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 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
NCT ID:
NCT01589302
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01589302
Study Brief:
PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment (Ibrutinib) | Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy. ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progres | None | None | 152 | 152 | 152 | 152 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE version 4.0 | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE version 4.0 | View |
| Injury, Poisoning and Procedural Complications - Other | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE version 4.0 | View |
| Intestinal Stoma Obstruction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE version 4.0 | View |
| Postoperative Hemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE version 4.0 | View |
| Spinal Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE version 4.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Metabolism and Nutrition Disorders - Other | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | View |
| Generalized Muscle Weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | View |
| Muscle Weakness Left Sided | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | View |
| Musculoskeletal and Connective Tissue Disorder - Other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | View |
| Leukoencephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Memory Impairement | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Nervous System Disorders - Other | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Transient Ischemic Attacks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Psychiatric Disorders-Other | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE version 4.0 | View |
| Renal and Urinary Disorders - Other | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE version 4.0 | View |
| Urinary Tract Obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE version 4.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Respiratory, Thoracic, and Mediastinal Disorders - Other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Rash Maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Surgical and Medical Procedures - Other | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE version 4.0 | View |
| Hematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE version 4.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE version 4.0 | View |
| Superior Vena Cava Syndrom | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE version 4.0 | View |
| Thromboembolic Events | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE version 4.0 | View |
| Vascular Disorders- Other | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE version 4.0 | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Hemolytic Uremic Syndrome | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Lymph Node Pain | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Blurred Vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE version 4.0 | View |
| Colonic Perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Esophageal Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Gastric Hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Gastrointestinal Disorders-other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Jejunal Hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Small Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Edema Limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| General Disorders and Administration Site Conditions - Other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Bronchial Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Catheter Related Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Enterocolitis Infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Infections and Infestations-other | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Lung Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Otitis Media | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Cardiac Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Cardiac Disorders-other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Ventricular Arrythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Non-Cardiac Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Sudden Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE version 4.0 | View |
| Immune System Disorders - Other | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE version 4.0 | View |
| Bone Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Soft Tissue Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Upper Respiratory Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Intracranial Hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Reproductive System and Breast Disorders - Other | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE version 4.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Flu Like Symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| General Disorders | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Non-Cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Bronchial Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Eye Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Infections and Infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Lung Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Nail Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Upper Respiratory Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Bruising | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE version 4.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE version 4.0 | View |
| Injury, Poisoning and procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE version 4.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Lymphocyte count increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| White Blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hyperuricemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | View |
| Musculoskeletal and Connective tissue disorder-other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | View |
| Pain Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | View |
| Neoplasms benign, malignant and unspecified-other | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE version 4.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Nervous System Disorders-other | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Lymph node pain | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Sinus Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Sinus Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Watering eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE version 4.0 | View |
| Bloating | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Gastrointestional Disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Oral Hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Oral Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Stomach Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Ear and Labyrinth disorders | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE version 4.0 | View |
| Hearing impaired | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE version 4.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE version 4.0 | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE version 4.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE version 4.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE version 4.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE version 4.0 | View |
| Eye Disorders | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE version 4.0 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Edema Limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |