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 @ 12:04 AM
Ignite Modification Date: 2025-12-25 @ 10:02 PM
NCT ID: NCT04108858
Description: This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
Frequency Threshold: 5
Time Frame: 7 months
Study: NCT04108858
Study Brief: Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase 1, Dose Level 1 Copanlisib 60 mg given D1 and D8 of each 21 day cycle +Trastuzumab, pertuzumab given D1 of each 21 day cycle 0 None 0 2 2 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
aPTT SYSTEMATIC_ASSESSMENT Investigations None View
Alk phos SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
bruising SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspena SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
oral mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Papulopustular SYSTEMATIC_ASSESSMENT Infections and infestations None View