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 @ 1:30 PM
Ignite Modification Date:
2025-12-25 @ 12:32 PM
NCT ID:
NCT00039195
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00039195
Study Brief:
Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplant in Treating Patients With 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 |
|---|---|---|---|---|---|---|---|---|
| Induction R-CHOPac Therapy | Induction R-CHOPac Therapy for patients with B-Cell Lymphoma | None | None | 20 | 98 | 98 | 98 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain/cramping | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-2.0 | View |
| Arachnoiditis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTC-2.0 | View |
| Constitutional symptoms, other | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Delusions | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| GI, other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-2.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Hemoglobin (Hgb) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Hemorrhage, other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTC-2.0 | View |
| Ileus (or neuroconstipation) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-2.0 | View |
| Infection without neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTC-2.0 | View |
| Radiation mucositis | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-2.0 | View |
| Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Neutrophils | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Pain - Stomach | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-2.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Pulmonary, other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | View |
| Supravent arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTC-2.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-2.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Bilirubin | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hemoglobin (Hgb) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Infection without neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTC-2.0 | View |
| Leukocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Neutrophils | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Prothrombin time (PT) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Partial thromboplastin time (PTT) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| SGOT (AST) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| SGPT (ALT) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |