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 @ 2:50 AM
Ignite Modification Date: 2025-12-26 @ 1:31 AM
NCT ID: NCT00130533
Description: None
Frequency Threshold: 0
Time Frame: 5 years
Study: NCT00130533
Study Brief: Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Xeloda (Capecitabine) 1000 mgrs/m2 twice a day, tablets, 8 cycles Capecitabine 71 None 23 436 416 436 View
Observation Observation. No intervention. 73 None 6 425 271 425 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thorax and left arm pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v. 3 View
Infection with unknown ANC pulmonary/upper respiratory - lung (pneumonia) SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v. 3 View
Diarrhea grade 2, Vomiting grade 2, Septic shock grade 5 SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v. 3 View
Showed lumbar column fracture(L4) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v. 3 View
Gastroenteritis and renal insuficience SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v. 3 View
Supraventricular arrhythmia NOS SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v. 3 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v. 3 View
Worsening of depressive syndrome SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v. 3 View
Thoracic pain grade 2, disnea G-1 SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v. 3 View
Infection with normal ANC ( Urinary) SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v. 3 View
Neutropenia G 3; Leucopenia G2 SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v. 3 View
CNS cerebrovascular ischemia SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v. 3 View
Hand-foot skin reaction SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v. 3 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v. 3 View
Right renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v. 3 View
Positive pregnant test performed SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions NCI CTCAE v. 3 View
Mucositis Oral cavity and Pharynx SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v. 3 View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v. 3 View
Infarction and cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v. 3 View
Thrombosis/thrombus/embolism: venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v. 3 View
Ischemia cardiac/Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v. 3 View
Axillary nodular resection SYSTEMATIC_ASSESSMENT Surgical and medical procedures NCI CTCAE v. 3 View
Coronary vasospam SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v. 3 View
Dehydration SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v. 3 View
Febrile neutropenia, Diarrhea, Hand foot skin reaction, Acute renal failure SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v. 3 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v. 3 View
Ulcer gastric SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v. 3 View
Hyperbilirrubinemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v. 3 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
LYMPHOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v. 3 View
LYMPHOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v. 3 View
LYMPHOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v. 3 View
LYMPHOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v. 3 View
BILIRUBIN SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v. 3 View
DIARRHEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v. 3 View
DIARRHEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v. 3 View
DIARRHEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v. 3 View
DIARRHEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v. 3 View
AST, SGOT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v. 3 View
AST, SGOT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v. 3 View
AST, SGOT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v. 3 View
RENAL FAILURE SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v. 3 View
RENAL FAILURE SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v. 3 View
URIC ACID, SERUM-HIGH SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v. 3 View
URIC ACID, SERUM-HIGH SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v. 3 View
IRREGULAR MENSES SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders NCI CTCAE v. 3 View
IRREGULAR MENSES SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders NCI CTCAE v. 3 View
IRREGULAR MENSES SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders NCI CTCAE v. 3 View
RASH: HAND-FOOT SKIN REACTION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v. 3 View
RASH: HAND-FOOT SKIN REACTION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v. 3 View
RASH: HAND-FOOT SKIN REACTION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v. 3 View
LEUKOCYTES (TOTAL WBC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v. 3 View
LEUKOCYTES (TOTAL WBC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v. 3 View
LEUKOCYTES (TOTAL WBC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v. 3 View
NEUTROPHILS/GRANULOCYTES SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v. 3 View
NEUTROPHILS/GRANULOCYTES SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v. 3 View
NEUTROPHILS/GRANULOCYTES SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v. 3 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v. 3 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v. 3 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v. 3 View
HEMOGLOBIN SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v. 3 View
HEMOGLOBIN SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v. 3 View
HEMOGLOBIN SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v. 3 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v. 3 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v. 3 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v. 3 View
ALT, SGPT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v. 3 View
ALT, SGPT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v. 3 View
ALT, SGPT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v. 3 View
NEUROPATHY: SENSORY SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v. 3 View
NEUROPATHY: SENSORY SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v. 3 View
NEUROPATHY: SENSORY SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v. 3 View