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 @ 7:12 PM
Ignite Modification Date: 2025-12-25 @ 4:47 PM
NCT ID: NCT02142803
Description: Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
Frequency Threshold: 5
Time Frame: Up to 2 years
Study: NCT02142803
Study Brief: TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced 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
Dose Level 1 - 3 mg MLN0128 Daily Stage 1 - Dose Level 1 participants: * 3 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks 3 None 0 3 3 3 View
Dose Level 2 - 4 mg MLN0128 Daily Stage 1 - Dose Level 2 participants: * 4 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks 2 None 0 3 3 3 View
Dose Level 3 - 5 mg MLN0128 Daily Inclusive of both Stage 1 - Dose Level 3 participants and Stage 2 participants treated at the MTD: * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks 36 None 19 43 43 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 4.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v 4.0 View
Death NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 4.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 4.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 4.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v 4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 4.0 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 4.0 View
Other, specify: Death due to progression of endometrial cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE v 4.0 View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
Other, specify - mood alteration SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v 4.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v 4.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 4.0 View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 4.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 4.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 4.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 4.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 4.0 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 4.0 View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 4.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 4.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 4.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 4.0 View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
Sinus pain SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v 4.0 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v 4.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v 4.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v 4.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v 4.0 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v 4.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 4.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 4.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 4.0 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 4.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 4.0 View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 4.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 4.0 View
Nail ridging SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 4.0 View
Palmar-plantar erythrodysesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 4.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 4.0 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 4.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 4.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 4.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 4.0 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 4.0 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v 4.0 View
Investigations - Other, specify: Globus sensation SYSTEMATIC_ASSESSMENT Investigations CTCAE v 4.0 View
Ear and labyrinth disorders - Other, specify: Ears bothering with mild fluid build-up SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v 4.0 View
Eye disorders - Other, specify: Decrease in vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v 4.0 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
Edema face SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v 4.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 4.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 4.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 4.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 4.0 View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations CTCAE v 4.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 4.0 View
Other, specify: LDH Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 4.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 4.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 4.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 4.0 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE v 4.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 4.0 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 4.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 4.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 4.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v 4.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Oral dysesthesia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View