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 @ 12:00 AM
Ignite Modification Date: 2025-12-25 @ 9:57 PM
NCT ID: NCT02447458
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 5
Time Frame: First dose of study drug to 30 days post last dose (Up to Day 31)
Study: NCT02447458
Study Brief: MLN3126 Single Rising Dose Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MLN3126 600 mg MLN3126 600 mg tablets, orally, fasting, once on Day 1. None None 0 6 0 6 View
MLN3126 1000 mg MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1. None None 0 6 1 6 View
MLN3126 1500 mg MLN3126 1500 mg tablets, orally, fasting, once on Day 1. None None 0 6 0 6 View
MLN3126 2000 mg MLN3126 2000 mg tablets, orally, fasting once on Day 1. None None 0 6 1 6 View
Placebo Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1. None None 0 10 1 10 View
MLN3126 1000 mg (Fed) MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1. None None 0 5 1 5 View
Placebo (Fed) Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1. None None 0 2 0 2 View
MLN3126 300 mg MLN3126 300 mg tablets, orally, fasting, once on Day 1. None None 0 5 1 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View