SAEs used to collect AE event information for this study does not differ from the clinicaltrials.gov definitions. The study Investigators evaluated AEs with respect to Seriousness (as per the protocol), Severity (grading), and Causality according to the "DAIDS (Division of AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events" Version 1.0, December 2004: (Clarification August 2009)
Frequency Threshold: 5
Time Frame: AEs were recorded for each subject starting at completing the Informed Consent process and continuing until the subject completed study, or until resolution of the adverse event as recorded by the clinical site (up to Day 28).
Study: NCT02057757
Study Brief: Nitazoxanide Versus Placebo for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nitazoxanide (NTZ) Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets. Nitazoxanide (NTZ): Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days. 2 None 6 130 26 130 View
Placebo Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets. Placebo: Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days. 1 None 3 127 26 127 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View
Aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Pneumonia Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Immune Reconstitution Inflammatory Syndrome Associated Kaposi's Sarcoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (10.0) View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.1) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.1) View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (16.1) View