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 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
NCT ID:
NCT00129935
Description:
None
Frequency Threshold:
0
Time Frame:
Through study treatment up to 30 days after last study dose, up to 7 months
Study:
NCT00129935
Study Brief:
EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable 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 |
|---|---|---|---|---|---|---|---|---|
| Arm A: EC-T | Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles. Docetaxel Epirubicin Cyclophosphamide | 70 | None | 111 | 669 | 665 | 669 | View |
| Arm B: ET-X | Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles. Docetaxel Capecitabine Epirubicin | 83 | None | 138 | 715 | 699 | 715 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Leukocytes | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v. 2.0 | View |
| Bronchospasm | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v. 2.0 | View |
| Mucositis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Abdominal pain and hematuria | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v. 2.0 | View |
| Hand foot skin reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTCAE v. 2.0 | View |
| Breast implant repeled | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | NCI-CTCAE v. 2.0 | View |
| Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE v. 2.0 | View |
| Proctitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Thrombosis/embolism | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE v. 2.0 | View |
| Mood alteration-anxiety agitation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTCAE v. 2.0 | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v. 2.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Systemic lupus erythematosus | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | NCI-CTCAE v. 2.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v. 2.0 | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTCAE v. 2.0 | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTCAE v. 2.0 | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v. 2.0 | View |
| Infection with grade 3 or 4 neutropenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTCAE v. 2.0 | View |
| Infection without neutropenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTCAE v. 2.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE v. 2.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE v. 2.0 | View |
| Fistula anal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Stomach flu | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Mucositis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Mucositis / Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Pancreatic adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Thrombosis/embolism | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE v. 2.0 | View |
| Hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v. 2.0 | View |
| Proctitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Allergic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | NCI-CTCAE v. 2.0 | View |
| Bone Fracture | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v. 2.0 | View |
| Cardiac ischemia / infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE v. 2.0 | View |
| Cardiac ischemia / infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE v. 2.0 | View |
| Catheter-related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTCAE v. 2.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| CNS cerebrovascular ischemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v. 2.0 | View |
| CNS cerebrovascular ischemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v. 2.0 | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTCAE v. 2.0 | View |
| Creatinine | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE v. 2.0 | View |
| Pneumonitis/Pulmonary infiltrates | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v. 2.0 | View |
| Thoracic pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v. 2.0 | View |
| Biliary colic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Bleeding | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI-CTCAE v. 2.0 | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v. 2.0 | View |
| Epidermis necrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTCAE v. 2.0 | View |
| Arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE v. 2.0 | View |
| Progression disease, carcinomatosis meninges | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI-CTCAE v. 2.0 | View |
| Phenytoin poisoning interaction with capecitabine | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | NCI-CTCAE v. 2.0 | View |
| Ureteral obstruction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI-CTCAE v. 2.0 | View |
| Neuropathy-sensory | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTCAE v. 2.0 | View |
| Conduction abnormality/ Atrioventricular heart block | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE v. 2.0 | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTCAE v. 2.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| NEUTROPHILS/GRANULOCYTES | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v. 2.0 | View |
| SGPT (ALT) | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI-CTCAE v. 2.0 | View |
| LYMPHOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v. 2.0 | View |
| NEUTROPHILS/GRANULOCYTES | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v. 2.0 | View |
| NEUTROPHILS/GRANULOCYTES | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v. 2.0 | View |
| LEUKOCYTES (TOTAL WBC) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v. 2.0 | View |
| LEUKOCYTES (TOTAL WBC) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v. 2.0 | View |
| LEUKOCYTES (TOTAL WBC) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v. 2.0 | View |
| IRREGULAR MENSES | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI-CTCAE v. 2.0 | View |
| HAND-FOOT SKIN REACTION | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTCAE v. 2.0 | View |
| HAND-FOOT SKIN REACTION | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTCAE v. 2.0 | View |
| ALOPECIA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTCAE v. 2.0 | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v. 2.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| STOMATITIS/PHARYNGITIS (ORAL/PHARYNGEAL MUCOSITIS) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| DIARRHEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE v. 2.0 | View |
| HEMOGLOBIN | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE v. 2.0 | View |
| NAIL CHANGES | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTCAE v. 2.0 | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| ARTHRALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI-CTCAE v. 2.0 | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE v. 2.0 | View |
| INFECTION WITHOUT NEUTROPENIA | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | NCI-CTCAE v. 2.0 | View |
| MYALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI-CTCAE v. 2.0 | View |