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 @ 5:40 PM
Ignite Modification Date: 2025-12-25 @ 3:10 PM
NCT ID: NCT05361668
Description: AE results were reported based on the dose assigned at randomization (40 mg and 80 mg paltusotine), regardless of the actual dose received at the time of AE reporting. Dose changes at Weeks 2 or 4 were allowed for symptom control (increase) or poor tolerability (decrease).
Frequency Threshold: 5
Time Frame: Adverse event data were collected over the 8 weeks of the RTP phase, and an EOS Visit was to occur to collect the safety data and other assessments, 28 days after last dose of study drug and was required for subjects who completed the study or early terminated. TEAE data were summarized from first dose date until last dose date (end of RTP or early term) plus 28 days (Safety follow up).
Study: NCT05361668
Study Brief: Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
40 mg Paltusotine Randomized: 40 mg paltusotine: Two 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg) 0 None 2 18 16 18 View
80 mg Paltusotine Randomized: 80 mg paltusotine: Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg) 1 None 2 18 15 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Large intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Infections and infestations SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View