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 @ 4:06 AM
Ignite Modification Date: 2025-12-26 @ 3:02 AM
NCT ID: NCT03531320
Description: Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.
Frequency Threshold: 5
Time Frame: The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment.
Study: NCT03531320
Study Brief: Study of D07001-Softgel Capsules in Subjects With Gastrointestinal Cancer in Dose-Escalation Phase and in Subjects With Biliary Tract Cancer in Dose-Expansion Phase
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part 1:Dose-Escalation Phase Level 1 40 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride 0 None 0 4 2 4 View
Part 1:Dose-Escalation Phase Level 2 60 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride 0 None 0 3 2 3 View
Part 1:Dose-Escalation Phase Level 3 80 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride 0 None 0 3 3 3 View
Part 1:Dose-Escalation Phase Level 4 120 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride 0 None 2 6 6 6 View
Part 1:Dose-Escalation Phase Level 5 100 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride 0 None 1 3 3 3 View
Part 2: Dose-Expansion Phase (Phase 2) higher dose-expansion of D07001-softgel capsules lower dose-expansion of D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride 0 None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hepatotoxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Faitigue SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View