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 @ 3:03 PM
Ignite Modification Date: 2025-12-25 @ 1:25 PM
NCT ID: NCT02581059
Description: None
Frequency Threshold: 0
Time Frame: Begin C1D1 and every chemotherapy cycles (4 weeks) thereafter, for up to 18 months or until unacceptable toxicity.
Study: NCT02581059
Study Brief: Efficacy of Ginseng for Patients on Regorafenib
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Regorafenib Only Regorafenib will be administered 160 mg once daily for the first 21 days of each 28-day cycle for 2 cycles. Regorafenib: All subjects will receive regorafenib 160 mg orally once daily for the first 21 days of each 28-day cycle for 2 cycles. 2 None 0 4 4 4 View
Regorafenib + Ginseng Regorafenib will be administered 160 mg once daily for the first 21 days of each 28-day cycle. Subjects will receive 1,000 mg ginseng orally twice daily every day for 4 weeks (2 cycles). Regorafenib: All subjects will receive regorafenib 160 mg orally once daily for the first 21 days of each 28-day cycle for 2 cycles. Ginseng: Subjects randomized to ginseng will receive 1,000 mg orally twice every day of each 28-day cycle for 2 cycles. 4 None 2 6 5 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ACUTE KIDNEY INJURY NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4 View
ALANINE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
HEPATOBILIARY DISORDERS NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAEv4 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
ALKALINE PHOSPHATASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
ANOREXIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
BLOOD BILIRUBIN INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
BONE PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
CHILLS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
DYSPNEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
EDEMA LIMBS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
GENERALIZED MUSCLE WEAKNESS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
HEMATURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4 View
HOARSENESS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
HYPOALBUMINEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
HYPOCALCEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
HYPOGLYCEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
HYPOKALEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
HYPONATREMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
LYMPHOCYTE COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
MALAISE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
PAIN IN EXTREMITY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
PERICARDIAL EFFUSION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv4 View
PERIPHERAL SENSORY NEUROPATHY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
PLATELET COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
RASH PUSTULAR NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4 View
SINUS TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv4 View
SKIN ULCERATION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4 View
UPPER RESPIRATORY INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
WEIGHT LOSS NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
ALANINE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
ANEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv4 View
ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv4 View
ASPARTATE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
BLURRED VISION NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv4 View
BREAST PAIN NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAEv4 View
CHRONIC KIDNEY DISEASE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4 View
CONFUSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv4 View
CREATININE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
DEHYDRATION NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv4 View
DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
EPISTAXIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
HEMORRHOIDS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4 View
HYPOPHOSPHATEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
HYPOTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4 View
MUCOSITIS ORAL NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
ORAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4 View
PELVIC PAIN NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAEv4 View
RECTAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
SORE THROAT NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
WHITE BLOOD CELL DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
DRY MOUTH NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
DYSPHAGIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View