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 @ 1:03 PM
Ignite Modification Date: 2025-12-25 @ 12:20 PM
NCT ID: NCT00881361
Description: Each CTCAE term is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who started treatment \& were evaluated for AEs. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and are in the SAE table.
Frequency Threshold: 0
Time Frame: 1-2 weeks post surgery
Study: NCT00881361
Study Brief: Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
cN1 Cohort Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. 1 None 6 676 192 676 View
cN2 Cohort Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. 0 None 0 39 9 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Upper extremity dysfunction SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Lymphatic disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Ear disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12 View
Eye disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Peripheral nerve infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Postoperative hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Small intestinal anastomotic leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum glucose decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum magnesium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Joint disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Joint range of motion decreased cervical spine SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Muscle weakness upper limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Musculoskeletal disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Upper extremity dysfunction SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Neurological disorder NOS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Taste alteration SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Urine discoloration SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12 View
Ovulation pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12 View
Vaginal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Chest wall necrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View