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 @ 11:04 PM
Ignite Modification Date: 2025-12-25 @ 8:34 PM
NCT ID: NCT02919969
Description: A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
Frequency Threshold: 0
Time Frame: All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
Study: NCT02919969
Study Brief: Pembrolizumab in Metastatic Anal 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 Pembrolizumab is administered every 3 week intravenously. Dosage to be determined by physician Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. 24 None 13 32 24 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Infections and Infestations SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract Obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Scrotal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sudden death NOS SYSTEMATIC_ASSESSMENT General disorders None View
Renal and urinary disorders - Other, specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Localized edema SYSTEMATIC_ASSESSMENT General disorders None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin/subcutaneous tissue disorders; Other, specify (mouth sore) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View