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 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:36 PM
NCT ID: NCT01112293
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected from time of first administration of study product until 30 days of the last administration of study product, approximately 1 year and 5 months.
Study: NCT01112293
Study Brief: Anti-TGF Monoclonal Antibody (GC1008) in Relapsed Malignant Pleural Mesothelioma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Investigational Drug infusion-for Safety and Effectiveness Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment. GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively. 12 None 6 14 12 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v.4.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v.4.0 View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v.4.0 View
Fatigue SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v.4.0 View
Thrombosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v.4.0 View
Disease Progression SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v.4.0 View
Fever SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v.4.0 View
None SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v.4.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v.4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v.4.0 View
Fatigue SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v.4.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v.4.0 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v.4.0 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v.4.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v.4.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v.4.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v.4.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v.4.0 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v.4.0 View
Back Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications NCI CTCAE v.4.0 View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v.4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v.4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v.4.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v.4.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v.4.0 View
Mucosal Infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v.4.0 View
None SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v.4.0 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v.4.0 View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v.4.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v.4.0 View
Edema Limbs SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v.4.0 View
Chest Wall Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v.4.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v.4.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v.4.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v.4.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v.4.0 View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v.4.0 View