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 @ 2:40 AM
Ignite Modification Date: 2025-12-26 @ 1:19 AM
NCT ID: NCT05694533
Description: All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.
Frequency Threshold: 5
Time Frame: 22 days
Study: NCT05694533
Study Brief: Study of Potential CYP3A4 Induction by INDV-2000 in Healthy Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Midazolam Midazolam alone 0 None 0 20 7 20 View
INDV-2000 INDV-2000 alone 0 None 0 20 12 20 View
Midazolam + INDV-2000 INDV-2000 co-administered with midazolam 0 None 0 20 3 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders None View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View