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:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
NCT ID:
NCT00928018
Description:
All AEs grades 3-5 and SAEs whether reported by participant, discovered during questioning, directly observed, or detected by physical examination, laboratory test, etc, will be recorded in participant's medical record and appropriate study-specific forms
Only events reported in \>1 patient on at least one of the arms are listed in Other AE table
Frequency Threshold:
0
Time Frame:
Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. The study defined follow up period is 2 years.
Study:
NCT00928018
Study Brief:
Tacrolimus/Sirolimus/Methotrexate vs Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for 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 |
|---|---|---|---|---|---|---|---|---|
| Sirolimus-Containing Regimen | The Sirolimus containing arm will consist of the following drugs: Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3. Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2. Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6. Sirolimus: Taken orally for at least 12 months Methotrexate: Given intravenously on the first, third and sixth day after transplant Tacrolimus: Taken orally or given intravenously for at least 6 months | None | None | 15 | 66 | 41 | 66 | View |
| Sirolimus-Free Regimen | There are two choices for the Sirolimus free arm: Control Arm 1: tacrolimus + methotrexate Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11. Control Arm 2: cyclosporine + MMF Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Methotrexate: Given intravenously on the first, third and sixth day after transplant Tacrolimus: Taken orally or given intravenously for at least 6 months Cyclosporine: Taken orally or given intravenously for at least 6 months MMF: Taken orally for about 2 months | None | None | 15 | 73 | 54 | 73 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Other: Relapse/Progressive disease | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE Version 3.0 | View |
| Treatment Related Secondary Malignancy | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE Version 3.0 | View |
| Hemolysis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE Version 3.0 | View |
| Thrombotic Microangiopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE Version 3.0 | View |
| Pericardial Effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE Version 3.0 | View |
| Supraventricular and Nodal Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE Version 3.0 | View |
| Gastrointestinal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE Version 3.0 | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE Version 3.0 | View |
| Liver failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE Version 3.0 | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE Version 3.0 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE Version 3.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE Version 3.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE Version 3.0 | View |
| Acute Kidney Injury/Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE Version 3.0 | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 3.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 3.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 3.0 | View |
| Other--Respiratory failure/lung injury | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 3.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE Version 3.0 | View |
| Pulmonary hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 3.0 | View |
| Other--Stroke | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE Version 3.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE Version 3.0 | View |
| GVHD | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE Version 3.0 | View |
| Heart Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE Version 3.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE Version 3.0 | View |
| Obstuction--GI, small bowel | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE Version 3.0 | View |
| Edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE Version 3.0 | View |
| Other- Systemic inflammatory response syndrome (SIRS) | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE Version 3.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE Version 3.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE Version 3.0 | View |
| Altered mental status | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE Version 3.0 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE Version 3.0 | View |
| Hemorrhage, CNS (cerebrovascular) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE Version 3.0 | View |
| Adult Respiratory Distress Syndrome (ARDS) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 3.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| TMA/renal failure/hemolysis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE Version 3.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE Version 3.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE Version 3.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE Version 3.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE Version 3.0 | View |
| Hyperlipidemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE Version 3.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE Version 3.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE Version 3.0 | View |
| Confusion/psychosis/encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE Version 3.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE Version 3.0 | View |
| Hematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE Version 3.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE Version 3.0 | View |
| Respiratory | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE Version 3.0 | View |
| Hepatic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE Version 3.0 | View |
| Stomatitis/mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE Version 3.0 | View |
| Nausea/vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE Version 3.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE Version 3.0 | View |
| Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE Version 3.0 | View |
| Weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE Version 3.0 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE Version 3.0 | View |
| Allergic Reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE Version 3.0 | View |
| Cardiac | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE Version 3.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE Version 3.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE Version 3.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE Version 3.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE Version 3.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE Version 3.0 | View |