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 @ 2:08 AM
Ignite Modification Date: 2025-12-26 @ 12:34 AM
NCT ID: NCT04964960
Description: None
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT04964960
Study Brief: Pembro+Chemo in Brain Mets
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pembrolizumab with standard of care chemotherapy treatment Patients will receive 200mg or 400mg of Pembrolizumab (standard of care dosing at the discretion of treating physician) over thirty minutes on day 1 every three or six weeks with standard of care chemotherapy treatment (carboplatin, pemetrexed, paclitaxel, nab-paclitaxel). Pembrolizumab: Pembrolizumab is an immunotherapy that can help fight certain cancers. Nab paclitaxel: Nab-paclitaxel is a taxane derivative that is an albumin-bound paclitaxel nanoparticle formulation that promotes microtubule assembly. Paclitaxel: Paclitaxel is a taxane derivative that promotes microtubule assembly by enhancing the action of tubulin dimers, stabilizing existing microtubules, and inhibiting their disassembly, interfering with the late G2 mitotic phase, and inhibiting cell replication. Pemetrexed: Pemetrexed is an antifolate agent that disrupts folate-dependent metabolic processes essential for cell replication. Carboplatin: Carboplatin is a platinum compound alkylating agent which covalently binds to DNA and interferes with the function of DNA by producing interstrand DNA cross-links. 1 None 0 3 2 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac disorders - Other SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Weight gain SYSTEMATIC_ASSESSMENT Investigations None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Spasticity SYSTEMATIC_ASSESSMENT Nervous system disorders None View