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: 2025-12-24 @ 2:38 PM
Ignite Modification Date: 2025-12-25 @ 1:10 PM
NCT ID: NCT02854059
Description: Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent AE (TEAE) was defined as any AE occurring after administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IdeS administration). AEs reported in ClinicalTrials.gov include TEAEs and post-TEAEs, i.e. all AEs occurring after administration of IdeS until end of study
Frequency Threshold: 0
Time Frame: Adverse events (AEs) were collected for a time-period of 3 months for the individual subject (i.e. from the subject signed the informed consent form (ICF) throughout the study including the follow-up period until the end of study visit).
Study: NCT02854059
Study Brief: IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment IdeS (0.25 mg/kg) A single 30 minutes i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of safety and efficacy in 3 patients receiving 0.25 mg/kg there will be a potential to increase the IdeS dose to 0.5 mg/kg for the remaining 3 patients. 0 None 2 2 2 2 View
Treatment IdeS (0.50 mg/kg) A single 30 minutes i.v. infusion of IdeS (0.50 mg/kg). 0 None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombotic thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (19.0) View
Serum sickness SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (19.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (19.0) View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (19.0) View