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 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
NCT ID:
NCT00559104
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00559104
Study Brief:
Combination Chemotherapy With or Without Total-Body Irradiation Followed By Stem Cell Transplant in Treating Patients With Non-Hodgkin 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 |
|---|---|---|---|---|---|---|---|---|
| Irradiation in Conditioning | total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor cyclophosphamide etoposide autologous hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation G-CSF | None | None | 0 | 55 | 39 | 55 | View |
| Carmustine in Conditioning | Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor carmustine cyclophosphamide etoposide autologous hematopoietic stem cell transplantation peripheral blood stem cell transplantation G-CSF | None | None | 0 | 5 | 1 | 5 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dermatologic (Skin) (COH) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | COH | View |
| Hepatic | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | COH | View |
| Mucositis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | COH | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Hemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Packed red blood cell transfusion | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Platelet transfusion | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra9.0 | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra9.0 | View |
| External ear inflammation | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | meddra9.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Esophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Gastrointestinal disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Mucositis oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra9.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Oedema NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra9.0 | View |
| Infection, Viral (COH) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | COH | View |
| Radiation oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra9.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Hyperbilirubinemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Laboratory test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra9.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hyperkalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hypocalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hypomagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra9.0 | View |
| Neurological disorder NOS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra9.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra9.0 | View |
| Blood urine present | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra9.0 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra9.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Rash desquamating | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra9.0 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra9.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra9.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra9.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra9.0 | View |
| Catheter related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Infection NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra9.0 | View |
| Infection, Bacterial (COH) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | COH | View |
| Infection, Fungal (COH) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | COH | View |
| Muscle weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra9.0 | View |