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 @ 5:31 PM
Ignite Modification Date: 2025-12-25 @ 3:04 PM
NCT ID: NCT00902668
Description: None
Frequency Threshold: 5
Time Frame: From Baseline to Off Study. 7 months or less
Study: NCT00902668
Study Brief: Lovastatin in Reducing Side Effects After Radiation Therapy in Women With 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
Supportive Care (Lovastatin) Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. None None 0 3 2 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rash: dermatitis associated with radiation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Hyperpigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Pruritus/itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Rash/desquamation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Fatigue (asthenia, lethargy, malaise) NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Dry mouth/salivary gland (xerostomia) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Taste alteration (dysgeusia) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Infection with unknown ANC - Vagina NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTC V3 View
Fibrosis-cosmesis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTC V3 View
Pain - Breast NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Pain - Extremity-limb NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View