Adverse Events Module

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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 @ 2:07 AM
Ignite Modification Date: 2025-12-26 @ 12:33 AM
NCT ID: NCT03480360
Description: None
Frequency Threshold: 0
Time Frame: Monitoring of all acute toxicities (grade 3 or higher) occurred until the time of discharge (post-transplant). After discharge, until day 100, only serious toxicities (grade 4 or higher) were recorded. All-Cause Mortality was monitored from the time of transplant to three years post-transplant.
Study: NCT03480360
Study Brief: Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Johns Hopkins' Conditioning Regimen Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant Cyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4) Fludarabine: 30 mg/m2 daily for 5 days Total Body Irradiation: 200 centigray (cGy) for one day (day -1) Tacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180. cellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation. g-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \> 1000/mcL for 3 days. Peripheral Blood Transplant: cell dose goal: \< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight 5 None 3 20 16 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Edema Limbs NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC 4.0 View
GI GVHD NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC 4.0 View
Liver GVHD NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI CTC 4.0 View
Skin GVHD NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTC 4.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC 4.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations NCI CTC 4.0 View
Encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTC 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rigors NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC 4.0 View
Encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTC 4.0 View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTC 4.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC 4.0 View
Anorexia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC 4.0 View
Edema NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC 4.0 View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC 4.0 View
Dysrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTC 4.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC 4.0 View
C. Diff NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTC 4.0 View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTC 4.0 View
Cytokine release syndrome NON_SYSTEMATIC_ASSESSMENT Immune system disorders NCI CTC 4.0 View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTC 4.0 View
Dysesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTC 4.0 View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC 4.0 View
Central Line NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC 4.0 View