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 @ 7:35 PM
Ignite Modification Date: 2025-12-25 @ 5:16 PM
NCT ID: NCT05179603
Description: Analysis was performed on the exposed population.
Frequency Threshold: 5
Time Frame: Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months.
Study: NCT05179603
Study Brief: A Study of SAR444245 With or Without Other Anticancer Therapies for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Lymphoma (Master Protocol) [Pegathor Lymphoma 205]
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: Pegenzileukin 24 μg/kg + Pembrolizumab Participants with cHL who were anti-PD-L1-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 μg/kg via IV infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 mg via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as 3/4L therapy, until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. 0 None 5 14 14 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Urinary Tract Infection Fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Cytokine Release Syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDra 27.0 View
Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDra 27.0 View
Immune-Mediated Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDra 27.0 View
Immune-Mediated Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.0 View
Immune-Mediated Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Dengue Fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Oral Herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Respiratory Tract Infection Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Viral Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Viral Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Cytokine Release Syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDra 27.0 View
Glucocorticoid Deficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDra 27.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDra 27.0 View
Immune-Mediated Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDra 27.0 View
Thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDra 27.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDra 27.0 View
Vitreous Floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDra 27.0 View
Vasculitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 27.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.0 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Rash Erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Rash Maculo-Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Skin Hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Vitiligo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Joint Stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Urinary Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 27.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Swelling Face SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.0 View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.0 View
Blood Alkaline Phosphatase Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.0 View
Blood Bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.0 View
Blood Sodium Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.0 View
Blood Thyroid Stimulating Hormone Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.0 View
Lymphocyte Count Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.0 View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.0 View