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 @ 9:24 PM
Ignite Modification Date: 2025-12-25 @ 7:10 PM
NCT ID: NCT02097732
Description: Both arms were combined in the reporting of Adverse Events because both arms received the same two interventions.
Frequency Threshold: 0
Time Frame: Adverse events were collected up to 6 months after study start. All-cause mortality is observed up to 5 years.
Study: NCT02097732
Study Brief: Ipilimumab Induction in Patients With Melanoma Brain Metastases Receiving Stereotactic Radiosurgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ipilimumab and SRS (Induction) Patients will receive 2 doses of ipilimumab, which is given once every 3 weeks, prior to stereotactic radiosurgery (SRS), followed by 2 more doses of ipilimumab, for a total of 4 doses. OR (No Induction) Participants will undergo stereotactic radiosurgery (SRS) followed 2-3 weeks later by ipilimumab, which is given once every 3 weeks for a total of 4 doses. Ipilimumab: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses. Stereotactic Radiosurgery: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours. 1 None 0 4 4 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased None Investigations None View
Concentration impairment None Psychiatric disorders None View
Constipation None Gastrointestinal disorders None View
Creatinine increased None Investigations None View
Depression None Psychiatric disorders None View
Diarrhea None Gastrointestinal disorders None View
Dizziness None Nervous system disorders None View
Edema limbs None Vascular disorders None View
Fatigue None General disorders None View
Fever None General disorders None View
Flu like symptoms None Infections and infestations None View
Headache None Nervous system disorders None View
Hot flashes None Nervous system disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Decreased T4 None Investigations None View
Vitamin D Deficiency None Investigations None View
Low Testosterone None Investigations None View
Elevated LDH None Investigations None View
Lymphocyte count decreased None Blood and lymphatic system disorders None View
Muscle weakness left-sided None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Nail discoloration None Skin and subcutaneous tissue disorders None View
Nausea None Gastrointestinal disorders None View
Neck pain None Musculoskeletal and connective tissue disorders None View
Pain in extremity None Musculoskeletal and connective tissue disorders None View
Periorbital edema None Vascular disorders None View
Platelet count decreased None Blood and lymphatic system disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Rash acneiform None Skin and subcutaneous tissue disorders None View
Rash maculo-papular None Skin and subcutaneous tissue disorders None View
Tremor None Nervous system disorders None View
Upper respiratory infection None Respiratory, thoracic and mediastinal disorders None View
Vertigo None Nervous system disorders None View
Vomiting None Gastrointestinal disorders None View