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 @ 9:16 PM
Ignite Modification Date: 2025-12-25 @ 7:05 PM
NCT ID: NCT00999804
Description: Adverse events experienced by participants will be collected and reported from initiation of study medication, throughout the study, and within 30 days of the last dose of study medication.
Frequency Threshold: 5
Time Frame: 7 months
Study: NCT00999804
Study Brief: Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
24-week Arm Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy. Lapatinib: 1000 mg by mouth daily Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only) Trastuzumab: 6 mg/kg intravenously, every 3 weeks None None 3 85 61 85 View
12-week Arm Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy. Lapatinib: 1000 mg by mouth daily Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only) Trastuzumab: 6 mg/kg intravenously, every 3 weeks None None 1 43 26 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.0 View
Elevated AST SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE v4.0 View
Breast infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.0 View
Renal calculi SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v4.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.0 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v4.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v4.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Nusea SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.0 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View