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 @ 1:04 PM
Ignite Modification Date:
2025-12-25 @ 12:20 PM
NCT ID:
NCT00578461
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00578461
Study Brief:
T-Regulatory Cell Kinetics, Stem Cell Transplantation, REGKINE
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Stem Cell Transplant | All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion. Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation. Ara C: 3000 mg/m\^2 - pts will receive via IV every 12 hours for 6 doses starting at 20:00 hours on day -8.Mesna: 45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Cyclophosphamide: 45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours.TBI-Total Body Irradiation: Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4 to day -1. Stem cell Infusion is on day 0. | None | None | 15 | 26 | 16 | 26 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Coagulation - Other: Severe coagulopathy | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Rash/desquamation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Liver dysfunction/failure (clinical) | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection with Grade 3 or 4 neutrophils - Catheter-related | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection with Grade 3 or 4 neutrophils - Vein | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection - Other: only clinical signs of infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Blood | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Nose | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| AST, SGOT | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Pain - Abdomen NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain - Head/headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Portal vein flow | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Allergic reaction/hypersensitivity (including drug fever) | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Pericardial effusion (non-malignant) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| ALT, SGPT | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| PTT | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Mucositis/stomatitis (clinical exam) - Oral cavity | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| AST, SGOT | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Bilirubin (hyperbilirubinemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Calcium, serum-low (hypocalcemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| GGT | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Glucose, serum-high (hyperglycemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Sodium, serum-low (hyponatremia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |