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 @ 2:12 AM
Ignite Modification Date: 2025-12-26 @ 12:40 AM
NCT ID: NCT00065260
Description: None
Frequency Threshold: 5
Time Frame: 3 years
Study: NCT00065260
Study Brief: Rabbit Antithymocyte Globulin Versus Campath-1H for Treating Severe Aplastic Anemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
r-ATG /Cyclosporine A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day). r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. 9 None 7 27 7 27 View
Alemtuzumab (Campath-1H) A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day). Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day). 4 None 12 27 12 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
infection NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (2.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
infection NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View