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: 2025-12-26 @ 2:42 PM
Ignite Modification Date: 2025-12-26 @ 2:42 PM
NCT ID: NCT03032406
Description: The rationale for combining Arms C+D for certain analyses is because these arms are the same intervention- Arm D was just delayed. These arms are consistent with the protocol and randomization engine.
Frequency Threshold: 5
Time Frame: Patients were assessed for adverse events (AE) on Day 1 of each cycle. Follow-up continued every 6 months for 3 years from the completion of study therapy, including remote follow-up during COVID and for patients at a geographical distance from the study center. On Day 1 and D15 of first two cycles, then Day 1 of remaining cycles, and up to 30 days from completion of treatment.
Study: NCT03032406
Study Brief: CLEVER Pilot Trial: A Phase II Pilot Trial of HydroxyChLoroquine, EVErolimus or the Combination for Prevention of Recurrent 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
HCQ Alone (Arm A) Hydroxychloroquine: Hydroxychloroquine 0 None 1 15 15 15 View
EVE Alone (Arm B) Everolimus: Everolimus 0 None 0 15 15 15 View
Combination HCQ and EVE (Arm C+D) Hydroxychloroquine: Hydroxychloroquine Everolimus: Everolimus 0 None 2 21 21 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lung infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cellulitis of arm SYSTEMATIC_ASSESSMENT Infections and infestations None View
Parainfluenzae virus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Liver function abnormalities (transaminitis) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis/oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia/Weight loss SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Visual changes SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Muscle weakness, limb SYSTEMATIC_ASSESSMENT Nervous system disorders None View
CPK increased SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Electrolyte abnormalities SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Elevated lipids SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
SkinRash/Discomfort SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View