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 @ 2:10 AM
Ignite Modification Date:
2025-12-26 @ 12:38 AM
NCT ID:
NCT00258960
Description:
49 patients included but 1 is not considered due to not receive any treatment and died before start
Frequency Threshold:
0
Time Frame:
Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
Study:
NCT00258960
Study Brief:
Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic 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 |
|---|---|---|---|---|---|---|---|---|
| Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab | Liposomal Doxorubicin 50 mg/m2 every 4 weeks for six cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for six cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg) | 2 | None | 16 | 48 | 48 | 48 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cerebrovascular ischemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTC-AE v. 3 | View |
| Febrile neutropenia grade 3 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | View |
| Hemorrhage CNS grade 5 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTC-AE v. 3 | View |
| Infection with normal ANC (skin celluties grade 3) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTC-AE v. 3 | View |
| Acute respiratory insufficiency | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTC-AE v. 3 | View |
| Catheter - related infection grade 3 | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTC-AE v. 3 | View |
| Holocraneal cephalea | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC-AE v. 3 | View |
| Neutropenia grade 3 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | View |
| Hemorrhage subarachnoid | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI-CTC-AE v. 3 | View |
| Hypersensibility reaction grade 3 | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC-AE v. 3 | View |
| Palmoplantar erythrodysesthesia grade 3, stomatitis grade 3 | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC-AE v. 3 | View |
| Progression disease | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI-CTC-AE v. 3 | View |
| Neutropenia grade 4, fever grade 1, oral mucositis grade 3 | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC-AE v. 3 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Leukocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | View |
| Neutrophils / Granulocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC-AE v. 3 | View |
| Mucositis / Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC-AE v. 3 | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTC-AE v. 3 | View |
| Pneumonitis/Pulmonary infiltrates | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI-CTC-AE v. 3 | View |
| Leukocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | View |
| Leukocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | View |
| Rash: Hand-foot skin reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTC-AE v. 3 | View |
| Mucositis / Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC-AE v. 3 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | View |
| Neutrophils / Granulocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | View |
| Neutrophils / Granulocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | View |
| Left Ventricular systolic dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTC-AE v. 3 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC-AE v. 3 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC-AE v. 3 | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTC-AE v. 3 | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTC-AE v. 3 | View |
| Rash: Hand-foot skin reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTC-AE v. 3 | View |
| Rash: Hand-foot skin reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTC-AE v. 3 | View |
| Heartburn/dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC-AE v. 3 | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | View |
| Leukocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | View |
| Left Ventricular diastolic dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTC-AE v. 3 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC-AE v. 3 | View |
| Hair loss/alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTC-AE v. 3 | View |
| Hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTC-AE v. 3 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC-AE v. 3 | View |
| Mucositis / Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC-AE v. 3 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC-AE v. 3 | View |
| Infection with normal ANC or G1 or 2 neutrophils | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTC-AE v. 3 | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI-CTC-AE v. 3 | View |
| ALT, SGPT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI-CTC-AE v. 3 | View |
| AST, SGOT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI-CTC-AE v. 3 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTC-AE v. 3 | View |