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 @ 2:07 PM
Ignite Modification Date: 2025-12-25 @ 12:49 PM
NCT ID: NCT03787095
Description: AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
Frequency Threshold: 0
Time Frame: Study entry through week 48 or premature discontinuation.
Study: NCT03787095
Study Brief: Safety and Immunotherapeutic Activity of an Anti-PD-1 Antibody (Cemiplimab) in Participants With HIV-1 on Suppressive cART
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 1: Cemiplimab Participants received 0.3 mg/kg of cemiplimab, with planned administration at Day 0 and Week 6 for a total of two infusions. Participants continued their current non-study provided ART regimen. Cemiplimab: Administered as an intravenous (IV) infusion 0 None 1 4 4 4 View
Cohort 1: Placebo Participants received placebo, with planned administration at Day 0 and Week 6 for a total of two infusions. Participants continued their current non-study provided ART regimen. Placebo: Diluent for REGN2810 , administered as an IV infusion 0 None 0 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.0 View
Blood thyroid stimulating hormone decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Thyroxine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood phosphorus decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood thyroid stimulating hormone decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Creatinine renal clearance decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View