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 @ 4:39 AM
Ignite Modification Date: 2025-12-26 @ 3:42 AM
NCT ID: NCT01457118
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data was collected over the course of the study approximately 6 years
Study: NCT01457118
Study Brief: An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
145 mg/m2 NKTR-102: A 90 minute IV infusion of 145 mg/m2 16 None 5 20 20 20 View
120 mg/m2 NKTR-102: A 90 minute IV infusion of 120 mg/m2 3 None 1 4 4 4 View
95 mg/m2 NKTR-102: A 90 minute IV infusion of 95 mg/m2 0 None 0 1 1 1 View
50 mg/m2 NKTR-102: A 90 minute IV infusion of 50 mg/m2 0 None 1 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpex simplex encephalitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Appendix Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cancer Pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Renal Failure Acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Total Number of TESAEs SYSTEMATIC_ASSESSMENT General disorders None View
Peritonitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
# of subjects with Anemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
# of subjects with Neutropenia SYSTEMATIC_ASSESSMENT Immune system disorders None View
# of subjects with Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
# of subjects with Vision Blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
# of subjects with Photophobia SYSTEMATIC_ASSESSMENT General disorders None View
# of subjects with Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
# of subjects with Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
# of subjects with Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
# of subjects with Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
# of subjects with Abdominal Pain SYSTEMATIC_ASSESSMENT General disorders None View
# of subjects with Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
# of subjects with Upper Abdominal Pain SYSTEMATIC_ASSESSMENT General disorders None View
# of subjects with Ascites SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
# of subjects with Dry Mouth SYSTEMATIC_ASSESSMENT General disorders None View
# of subjects with Hypoesthesia Oral SYSTEMATIC_ASSESSMENT Nervous system disorders None View
# of subjects with Mouth Ulceration SYSTEMATIC_ASSESSMENT Infections and infestations None View
# of subjects with Stomatitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
# of subjects with Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
# of subjects with Oedema Peripheral SYSTEMATIC_ASSESSMENT Cardiac disorders None View
# of subjects with Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
# of subjects with Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
# of subjects with Urinary Tract Infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
# of subjects with Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
# of subjects with Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
# of subjects with Abdominal Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
# of subjects with Gingival Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
# of subjects with Herpes Simplex Encephalitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
# of subjects with Weight Decreased SYSTEMATIC_ASSESSMENT General disorders None View
# of subjects with Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Immune system disorders None View
# of subjects with Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
# of subjects with White Blood Cell count decreased SYSTEMATIC_ASSESSMENT Immune system disorders None View
# of subjects with Activated Partial Thromboplastin Time Prolonged SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
# of subjects with Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
# of subjects with Blood Bilirubin Increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
# of subjects with Liver Function Test Abnormal SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
# of subjects with Prothrombin Time Prolonged SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
# of subjects with Decreased Appetite SYSTEMATIC_ASSESSMENT General disorders None View
# of subjects with Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
# of subjects with Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
# of subjects with Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
# of subjects with Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
# of subjects with Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
# of subjects with Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
# of subjects with Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
# of subjects with Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
# of subjects with Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
# of subjects with Flank Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
# of subjects with Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
# of subjects with Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
# of subjects with Appendix Pain SYSTEMATIC_ASSESSMENT General disorders None View
# of subjects with Cancer Pain SYSTEMATIC_ASSESSMENT General disorders None View
# of subjects with Aphonia SYSTEMATIC_ASSESSMENT General disorders None View
# of subjects with Dysgeusia SYSTEMATIC_ASSESSMENT General disorders None View
# of subjects with Hypoesthesia SYSTEMATIC_ASSESSMENT General disorders None View
# of subjects with Depressed Mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
# of subjects with Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
# of subjects with Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
# of subjects with Acute Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
# of subjects with Vaginal Hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
# of subjects with Oropharyngeal Pain SYSTEMATIC_ASSESSMENT General disorders None View
# of subjects with Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
# of subjects with Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
# of subjects with Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
# of subjects with Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
# of subjects with Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
# of subjects with Pulmonary Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
# of subjects with Decubitus Ulcer SYSTEMATIC_ASSESSMENT Infections and infestations None View
# of subjects with Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
# of subjects with Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
# of subjects with Alopecia SYSTEMATIC_ASSESSMENT General disorders None View
# of subjects with Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
# of subjects with Pelvic Venous Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
# of subjects with Peritonitis Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations None View
# of subjects with Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
# of subjects with Blood Creatine Increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
# of subjects with Hypomagenesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
# of subjects with Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View