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 @ 11:37 PM
Ignite Modification Date: 2025-12-25 @ 9:27 PM
NCT ID: NCT00984256
Description: None
Frequency Threshold: 5
Time Frame: 7 days before challenge until end of the study (Day 90)
Study: NCT00984256
Study Brief: Weekly Dosing of Malarone ® for Prevention of Malaria
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Drug Partially randomized, double-blind, placebo-controlled trial using a human Plasmodium falciparum challenge to evaluate malaria chemoprophylaxis of Malarone in 36 healthy adults. Subjects were enrolled in 1 of 2 cohorts based on subject preference. Thirty subjects were placed in the prophylaxis cohort (Cohort 1) and 6 subjects were placed in the control cohort (Cohort 2) 5 treatment groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge. Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge None None 0 29 16 29 View
Control no malarone prophylaxis received None None 0 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
None NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
upper respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View