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 @ 4:04 PM
Ignite Modification Date:
2025-12-25 @ 2:05 PM
NCT ID:
NCT04579666
Description:
RTP: Safety set included all subjects who received at least 1 dose of study treatment, pegcetacoplan or placebo. OLP: Safety set included only subjects who received at least 1 dose of the open-label treatment. RTP reporting groups: MedDRA 23.0.
Frequency Threshold:
5
Time Frame:
TEAEs, TESAEs and deaths were collected from first dose of study drug (RTP: Day 1/OLP: Week 52) up to 56 days post last dose of study drug, approximately 60 weeks each for RTP and OLP.
Study:
NCT04579666
Study Brief:
MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| RTP: Pegcetacoplan | Subjects received pegcetacoplan 1080 mg SC injection/infusion twice per week for 52 weeks. | 26 | None | 57 | 169 | 124 | 169 | View |
| RTP: Placebo | Subjects received placebo matching pegcetacoplan as SC injection/infusion twice per week for 52 weeks. | 11 | None | 27 | 80 | 55 | 80 | View |
| OLP: Pegcetacoplan/Pegcetacoplan | Eligible subjects who had received pegcetacoplan in RTP entered OLP and continued to receive pegcetacoplan 1080 mg SC injection/infusion twice per week for 52 weeks. | 10 | None | 24 | 97 | 31 | 97 | View |
| OLP: Placebo/Pegcetacoplan | Eligible subjects who had received placebo matching pegcetacoplan in RTP entered OLP to receive pegcetacoplan 1080 mg SC injection/infusion twice per week for 52 weeks. | 6 | None | 14 | 50 | 20 | 50 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 23.0 | View |
| Angina Pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 23.1 | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 23.1 | View |
| Cardiac Failure Acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 23.1 | View |
| Cardio-Respiratory Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 23.1 | View |
| Optic Atrophy | SYSTEMATIC_ASSESSMENT | Eye disorders | 23.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Disease Progression | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Cholecystitis Acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 23.1 | View |
| Hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 23.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 23.1 | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Covid-19 Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Febrile Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Pneumonia Moraxella | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Stoma Site Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Pneumonia Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Viral Rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Humerus Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Head Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Ankle Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Craniocerebral Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Weight Decreased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 23.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 23.1 | View |
| Food Refusal | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 23.1 | View |
| Hepatic Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | View |
| Metastatic Uterine Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | View |
| Colon Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | View |
| Invasive Ductal Breast Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | View |
| Musculoskeletal Chest Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Amyotrophic Lateral Sclerosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Bulbar Palsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Acute Stress Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 23.1 | View |
| Confusional State | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 23.1 | View |
| Device Dislocation | SYSTEMATIC_ASSESSMENT | Product Issues | 23.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 23.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 23.1 | View |
| Renal Colic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 23.1 | View |
| Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 23.1 | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Pneumonia Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Respiratory Disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Acute Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Obstructive Airways Disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Respiratory Distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Sleep Apnoea Syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Respiratory Symptom | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Bronchial Secretion Retention | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Ischaemic Skin Ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 23.1 | View |
| Hospitalisation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 23.1 | View |
| Gastrostomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 23.1 | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 23.1 | View |
| Hypovolaemic Shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | 23.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 23.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 23.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |