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 @ 10:14 PM
Ignite Modification Date: 2025-12-25 @ 7:48 PM
NCT ID: NCT01288235
Description: Toxicity assessments were done using NCI Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Frequency Threshold: 0
Time Frame: All adverse events, both serious and non-serious, and deaths were collected from the initiation of study intervention, during treatment, and annually for up to 5 years after the completion of radiation treatment.
Study: NCT01288235
Study Brief: Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Proton Radiotherapy Proton Radiotherapy Proton radiotherapy: 5 days a week 15 None 2 100 98 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lymphocyte Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Ear and labyrinth disorders - Other SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
External ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Middle ear inflammation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Gastrointestinal disorders - Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
General disorders and administration site conditions - Other SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood gonadotrophin abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Blood prolactin abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Growth hormone abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Investigations - Other SYSTEMATIC_ASSESSMENT Investigations None View
Weight gain SYSTEMATIC_ASSESSMENT Investigations None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View
Growth suppression SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Kyphosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal and connective tissue disorder - Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
IVth nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abducens nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Concentration impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Facial muscle weakness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Facial nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Muscle weakness left-sided SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Muscle weakness right-sided SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nervous system disorders - Other SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nystagmus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Oculomotor nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Psychiatric disorders - Other SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Irregular menstruation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory, thoracic and mediastinal disorders - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Delayed puberty SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Endocrine disorders - Other SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypoparathyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Precocious puberty SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye disorders - Other SYSTEMATIC_ASSESSMENT Eye disorders None View
Eyelid function disorder SYSTEMATIC_ASSESSMENT Eye disorders None View
Optic nerve disorder SYSTEMATIC_ASSESSMENT Eye disorders None View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Photosensitivity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin and subcutaneous tissue disorders - Other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vascular disorders - Other SYSTEMATIC_ASSESSMENT Vascular disorders None View