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 @ 11:28 PM
Ignite Modification Date: 2025-12-25 @ 9:15 PM
NCT ID: NCT03789656
Description: Some participants received uptitrated dose during the treatment period and are therefore counted in multiple dosing groups.
Frequency Threshold: 4
Time Frame: Participants were monitored until the end of the 4-week follow-up period (up to 17 weeks total).
Study: NCT03789656
Study Brief: An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dose 5 mg Adverse event occurred when subject was receiving 5 mg dose paltusotine 0 None 0 2 0 2 View
Dose 10 mg Adverse event occurred when subject was receiving 10 mg dose paltusotine 0 None 0 47 23 47 View
Dose 20 mg Adverse event occurred when subject was receiving 20 mg dose paltusotine 0 None 1 43 24 43 View
Dose 30 mg Adverse event occurred when subject was receiving 30 mg dose paltusotine 0 None 0 37 15 37 View
Dose 40 mg Adverse event occurred when subject was receiving 40 mg dose paltusotine 0 None 0 32 19 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Peripheral swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Sleep apnea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View