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 @ 2:31 PM
Ignite Modification Date:
2025-12-25 @ 1:04 PM
NCT ID:
NCT01401959
Description:
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Frequency Threshold:
5
Time Frame:
Day 1 and Day 8 of every treatment cycle and 30 days after discontinuation or completion of treatment for up to 22.2 weeks
Study:
NCT01401959
Study Brief:
Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
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 A: Triple-negative Breast Cancer | Patients with Triple-Negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m\^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. | 6 | None | 8 | 53 | 52 | 52 | View |
| Cohort B: ER/PR Positive/HER2-negative Breast Cancer | Patients with ER positive and/or PR positive, HER-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m\^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. | 4 | None | 1 | 42 | 42 | 42 | View |
| Cohort C: HER2 Positive Breast Cancer | Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m\^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days. | 1 | None | 3 | 31 | 31 | 31 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diabetes mellitus inadequate control | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (unspecified) | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (unspecified) | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (unspecified) | View |
| Mastitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (unspecified) | View |
| Metastasis | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (unspecified) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (unspecified) | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (unspecified) | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (unspecified) | View |
| Tracheobronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (unspecified) | View |
| Ventricular arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (unspecified) | View |
| Cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (unspecified) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (unspecified) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (unspecified) | View |
| Neutrophil Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (unspecified) | View |
| Peripheral Sensory Neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (unspecified) | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (unspecified) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (unspecified) | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (unspecified) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (unspecified) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (unspecified) | View |
| Edema | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (unspecified) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (unspecified) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (unspecified) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (unspecified) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (unspecified) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (unspecified) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (unspecified) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (unspecified) | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (unspecified) | View |
| Lymphocyte Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (unspecified) | View |
| Bone Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | View |
| Mucositis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (unspecified) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (unspecified) | View |
| Lymphedema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (unspecified) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (unspecified) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (unspecified) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (unspecified) | View |
| Alanine Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (unspecified) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (unspecified) | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (unspecified) | View |
| Pain In Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | View |
| Hot Flashes | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (unspecified) | View |
| Gastroesophageal Reflux Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (unspecified) | View |
| Hypomagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (unspecified) | View |
| Nasal Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (unspecified) | View |
| Allergic Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (unspecified) | View |
| Generalized Muscle Weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (unspecified) | View |
| Upper Respiratory Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (unspecified) | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (unspecified) | View |
| Sore Throat | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (unspecified) | View |
| Platelet Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (unspecified) | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | View |
| Blurred Vision | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (unspecified) | View |
| Skin And Subcutaneous Tissue Disorders - Other, Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (unspecified) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (unspecified) | View |
| Non-Cardiac Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (unspecified) | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (unspecified) | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (unspecified) | View |
| Cheilitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (unspecified) | View |
| Cognitive Disturbance | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (unspecified) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (unspecified) | View |
| Watering Eyes | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (unspecified) | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (unspecified) | View |
| Breast Pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (unspecified) | View |
| Respiratory, Thoracic And Mediastinal Disorders - Other, Runny Nose | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (unspecified) | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (unspecified) | View |
| Nail Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (unspecified) | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (unspecified) | View |
| Paresthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (unspecified) | View |
| Infections And Infestations - Other, Herpes Zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (unspecified) | View |
| Aspartate Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (unspecified) | View |
| Dry Mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (unspecified) | View |