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 @ 4:18 AM
Ignite Modification Date: 2025-12-26 @ 3:18 AM
NCT ID: NCT02783820
Description: None
Frequency Threshold: 0
Time Frame: Until Day 28
Study: NCT02783820
Study Brief: Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048, Part A
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pooled Placebo Pooled placebo from all cohorts (2 per cohort = 6) 0 None 1 6 4 6 View
MMV390048 40 mg MMV390048 40 mg, tablets, single dose 0 None 0 6 0 6 View
MMV390048 80 mg MMV390048 80 mg, tablets, single dose 0 None 0 6 4 6 View
MMV390048 120 mg MMV390048 120 mg, tablets, single dose 0 None 0 6 5 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abortion spontaneous NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders None View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Medical device site reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Sterile pyuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Suture insertion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View