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 @ 12:44 AM
Ignite Modification Date: 2025-12-25 @ 10:56 PM
NCT ID: NCT00778167
Description: Patients were evaluated with history, physical examination, vital signs, and blood tests weekly through cycle 1 and on day 1 of each subsequent cycle. Incidence and severity of AEs were collected at each study visit
Frequency Threshold: 5
Time Frame: Weekly through cycle 1 and on day 1 of each subsequent cycle
Study: NCT00778167
Study Brief: Erlotinib Hydrochloride With or Without Cixutumumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung 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
Cohort 2 Cohort 2: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles. None None 0 8 8 8 View
Cohort 1 Cohort 1: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles. None None 0 6 6 6 View
Cohort 3 Cohort 3: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles. None None 0 4 4 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperglycemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Acneiform rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Taste alteration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Rigors/chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Nail changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Muscle cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View