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 @ 7:36 PM
Ignite Modification Date: 2025-12-25 @ 5:16 PM
NCT ID: NCT05096403
Description: All safety analyses were carried out descriptively on the safety set and presented by randomization sequence. For each output summary, all data was presented as it became available. For example, data for Part A was presented when Part A was reported. When Part B data are available, all cumulative data from Parts A and B will be reported together. The data was presented by Part A and Part B.
Frequency Threshold: 5
Time Frame: Through study completion and follow-up for up to 104 weeks (24 months approximately).
Study: NCT05096403
Study Brief: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pegcetacoplan Double Blind During Part A Initially assigned in Part A. 1 None 5 16 16 16 View
Placebo Matching Pegcetacoplan-Double-blind During Part A Initially assigned in Part A. 0 None 1 8 8 8 View
Open-label Pegcetacoplan During Parts B and C Initially assigned in Part A 0 None 6 14 12 14 View
Open-label Pegcetacoplan (Placebo Matching Pegcetacoplan during Part A) During Parts B&C Initially assigned in Part A 0 None 1 7 4 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Covid-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cholecystitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Enterococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Haemolytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Syncope SYSTEMATIC_ASSESSMENT General disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Autoimmune haemolytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Breakthrough haemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cold type haemolytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Haemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Osteonecrosis of jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cold type haemolytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Haemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoprothrombinaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Fungal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Haemolytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Chillblains SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cold exposure injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Induration SYSTEMATIC_ASSESSMENT General disorders None View
Injection site paraesthesia SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders None View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Injection site mass SYSTEMATIC_ASSESSMENT General disorders None View
Performance status decreased SYSTEMATIC_ASSESSMENT General disorders None View
Bacteriuria SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations None View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal rigidity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Epigastric discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haemorrhage subcutaneous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Asteatosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Warm autoimmune haemolytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders None View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders None View
Eyelid ptosis SYSTEMATIC_ASSESSMENT Eye disorders None View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular pseudohole SYSTEMATIC_ASSESSMENT Eye disorders None View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Haemosiderosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shoulder girdle pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Haemangioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Seborrhoeic keratosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombin-antithrombin III complex increased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Slow response to stimuli SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Alcohol withdrawal syndrome SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Scrotal oedema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cyanosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral coldness SYSTEMATIC_ASSESSMENT Vascular disorders None View
Cardiac cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View