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 @ 11:42 PM
Ignite Modification Date: 2025-12-25 @ 9:34 PM
NCT ID: NCT02254551
Description: All patients who received at least one dose of LDE225 plus bortezomib.
Frequency Threshold: 0
Time Frame: Treatment-emergent adverse events were collected on Days 1 and 8 of every 21-day cycle for up to 48 weeks (plus 30 days for end of treatment visit).
Study: NCT02254551
Study Brief: Safety/Efficacy Study of LDE225 (Sonidegib) Plus Bortezomib in Patients With Relapsed or Relapsed/Refractory 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
Cohort 2: LDE225 600mg/m^2 Cohort 2 will receive LDE225 orally on a daily basis, at 600 mg every 21 days. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle. None None 0 0 0 0 View
Cohort 1: LDE225 400mg/m^2 Cohort 1 will receive LDE225 orally on a daily basis, at 400mg/m\^2 every 21 days. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle. None None 2 7 6 7 View
Cohort 3: LDE225 800mg/m^2 Cohort 3 will receive LDE225 orally on a daily basis, at 800mg/m\^2 every 21 days. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle. None None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Viral Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.03 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.03 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.03 View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE 4.03 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE 4.03 View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE 4.03 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE 4.03 View
Decreased creatinine clearance NON_SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE 4.03 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE 4.03 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE 4.03 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE 4.03 View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE 4.03 View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE 4.03 View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE 4.03 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE 4.03 View
Confusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE 4.03 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE 4.03 View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE 4.03 View
Edema Limbs NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE 4.03 View
Fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE 4.03 View
Muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE 4.03 View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE 4.03 View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE 4.03 View
Hyperuricemia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE 4.03 View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE 4.03 View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI CTCAE 4.03 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE 4.03 View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE 4.03 View
Cyst NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE 4.03 View
Restlessness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE 4.03 View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE 4.03 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE 4.03 View
Increased creatinine NON_SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE 4.03 View