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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
NCT ID:
NCT02162667
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug
Study:
NCT02162667
Study Brief:
Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early 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 |
|---|---|---|---|---|---|---|---|---|
| CT-P6 | Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery) | None | None | 22 | 271 | 263 | 271 | View |
| Herceptin | Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\^2, epirubicin 75mg/m\^2, and cyclophosphamide 500mg/m\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional Herceptin 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery). | None | None | 36 | 278 | 264 | 278 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | None | Blood and lymphatic system disorders | None | View |
| Febrile neutropenia | None | Blood and lymphatic system disorders | None | View |
| Leukocytosis | None | Blood and lymphatic system disorders | None | View |
| Neutropenia | None | Blood and lymphatic system disorders | None | View |
| Acute myocardial infarction | None | Cardiac disorders | None | View |
| Adams-Stokes syndrome | None | Cardiac disorders | None | View |
| Angina pectoris | None | Cardiac disorders | None | View |
| Congestive cardiomyopathy | None | Cardiac disorders | None | View |
| Myocardial infarction | None | Cardiac disorders | None | View |
| Dacryostenosis acquired | None | Eye disorders | None | View |
| Abdominal pain | None | Gastrointestinal disorders | None | View |
| Gastritis | None | Gastrointestinal disorders | None | View |
| Haemorrhoidal haemorrhage | None | Gastrointestinal disorders | None | View |
| Pancreatitis acute | None | Gastrointestinal disorders | None | View |
| Stomatitis | None | Gastrointestinal disorders | None | View |
| Upper gastrointestinal haemorrhage | None | Gastrointestinal disorders | None | View |
| Implant site extravasation | None | General disorders | None | View |
| Incarcerated hernia | None | General disorders | None | View |
| Sudden death | None | General disorders | None | View |
| Cholecystitis acute | None | Hepatobiliary disorders | None | View |
| Drug hypersensitivity | None | Immune system disorders | None | View |
| Appendicitis | None | Infections and infestations | None | View |
| Bronchitis | None | Infections and infestations | None | View |
| Device related infection | None | Infections and infestations | None | View |
| Endocarditis | None | Infections and infestations | None | View |
| Pneumonia | None | Infections and infestations | None | View |
| Postoperative abscess | None | Infections and infestations | None | View |
| Septic embolus | None | Infections and infestations | None | View |
| Subcutaneous abscess | None | Infections and infestations | None | View |
| Complications of transplant surgery | None | Injury, poisoning and procedural complications | None | View |
| Humerus fracture | None | Injury, poisoning and procedural complications | None | View |
| Infusion related reaction | None | Injury, poisoning and procedural complications | None | View |
| Multiple fractures | None | Injury, poisoning and procedural complications | None | View |
| Overdose | None | Injury, poisoning and procedural complications | None | View |
| Pneumothorax traumatic | None | Injury, poisoning and procedural complications | None | View |
| Scar | None | Injury, poisoning and procedural complications | None | View |
| Seroma | None | Injury, poisoning and procedural complications | None | View |
| Thermal burn | None | Injury, poisoning and procedural complications | None | View |
| Heart rate irregular | None | Investigations | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Hypokalaemia | None | Metabolism and nutrition disorders | None | View |
| Breast cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Ovarian cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Ovarian germ cell teratoma benign | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Cerebral infarction | None | Nervous system disorders | None | View |
| Calculus urinary | None | Renal and urinary disorders | None | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary embolism | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Neurodermatitis | None | Skin and subcutaneous tissue disorders | None | View |
| Oocyte harvest | None | Surgical and medical procedures | None | View |
| Aortic dissection | None | Vascular disorders | None | View |
| Deep vein thrombosis | None | Vascular disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | None | Blood and lymphatic system disorders | None | View |
| Febrile neutropenia | None | Blood and lymphatic system disorders | None | View |
| Leukopenia | None | Blood and lymphatic system disorders | None | View |
| Neutropenia | None | Blood and lymphatic system disorders | None | View |
| Lacrimation increased | None | Eye disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Diarrhoea | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Stomatitis | None | Gastrointestinal disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Asthenia | None | General disorders | None | View |
| Fatigue | None | General disorders | None | View |
| Oedema peripheral | None | General disorders | None | View |
| Pyrexia | None | General disorders | None | View |
| Upper respiratory tract infection | None | Infections and infestations | None | View |
| Infusion related reaction | None | Injury, poisoning and procedural complications | None | View |
| Radiation skin injury | None | Injury, poisoning and procedural complications | None | View |
| Alanine aminotransferase increased | None | Investigations | None | View |
| Aspartate aminotransferase increased | None | Investigations | None | View |
| Ejection fraction decreased | None | Investigations | None | View |
| Neutrophil count decreased | None | Investigations | None | View |
| Decreased appetite | None | Metabolism and nutrition disorders | None | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | None | View |
| Bone pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | None | View |
| Dizziness | None | Nervous system disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Peripheral sensory neuropathy | None | Nervous system disorders | None | View |
| Insomnia | None | Psychiatric disorders | None | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Alopecia | None | Skin and subcutaneous tissue disorders | None | View |
| Rash | None | Skin and subcutaneous tissue disorders | None | View |
| Hypertension | None | Vascular disorders | None | View |