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 @ 11:53 AM
Ignite Modification Date: 2025-12-25 @ 11:53 AM
NCT ID: NCT01013961
Description: None
Frequency Threshold: 5
Time Frame: Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Study: NCT01013961
Study Brief: Rituximab and Alemtuzumab in Treating Older Patients With Progressive Chronic Lymphocytic 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
Arm A (Standard Dose) Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m\^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles. Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week. None None 16 16 16 16 View
Arm B (Low Dose) Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m\^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles. Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week. None None 15 15 15 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Serum sickness SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE 4.0 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Nervous system disorders - Other SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Investigations - Other, specify SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE 4.0 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Infections and infestations - Other SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View