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 @ 11:24 PM
Ignite Modification Date: 2025-12-25 @ 9:09 PM
NCT ID: NCT02754856
Description: Treatment related toxicity was assessed and graded using CTCAE v5
Frequency Threshold: 0
Time Frame: Up to 3 years
Study: NCT02754856
Study Brief: Tremelimumab and Durvalumab in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Durvalumab/Tremelimumab Neoadjuvant tremelimumab 75 mg IV flat dose and durvalumab 1500 mg IV flat dose given pre-operatively for 1 cycle prior to CRC liver metastases resection. Post-operative therapy was at the discretion of the treating physician, and patients were eligible to receive durvalumab 1500 mg IV every 4 weeks for 4 cycles. 1 None 0 23 23 23 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v5 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v5 View
Anemia SYSTEMATIC_ASSESSMENT Investigations CTCAE v5 View
Decreased neutrophil count SYSTEMATIC_ASSESSMENT Investigations CTCAE v5 View
Decreased platelet count SYSTEMATIC_ASSESSMENT Investigations CTCAE v5 View
Decreased white blood cells SYSTEMATIC_ASSESSMENT Investigations CTCAE v5 View
Hypokalemia SYSTEMATIC_ASSESSMENT Investigations CTCAE v5 View
Hyponatremia SYSTEMATIC_ASSESSMENT Investigations CTCAE v5 View
Increased alanine aminotransferase SYSTEMATIC_ASSESSMENT Investigations CTCAE v5 View
Increased alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations CTCAE v5 View
Increased aspartate aminotransferase SYSTEMATIC_ASSESSMENT Investigations CTCAE v5 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v5 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE v5 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE v5 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE v5 View
Serum amylase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v5 View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v5 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v5 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v5 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v5 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v5 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE v5 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v5 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE v5 View
Hypotention SYSTEMATIC_ASSESSMENT General disorders CTCAE v5 View
Anxiety SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE v5 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v5 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v5 View
Oral mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v5 View
Rash (maculo-papular) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v5 View
Rash (acneiform) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v5 View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v5 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v5 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v5 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v5 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v5 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v5 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v5 View