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 @ 4:07 PM
Ignite Modification Date: 2025-12-25 @ 2:08 PM
NCT ID: NCT00404066
Description: None
Frequency Threshold: 0
Time Frame: up to 5 years
Study: NCT00404066
Study Brief: Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ 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
Neoadjuvant Chemotherapy Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year. 2 None 0 21 21 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Irregular menses NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hand-foot-skin reactions NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nail bed changes NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dysphagia (mouth pain) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Adrenal insufficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Peripheral neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arthralgia (joint pain) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain, general NON_SYSTEMATIC_ASSESSMENT General disorders None View