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: 2025-12-25 @ 12:30 AM
Ignite Modification Date: 2025-12-25 @ 10:37 PM
NCT ID: NCT01198067
Description: Toxicity graded using NCI Common Terminology Criteria for Adverse Events, v3.0 Nonheme Pomalidomide dose limiting toxicity gr 3 \~\>except gr3\> fatigue, nausea/vomiting, or nonheme abnormal labs resolving to gr1 / baseline 14 days 1st dose. Hematologic toxicity defined as gr4 neutropenia lasting \> 14 days, febrile neutropenia, thrombocytopenia (plt #\< 25k) \> 14 days. All AEs recorded from study entry/first dose-30 days after last dose and/or AE resolution:1/1/2011 to 6/7/2022.
Frequency Threshold: 0
Time Frame: All Adverse Events were collected through Study Completion (Avg. 1 Year)
Study: NCT01198067
Study Brief: Pomalidomide in Treating Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 2 2mg Pomolidomide per day per Cycle (Cycle = 28 days) 0 None 3 3 3 3 View
Cohort 3 1mg Pomolidomide per day per Cycle (Cycle = 28 days) 0 None 1 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 3.0 View
Infection (Knee) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3.0 View
Caudia Equina Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 3.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 3.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3.0 View
Dry eye syndrome SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Laryngeal inflamation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Laryngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Investigations CTCAE 3.0 View
Lip pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Neurology (Other) - Drowsiness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 3.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3.0 View
Lymph node pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 3.0 View
Lymphatics (Other) - Left axillary nodule SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 3.0 View
Metabolic/Laboratory (Other) - Anemia SYSTEMATIC_ASSESSMENT Investigations CTCAE 3.0 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3.0 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Allergy/Immunology (Other) - Allergic Sinusitis SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Allergy/Immunology (Other) - Lidocaine SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Allergy/Immunology (Other) - Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Bruising SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 3.0 View
Bruising - Injury / Laceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3.0 View
Conjunctival disorder SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Constitutional Symptoms (Other) - Pelvic Cystic Mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3.0 View
Depression SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 3.0 View
Dermatology/Skin (Other) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3.0 View
Dermatology/Skin (Other) - Injury / Laceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3.0 View
Dermatology/Skin (Other) - non-malignant growths SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3.0 View
Dermatology/Skin (Other) - Rash NOS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3.0 View
Dermatology/Skin (Other) - Rash: Erithematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3.0 View
Dermatology/Skin (Other) - SCC SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3.0 View
Dermatology/Skin (Other)- non-malignant skin cancer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 3.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Edema limbs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3.0 View
Eye pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Eyelid function disorder - Eyelid edema SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Gastrointestinal (Other) - Colorectal polyps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Gastrointestinal (Other) - GERD SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Gingival infection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Headache SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3.0 View
Hypertension SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Infection - COVID + SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3.0 View
Infection - Human Rhinovirus SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3.0 View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 3.0 View
Joint disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3.0 View
Joint infection SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3.0 View
Metabolic/Laboratory (Other) - Hypercapnia SYSTEMATIC_ASSESSMENT Investigations CTCAE 3.0 View
Metabolic/Laboratory (Other) - Hyperglycemia SYSTEMATIC_ASSESSMENT Investigations CTCAE 3.0 View
Metabolic/Laboratory (Other) - Hypomagnesemia SYSTEMATIC_ASSESSMENT Investigations CTCAE 3.0 View
Metabolic/Laboratory (Other) - Hypophosphatemia SYSTEMATIC_ASSESSMENT Investigations CTCAE 3.0 View
Metabolic/Laboratory (Other) - Lymphocyte Abs increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3.0 View
Metabolic/Laboratory (Other) - Vitamin D defficiency SYSTEMATIC_ASSESSMENT Investigations CTCAE 3.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Musculoskeletal (Other) - Cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3.0 View
Musculoskeletal (Other) - Injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3.0 View
Musculoskeletal (Other) - muscle aches SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3.0 View
Musculoskeletal (Other) - Pulled muscle SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3.0 View
Nail infection SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3.0 View
Night Sweats SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Ocular/Visual (Other) - Blurred Vision SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Ocular/Visual (Other) - Dysfunctional Tear Syndrome SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Ocular/Visual (Other) - Edema Lids SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Ocular/Visual (Other) - Increased Eye Pressure SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Ocular/Visual (Other) - Irritated Eyes SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Ocular/Visual (Other) - Ocular Conjunctive Hemmorhage SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Ocular/Visual (Other) - Watery eyes SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Otitis media SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Pain (Other) SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Pain (Other) - L Thigh SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3.0 View
Pulmonary (Other) - Chest Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3.0 View
Rhinitis infective SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Serum magnesium decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3.0 View
Serum phosphate decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Skin and subcutaneous tissue disorders - Injury / Laceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3.0 View
Sweating SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Treatment related secondary malignancy (Specify, Other) - SCC SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3.0 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3.0 View
Vascular (Other) SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 3.0 View
Vision blurred SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Watering eyes SYSTEMATIC_ASSESSMENT General disorders CTCAE 3.0 View
Wound infection - Injury / Laceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3.0 View
Wound infection - Injury / Laceration / Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3.0 View