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 @ 3:01 AM
Ignite Modification Date: 2025-12-26 @ 1:41 AM
NCT ID: NCT04120233
Description: None
Frequency Threshold: 0
Time Frame: From the start of study drug administration up to 7-day follow-up
Study: NCT04120233
Study Brief: MW151-101: First-in-human Study of MW151
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants will receive placebo. Placebo: Matched placebo administered orally 0 None 0 10 6 10 View
Dose 1 Participants will receive 10 mg of MW151. MW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally 0 None 0 6 0 6 View
Dose 2 Participants will receive 20mg of MW151. MW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally 0 None 0 6 4 6 View
Dose 3 Participants will receive 40mg of MW151. MW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally 0 None 0 6 3 6 View
Dose 4 Participants will receive 80mg of MW151. MW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally 0 None 0 6 3 6 View
Dose 5 Participants will receive 160mg of MW151. MW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally 0 None 0 6 2 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Asymptomatic bacteriuria SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infusion site pain SYSTEMATIC_ASSESSMENT General disorders None View
Blood pressure diastolic increased SYSTEMATIC_ASSESSMENT Investigations None View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations None View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View