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 @ 5:06 PM
Ignite Modification Date:
2025-12-25 @ 2:45 PM
NCT ID:
NCT02345850
Description:
Adverse event (AE) reporting was conducted according to the BMT CTN's manual of operating procedures (MOP). Unexpected, grade 3-5 AE were reported through an expedited AE reporting system. Expected AEs were reported using National Cancer Institute (NCI)'s Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at regular intervals and reported in the secondary outcome "Toxicities". All fatal (Grade 5) expected adverse events were reported in an expedited manner.
Frequency Threshold:
0
Time Frame:
Adverse event reporting and monitoring were conducted throughout the study, up to 2 years.
Study:
NCT02345850
Study Brief:
Calcineurin Inhibitor-Free Interventions BMT CTN 1301 for Prevention of Graft-versus-Host Disease (BMT CTN 1301)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| CD34 Selected Graft | Mobilized CD34-selected Peripheral Blood Stem Cell graft Following screening and enrollment, the donor of patients randomized to the CD34-selection arm will receive mobilization therapy with once daily Granulocyte Colony Stimulating Factor (G-CSF). Mobilization will begin on Day -5 prior to the patient's transplant date. Leukapheresis will be performed on a continuous flow cell separator according to institutional standards and will commence on the morning of the fifth day of G-CSF treatment. The anti-coagulant used for the procedure will be acid citrate dextrose (ACD). Decisions concerning the need for further product collection will be based on the known or projected enriched CD34+ cell content of the previously collected products. Mobilized CD34-selected Peripheral Blood Stem Cell graft: Mobilized CD34-selected PBSC grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated. | 42 | None | 9 | 114 | 3 | 114 | View |
| Post-Transplant Cyclophosphamide | Unmanipulated Bone Marrow Graft with Cyclophosphamide Unmanipulated BM grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated. Cyclophosphamide: Mesna will be given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide or administered per institutional standards. Mesna dose will be based on the cyclophosphamide dose being given. The total daily dose of Mesna is equal to 80% of the total daily dose of cyclophosphamide. Cyclophosphamide 50 mg/kg will be given on Day 3 post-transplant (between 60 and 72 hours after marrow infusion) and on Day 4 post-transplant (approximately 24 hours after Day 3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours (depending on volume). | 27 | None | 7 | 114 | 1 | 114 | View |
| Tacrolimus/Methotrexate Control | Unmanipulated bone marrow graft with Tacrolimus/Methotrexate (Tac/MTX) GVHD prophylaxis. Tac will be maintained at therapeutic doses for a minimum of 90 days. Cyclosporine may be substituted for Tac if the patient is intolerant of tacrolimus or per institutional practice. MTX will be dosed at 10-15mg/m\^2 for a maximum of 4 doses post-transplant. Tac will be given orally or intravenously per institutional standards starting Day -3. The dose of Tac may be rounded to the nearest 0.5 mg for oral formulations. Subsequent dosing will be based on blood levels, with a target of 5-15 ng/ml. If patients are on medications which alter the metabolism of Tac (e.g. azoles), the initial starting dose and subsequent doses should be altered as per institutional practices. Tac taper can be initiated at a minimum of 90 days post HSCT if there is no evidence of active GVHD. The rate of tapering will be done according institutional practices but patients should be off tacrolimus by Day 180 post HSCT if there is no evidence of active GVHD. MTX will be administered at the doses of 15 mg/m\^2 IV bolus on Day +1, and 10 mg/m\^2 IV bolus on Days +3, +6 and +11 after hematopoietic stem cell infusion. The Day +1 dose of MTX should be given at least 24 hours after the hematopoietic stem cell infusion. Dose reduction of MTX due to worsening creatinine clearance after initiation of conditioning regimen, high serum levels or development of oral mucositis is allowed according to institutional practices. | 30 | None | 7 | 118 | 2 | 118 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| RETROPERITONEAL BLEED | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.0 | View |
| NON CARDIAC CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 20.0 | View |
| NEW MALIGNANCY-RECTAL ADENOCARCINOM | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.0 | View |
| SEPSIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.0 | View |
| SUDDEN CARDIAC ARREST | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 20.0 | View |
| HOSPITAL ADMISSION FOR INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.0 | View |
| DELIRIUM | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 20.0 | View |
| SUDDEN CARDIAC DEATH | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.0 | View |
| ATRIAL FIBRILLATION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.0 | View |
| DEATH | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 20.0 | View |
| SUPERIOR VENA CAVA SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.0 | View |
| EDEMA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 20.0 | View |
| COLONIC PERFORATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.0 | View |
| GASTRITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.0 | View |
| CHOLECYSTITIS | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 20.0 | View |
| RESPIRATORY FAILURE | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.0 | View |
| FETAL DEATH | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA version 20.0 | View |
| PLEURAL EFFUSION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.0 | View |
| DISSEMINATED ADENOVIRUS INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.0 | View |
| GRADE 3 UNEXPECTED WEIGHT LOSS | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 20.0 | View |
| WORSENING EYESIGHT DUE TO CATARACT | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 20.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ELEVATED FERRITIN | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 20.0 | View |
| FOLLICULAR LYMPHOMA | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.0 | View |
| RESPIRATORY FAILURE | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.0 | View |
| ARTHRALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 20.0 | View |
| ELEVATED ENDOTOXIN LEVEL | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA version 20.0 | View |
| PLATELET COUNT DECREASE | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 20.0 | View |