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 @ 10:22 PM
Ignite Modification Date: 2025-12-25 @ 7:54 PM
NCT ID: NCT03025035
Description: None
Frequency Threshold: 0
Time Frame: Adverse events are collected for up to two years of total study participation.
Study: NCT03025035
Study Brief: Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast 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
Pembrolizumab + Olaparib This is an open-label, single-arm pilot study of pembrolizumab (study drug) in combination with Olaparib in 20 subjects with advanced BRCA mutation or HDR-defect associated breast cancer having progressed through at least a standard first line therapy. Pembrolizumab: Pembrolizumab IV solution administered on Day 1 of each 3-week cycle Olaparib: Olaparib administered orally twice a day 6 None 0 11 11 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood Bilirubin Increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Concentration Impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine increased SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema Limbs SYSTEMATIC_ASSESSMENT General disorders None View
Eye disorders - Other SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Eyelid Function Disorder SYSTEMATIC_ASSESSMENT Eye disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Flank Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gastroesophagael Reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Joint Range of Motion Decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Mucositis Oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Oral Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other- Pain at Biopsy Site SYSTEMATIC_ASSESSMENT General disorders None View
Other- Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Other- Muscle Cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Postnasal Drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stomach Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thromboembolic Event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other- Injection Site Pain (Intermittent) SYSTEMATIC_ASSESSMENT General disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View