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 @ 2:44 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT02633059
Description: None
Frequency Threshold: 0
Time Frame: Up to 3 years
Study: NCT02633059
Study Brief: Idasanutlin, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase 1: Dose Level 0 Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg 0 None 0 4 4 4 View
Phase 1: Dose Level 1 Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg 0 None 3 7 7 7 View
Phase 1: Dose Level 2 Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg 0 None 0 4 4 4 View
Phase 2: Dose Level 1 Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg 2 None 6 17 17 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15 View
Neoplasms benign, mal, uncpec - Oth spec SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15 View
Thrombotic thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15 View
Cardiac disorders - Other, specify SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 15 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 15 View
Bronchial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15 View
Rhinitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15 View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15 View
Resp, thoracic, mediastinal - Oth spec SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15 View