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 @ 2:19 PM
Ignite Modification Date: 2025-12-25 @ 12:56 PM
NCT ID: NCT02869295
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days.
Study: NCT02869295
Study Brief: A Phase 1/2 Multicenter Dose Escalation and Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NKTR-214 0.003 mg/kg q21d NKTR-214 given at a dose of 0.003 mg/kg every 21 days 2 None 2 4 4 4 View
NKTR-214 0.006 mg/kg q21d NKTR-214 given at a dose of 0.006 mg/kg every 21 days 3 None 5 11 11 11 View
NKTR-214 0.006 mg/kg q14d NKTR-214 given at a dose of 0.006 mg/kg every 14 days 2 None 4 6 6 6 View
NKTR-214 0.009 mg/kg q21d NKTR-214 given at a dose of 0.009 mg/kg every 21 days 1 None 3 6 6 6 View
NKTR-214 0.012 mg/kg q21d NKTR-214 given at a dose of 0.012 mg/kg every 21 days 0 None 1 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Anemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Metastases to Central Nervous System SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT General disorders None View
Ascites SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders None View
Gastroduodenal Hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lipase Increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Liver Function Test Abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Lower Gastrointestinal Hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cytokine Release Syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypersensitivity SYSTEMATIC_ASSESSMENT General disorders None View
Humerus Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension Grade 1-2 SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Headache Grade 1-2 SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anemia Grade 1-2 SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constipation Grade 1-2 SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peripheral Edema Grade 1-2 SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal Pain Grade 1-2 SYSTEMATIC_ASSESSMENT General disorders None View
Pleural Effusion Grade 1-2 SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Confusional State Grade 1-2 SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Infusion Related Reaction Grade 1-2 SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Presyncope Grade 1-2 SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fatigue Grade 1-2 SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fatigue Grade 1-2 SYSTEMATIC_ASSESSMENT General disorders None View
Flu-Like Symptoms Grade 1-2 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pruritus Grade 1-2 SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Decreased Appetite Grade 1-2 SYSTEMATIC_ASSESSMENT General disorders None View
Rash Grade 1-2 SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arthralgia Grade 1-2 SYSTEMATIC_ASSESSMENT General disorders None View
Cough Grade 1-2 SYSTEMATIC_ASSESSMENT General disorders None View
Nausea Grade 1-2 SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea Grade 1-2 SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea Grade 1-2 SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion Grade 1-2 SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dizziness Grade 1-2 SYSTEMATIC_ASSESSMENT General disorders None View
Myalgia Grade 1-2 SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting Grade 1-2 SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight Decreased Grade 1-2 SYSTEMATIC_ASSESSMENT General disorders None View
Flushing Grade 1-2 SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety Grade 1-2 SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Blood creatine increased Grade 1-2 SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Cytokine Release Syndrome Grade 1-2 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dry Skin Grade 1-2 SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspepsia Grade 1-2 SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Generalized Edema Grade 1-2 SYSTEMATIC_ASSESSMENT General disorders None View
Muscular Weakness Grade 1-2 SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain Extremity Grade 1-2 SYSTEMATIC_ASSESSMENT General disorders None View
Syncope Grade 3-5 SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Headache Grade 3-5 SYSTEMATIC_ASSESSMENT General disorders None View
Anemia Grade 3-5 SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Metastases to Central Nervous System Grade 3-5 SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Constipation Grade 3-5 SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peripheral Edema Grade 3-5 SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal Pain Grade 3-5 SYSTEMATIC_ASSESSMENT General disorders None View
Pleural Effusion Grade 3-5 SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Confusional State Grade 3-5 SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Infusion Related Reaction Grade 3-5 SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Presyncope Grade 3-5 SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Brain Edema Grade 3-5 SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Disease Progression Grade 3-5 SYSTEMATIC_ASSESSMENT General disorders None View
Gastroduodenal Hemorrhage Grade 3-5 SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemiparesis Grade 3-5 SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypovolemic Shock Grade 3-5 SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lipase Increased Grade 3-5 SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Liver Function Test Abnormal Grade 3-5 SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lower Gastrointestinal Hemorrhage Grade 3-5 SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Metastases to Meninges Grade 3-5 SYSTEMATIC_ASSESSMENT General disorders None View
Sepsis Grade 3-5 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypotension Grade 3-5 SYSTEMATIC_ASSESSMENT Cardiac disorders None View