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 @ 12:01 AM
Ignite Modification Date: 2025-12-25 @ 9:59 PM
NCT ID: NCT03009058
Description: Adverse events (including those reported spontaneously by the patient or observed by the Investigator) were recorded from the time of informed consent. All adverse events were followed until resolution, death or 30 days after the End of Study/Withdrawal visit (whichever came first). Study treatment related serious adverse events (SAEs) were recorded regardless of time from last dose.
Frequency Threshold: 1
Time Frame: Adverse events were collected from the time of consent until 28(±7 days) received at week 10 date which is around 3 months after the last dose of IMM-101. Serious Adverse Events were followed to resolution irrespective of the date of the last dose
Study: NCT03009058
Study Brief: Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable 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
IMM-101 in Combination With Anti PDL1 in Melanoma Patients diagnosed with metastatic melanoma who were receiving an anti-PD-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study. 0 None 0 2 1 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (20) View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (20) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (20) View