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 @ 6:45 PM
Ignite Modification Date:
2025-12-25 @ 4:16 PM
NCT ID:
NCT00618657
Description:
Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.
Frequency Threshold:
0
Time Frame:
Up to 5 years
Study:
NCT00618657
Study Brief:
Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting
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 I (HER-2 Positive) | Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes, carboplatin IV over 60 minutes, and trastuzumab IV over 90 minutes , then weekly over 30-60 minutes. Treatment repeats every week for 12 weeks in the absence of disease progression or unacceptable toxicity. In both arms, beginning 21-40 days later, patients undergo surgery. Carboplatin: Given IV paclitaxel albumin-stabilized nanoparticle formulation: Given IV trastuzumab: Given IV magnetic resonance imaging: Optional correlative studies therapeutic conventional surgery: Post-chemotherapy surgery for patients with a response or stable disease must take place no sooner than 21 days after last dose of Herceptin; and 40 days after last dose of bevacizumab to allow for normalization of blood counts | 5 | None | 2 | 42 | 19 | 42 | View |
| Arm II (HER-2 Negative) | Patients receive paclitaxel albumin-stabilized nanoparticle formulation and carboplatin as in Arm I. Patients also receive bevacizumab IV over 90 or 60 or 30 minutes once every two weeks for 5 doses in the absence of disease progression or unacceptable toxicity. In both arms, beginning 21-40 days later, patients undergo surgery. Carboplatin: Given IV paclitaxel albumin-stabilized nanoparticle formulation: Given IV bevacizumab: Given IV magnetic resonance imaging: Optional correlative studies therapeutic conventional surgery: Post-chemotherapy surgery for patients with a response or stable disease must take place no sooner than 21 days after last dose of Herceptin; and 40 days after last dose of bevacizumab to allow for normalization of blood counts | 11 | None | 1 | 85 | 50 | 85 | View |
Serious Events(If Any):
Serious Events
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Peripheral Neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Upper Respiratory Infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Carboplatin Allergic Reaction | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Vaginal Infection | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Biliary Tract Infection | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Maculopapular Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hot Flashes | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Tooth Infection | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Nonhealing Would | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hand Foot Syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Amenorrhea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Bronchial Infection | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |