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 @ 4:44 PM
Ignite Modification Date: 2025-12-25 @ 2:31 PM
NCT ID: NCT01602666
Description: Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Frequency Threshold: 0
Time Frame: From initiation of induction of therapy to the date of last follow-up, approximately 3 years. For most subjects the adverse events were observed while on active treatment or shortly thereafter.
Study: NCT01602666
Study Brief: Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System 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
Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks. 13 None 5 107 84 107 View
Stratum 2 Localized Germinoma Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or continued CR (CCR) undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients found to have fibrosis, scar, mature teratoma, or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with stable disease (SD) or PR with \> 0.5 cm (suprasellar) or \> 1 cm (pineal) but =\< 1.5 cm residual disease do not undergo second-look surgery and undergo 3DRT or IMRT QD 5 days a week for 4 weeks. 2 None 1 137 107 137 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anaphylaxis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Avascular necrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blood and lymphatic system disorders - Other- Specify SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
CPK increased SYSTEMATIC_ASSESSMENT Investigations None View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cerebrospinal fluid leakage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Edema cerebral SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Endocrine disorders - Other- Specify SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
GGT increased SYSTEMATIC_ASSESSMENT Investigations None View
Growth suppression SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
INR increased SYSTEMATIC_ASSESSMENT Investigations None View
Infections and infestations - Other- Specify SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Irritability SYSTEMATIC_ASSESSMENT General disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lymph gland infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations None View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Meningismus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neoplasms benign- malignant and unspecified (incl cysts and polyps) - Other- Specify SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Nervous system disorders - Other- Specify SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Photosensitivity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Renal and urinary disorders - Other- Specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight gain SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View