Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:57 PM
Ignite Modification Date: 2025-12-25 @ 2:00 PM
NCT ID: NCT00578292
Description: All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
Frequency Threshold: 0
Time Frame: Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
Study: NCT00578292
Study Brief: Allogeneic Stem Cell Transplantation, Severe Homzygous 0/+Thalassemia or Sever Variants of Beta 0/+ Thalassemia, THALLO
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bone Marrow or Stem Cell Infusion Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0. Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor. Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg Days -9 through -6 Fludarabine: 30mg/m2 Day -5 through Day -2 Campath 1H: Per institutional guidelines Days -5 through -2 Cyclophosphamide: 50 mg/kg Days -5 through -2 MESNA: 10 mg/kg x 5 Days -5 through -2 1 None 4 10 9 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Catheter related Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Cardiac disorders-Other: Cardiomegaly SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Catheter Related Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Dysuria (painful urination) SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
GGT increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Hemoglobinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Cystitis noninfective SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Hepatobiliary disorders-Other: GVHD SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE 4.0 View
Hepatobiliary disorders-Other: hepatic VOD SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE 4.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Infections and infestations - Other: Parainfluenza virus SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Infections and infestations - Other: CMV reactivation SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Infections and infestations - Other: Gram negative rods SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Infections and infestations - Other: BK virus SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Infections and infestations - Other: HSV SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Lipase SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Anal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Nervous system disorders-Other: Altered mental status SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Partial thromboplastin time (PTT) SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Pelvic Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Prothrombin time (PT) SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Renal and urinary disorders-Other: Nitrite in urine SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Stomatitis/Pharyngitis (oral/pharyngeal mucositis) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Urine discoloration SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Wound-Infectious SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
Eye disorders -Other: PRES SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 4.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View