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 @ 3:39 AM
Ignite Modification Date: 2025-12-26 @ 2:24 AM
NCT ID: NCT05116202
Description: Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Frequency Threshold: 5
Time Frame: From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2)
Study: NCT05116202
Study Brief: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)
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: Tobemstomig + Tiragolumab Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13. 1 None 6 20 18 20 View
Cohort 2: Tobemstomig + Tiragolumab Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. 5 None 1 8 7 8 View
Cohort 1: Nivolumab + Ipilimumab (Control) Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13. 1 None 4 22 18 22 View
Cohort 1: Tobemstomig 2100 mg Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13. 1 None 9 40 34 40 View
Cohort 1: Atezolizumab + Tiragolumab Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13. 2 None 3 20 18 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Heart rate irregular SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Immune-mediated lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Lymphatic fistula SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Immune-mediated hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 27.0 View
Catheter site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Infected seroma SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Meningitis aseptic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Troponin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Hyperlipasaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Scar excision SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA version 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 27.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 27.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 27.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA version 27.0 View
Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA version 27.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA version 27.0 View
Thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA version 27.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 27.0 View
Eyelid ptosis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 27.0 View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 27.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Abdominal tenderness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Xerosis SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 27.0 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 27.0 View
Contrast media allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA version 27.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Post procedural constipation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Procedural nausea SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
International normalised ratio decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Serum ferritin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Troponin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hyperamylasaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Joint stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 27.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Sensory disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 27.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 27.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 27.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Lichenoid keratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View