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 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 2:00 AM
NCT ID: NCT02261805
Description: Adverse events were reported as pooling all subjects together and were not broken out by group.
Frequency Threshold: 0
Time Frame: None
Study: NCT02261805
Study Brief: A Phase I/II Study of Ganetespib in Combination With Doxorubicin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ganetespib and Doxorubicin Ganetespib 100 or 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle 0 None 1 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Immune system disorders None View
Pain SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT General disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Immune system disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
AST elevation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Gastrointestinal anastomotic leak SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Immune system disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Epigastric pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Elavated LDH SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Mucositis oral SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Back stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View