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 @ 3:06 PM
Ignite Modification Date: 2025-12-25 @ 1:28 PM
NCT ID: NCT04294459
Description: Analysis was performed on all treated population.
Frequency Threshold: 5
Time Frame: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)
Study: NCT04294459
Study Brief: Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort A: Participants With cPRA >=99.90% Participants with cPRA \>=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). 1 None 0 12 3 12 View
Cohort B: Participants With cPRA 80.00% to 99.89% Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). 0 None 0 11 4 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 25.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 25.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 25.0 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 25.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 25.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 25.0 View
Temporomandibular Joint Syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 25.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDra 25.0 View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 25.0 View