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 @ 12:08 AM
Ignite Modification Date: 2025-12-25 @ 10:08 PM
NCT ID: NCT00570258
Description: None
Frequency Threshold: 0
Time Frame: 5 years
Study: NCT00570258
Study Brief: Randomized, Double Blind Multicenter Phase II Study of Time to Progression on Fulvestrant in Combination With Erlotinib or Placebo in Hormone Receptor-Positive Metastatic Breast Cancer (MBC) Subjects Who Progressed on First Line Hormonal 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
Fulvestrant Plus Erlotinib Fulvestrant: 250 mg IM Q 4 weeks Erlotinib: 150 mg PO QD Fulvestrant: Fulvestrant: 250 mg IM Q 4 weeks erlotinib: 150 mg PO QD 3 None 3 15 5 15 View
Fulvestrant Plus Placebo Fulvestrant: 250 mg IM Q 4 weeks Placebo: 150 mg PO QD Fulvestrant: 250 mg IM Q 4 weeks Placebo: Placebo 150 mg PO QD 8 None 2 12 3 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
fever of unknown origin SYSTEMATIC_ASSESSMENT Immune system disorders None View
possible heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
pulmonary embolus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
anorexia SYSTEMATIC_ASSESSMENT General disorders None View
alopecia SYSTEMATIC_ASSESSMENT General disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
nausea/vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
pain SYSTEMATIC_ASSESSMENT General disorders None View
dizziness SYSTEMATIC_ASSESSMENT General disorders None View
cough SYSTEMATIC_ASSESSMENT General disorders None View
bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
pruritis SYSTEMATIC_ASSESSMENT General disorders None View
dyspnea SYSTEMATIC_ASSESSMENT General disorders None View