Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:05 PM
Ignite Modification Date: 2025-12-25 @ 2:06 PM
NCT ID: NCT00470366
Description: None
Frequency Threshold: 5
Time Frame: Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
Study: NCT00470366
Study Brief: Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell 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
Paclitaxel, Ifosfamide, and Cisplatin -Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles. pegfilgrastim cisplatin ifosfamide paclitaxel 5 None 34 60 60 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Allergy/Immunology, other SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Atrial tachycardia/Paroxysmal Atrial Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac General, other SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chyle or lymph leakage SYSTEMATIC_ASSESSMENT Vascular disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine SYSTEMATIC_ASSESSMENT Investigations None View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever (in the absence of neutropenia) SYSTEMATIC_ASSESSMENT General disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemorrhage, Duodenum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhage, Esophagus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infection w/ Gr 3/4 Neut, Kidney SYSTEMATIC_ASSESSMENT Infections and infestations None View
Leukocytes SYSTEMATIC_ASSESSMENT Investigations None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutrophils/granulocytes SYSTEMATIC_ASSESSMENT Investigations None View
Obstruction, GU - Ureter SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pain - Abdomen NOS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain - Back SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain - Chest/thorax NOS SYSTEMATIC_ASSESSMENT General disorders None View
Pain - Throat/pharynx/larynx SYSTEMATIC_ASSESSMENT General disorders None View
Platelets SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thrombosis/embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytes SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophils/granulocytes SYSTEMATIC_ASSESSMENT Investigations None View
Platelets SYSTEMATIC_ASSESSMENT Investigations None View
ALT SYSTEMATIC_ASSESSMENT Investigations None View
Neuropathy: sensory SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
AST SYSTEMATIC_ASSESSMENT Investigations None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Rash: acne/acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Investigations None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
INR SYSTEMATIC_ASSESSMENT Investigations None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Amylase SYSTEMATIC_ASSESSMENT Investigations None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Mucositis - oral cavity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pain - Joint SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View