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 @ 4:09 AM
Ignite Modification Date: 2025-12-26 @ 3:06 AM
NCT ID: NCT05061420
Description: Analysis was performed on the exposed population.
Frequency Threshold: 5
Time Frame: AEs and SAEs were collected from first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to approximately 28 months (Cohort A1), 27 months (Cohort B1) and 26 months (Cohort B2). All-cause mortality (deaths) were collected from first dose of study treatment administration (Day 1) to the end of follow-up for death for each participant, up to approximately 30 months.
Study: NCT05061420
Study Brief: A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CohortA1:R/M HNSCC Treatment-naïve for R/M Disease:Pegenzileukin 24mcg/kg+Pembrolizumab as 1LTherapy Participants with HNSCC who were treatment-naïve for R/M disease with PD-L1 CPS \>=1 were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE, other full permanent discontinuation criteria was met or completion of Cycle 35. 8 None 11 20 20 20 View
Cohort B1: R/M HNSCC: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy Participants with R/M HNSCC previously treated with PD1/PD-L1-based regimen and platinum-based regimen after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE, other full permanent discontinuation criteria was met or completion of Cycle 35. 13 None 11 20 18 20 View
Cohort B2: R/M HNSCC: Pegenzileukin 24 mcg/kg + Cetuximab as 2/3L Therapy Participants with R/M HNSCC previously treated with platinum-based regimen and cetuximab-naïve after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m\^2 on Cycle 1 Day 1 followed by 250 mg/m\^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 2/3L therapy) until PD. 10 None 8 19 19 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Obstructive Airways Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.1 View
Wound Haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.1 View
Abscess Neck SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Atypical Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Catheter Site Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Staphylococcal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Cytokine Release Syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDra 27.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.1 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.1 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View
Acute Cardiac Event SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.1 View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.1 View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.1 View
Cardio-Respiratory Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.1 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.1 View
Capillary Leak Syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 27.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 27.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
General Physical Health Deterioration SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Systemic Inflammatory Response Syndrome SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Gastrostomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDra 27.1 View
Device Occlusion SYSTEMATIC_ASSESSMENT Product Issues MedDra 27.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Localised Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Oral Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Oral Herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDra 27.1 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.1 View
Tongue Ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Cellulite SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Decubitus Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Dermatitis Acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Night Sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Onycholysis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Palmar-Plantar Erythrodysaesthesia Syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Rash Maculo-Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Rash Vesicular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Skin Discharge SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Skin Swelling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Skin Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.1 View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.1 View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.1 View
Pathological Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.1 View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 27.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 27.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 27.1 View
Adverse Drug Reaction SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Feeling Hot SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Hyperpyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Influenza Like Illness SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Xerosis SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Blood Alkaline Phosphatase Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Blood Bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Blood Calcium Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Blood Glucose Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Blood Magnesium Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Blood Phosphorus Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Blood Pressure Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Blood Thyroid Stimulating Hormone Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Weight Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.1 View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.1 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Post Procedural Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.1 View
Hyperleukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.1 View
Panic Attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.1 View
Brain Fog SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View
Eye Pain SYSTEMATIC_ASSESSMENT Eye disorders MedDra 27.1 View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDra 27.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDra 27.1 View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 27.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 27.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Lung Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Nasal Inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Pharyngeal Haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Oral Dysaesthesia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Salivary Hypersecretion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.1 View
Cytokine Release Syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDra 27.1 View
Cell Death SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.1 View