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 @ 3:50 PM
Ignite Modification Date: 2025-12-25 @ 1:57 PM
NCT ID: NCT01381692
Description: None
Frequency Threshold: 5
Time Frame: Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Study: NCT01381692
Study Brief: Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma
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 (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) Patients receive temsirolimus IV at dose level 1 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. 1 None 7 7 7 7 View
Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone) Patients receive temsirolimus IV at dose level 2 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. 0 None 1 2 2 2 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
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Neutrophil count decreased 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
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Nail infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 4.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Creatinine increased 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
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Investigations - Other, specify SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue 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
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Sinus disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View