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 @ 12:20 PM
Ignite Modification Date:
2025-12-25 @ 12:03 PM
NCT ID:
NCT00278161
Description:
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
Frequency Threshold:
5
Time Frame:
Up to 1 year
Study:
NCT00278161
Study Brief:
Rituximab, Cyclophosphamide, and Pegfilgrastim in Treating Patients With Leukemia or Non-Hodgkin's Lymphoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| R-HiCy | Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support. Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide. Rituximab: 375 mg/m\^2/day on Days 1, 4, 8, 11, 45, and 52. Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18. | 11 | None | 15 | 81 | 64 | 81 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Infection (unspecified) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Lipase elevated | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Pain - wrist | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Secondary malignancy - acute myeloid leukemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Atrial fibrillation with rapid ventricular response | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ALT high | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| AST high | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Pain - abdomen | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - back | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - central catheter site | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - hip | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - mouth | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rigors | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Diaphoresis | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Bloating | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Edema | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Hemorrhoids | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Lightheadedness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Pain - bone | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |