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 @ 12:18 AM
Ignite Modification Date: 2025-12-25 @ 10:21 PM
NCT ID: NCT02955758
Description: None
Frequency Threshold: 4
Time Frame: up to 3 years
Study: NCT02955758
Study Brief: Pembrolizumab in Patients With Metastatic Non-squamous Non-small Cell Lung 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
Treatment (Pembrolizumab) Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. 2 None 9 25 23 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Worsening dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Recurrence of bilateral pleural effusions SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
worsening of oncologic disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Bacterial pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Worsening bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Worsening pericardial effusion with Tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
pain SYSTEMATIC_ASSESSMENT General disorders None View
altered mental status SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Craniotomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Worsening decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Right heel infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash acneiform on shoulder SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash acneiform on face SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash acneiform SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash acneiform on chest SYSTEMATIC_ASSESSMENT Infections and infestations None View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash acneiform on back SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash acneiform on buttocks SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash acneiform on feet SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash acneiform on arms SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neck pain SYSTEMATIC_ASSESSMENT Infections and infestations None View
Worsening muscle weakness SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rib pain SYSTEMATIC_ASSESSMENT Infections and infestations None View
Left shoulder pain SYSTEMATIC_ASSESSMENT Infections and infestations None View
Post-surgical chest pain SYSTEMATIC_ASSESSMENT Infections and infestations None View
Intermittent RUE muscle cramps SYSTEMATIC_ASSESSMENT Infections and infestations None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cramps (arms) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cramps (legs) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Weakness in right hand SYSTEMATIC_ASSESSMENT Infections and infestations None View
Intermittent achiness SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arthritic pain in hands SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bilateral pleural effusions SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anterior chest pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Possible tuberculosis reactivation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Lower extremity edema SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Neuropathy SYSTEMATIC_ASSESSMENT General disorders None View
Worsening fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Post-biopsy pain (left rib) SYSTEMATIC_ASSESSMENT General disorders None View
Neuropathy (Left chest wall) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrovascular ischemia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Worsening headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itchy skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders None View
Worsening hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders None View
Possible temporal arteritis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Gynecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Left foot discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Worsening left hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right-sided muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Renal failure and altered mental status SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Runny nose (allergies) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Syncope SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Malaise SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Venous distention SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Contrast allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Elevated AST SYSTEMATIC_ASSESSMENT Investigations None View
Elevated creatinine SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophilia SYSTEMATIC_ASSESSMENT Investigations None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Worsening diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lower back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
General back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left sided rib pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
intermittent blurry vision SYSTEMATIC_ASSESSMENT Eye disorders None View
visual changes SYSTEMATIC_ASSESSMENT Eye disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Worsening abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Worsening vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Post-operative abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Worsening back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Upper back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View