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 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
NCT ID:
NCT03342404
Description:
None
Frequency Threshold:
5
Time Frame:
From first dose to 63 days after last dose (up to approximately 56 months)
Study:
NCT03342404
Study Brief:
A Study to Determine the Efficacy and Safety of Luspatercept in Adults With Non Transfusion Dependent Beta (β)-Thalassemia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Luspatercept | Luspatercept was administered as subcutaneous injection once every 3 weeks (administered on Study Day 1 of each 21-day treatment cycle). The starting dose level was 1.00 mg/kg and could be escalated to 1.25 mg/kg and/or reduced to 0.80, 0.60, and 0.45 mg/kg. Participants were treated for a minimum of 48 weeks. | 1 | None | 23 | 96 | 96 | 96 | View |
| Placebo | Placebo (0.9% sodium chloride for injection) was administered as subcutaneous injection once every 3 weeks (administered on Study Day 1 of each 21-day treatment cycle) for a minimum of 48 weeks. Eligible participants entered an open-label phase and started Luspatercept treatment for up to approximately 24 months. | 0 | None | 13 | 49 | 48 | 49 | View |
| Open-Label Placebo-Luspatercept | Open-label phase in which participants switched from placebo and started Luspatercept treatment for up to approximately 24 months. | 0 | None | 3 | 38 | 38 | 38 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 25.1 | View |
| Extramedullary haemopoiesis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 25.1 | View |
| Splenomegaly | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 25.1 | View |
| Cardiac failure acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 25.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 25.1 | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 25.1 | View |
| Ventricular hypokinesia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 25.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 25.1 | View |
| Bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 25.1 | View |
| Biliary colic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 25.1 | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 25.1 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 25.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 25.1 | View |
| Abscess limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Dengue haemorrhagic fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Pilonidal disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Pyelonephritis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.1 | View |
| Pulmonary contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.1 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.1 | View |
| Traumatic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.1 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | 25.1 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.1 | View |
| Hypovolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.1 | View |
| Steroid diabetes | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.1 | View |
| Diffuse large B-cell lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | View |
| Hepatocellular carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | View |
| Spinal cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.1 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.1 | View |
| Abortion spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | 25.1 | View |
| Pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | 25.1 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 25.1 | View |
| Renal colic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 25.1 | View |
| Ovarian cyst ruptured | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 25.1 | View |
| Prostatic obstruction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 25.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.1 | View |
| Haemothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.1 | View |
| Pulmonary arterial hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.1 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.1 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Helicobacter infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Iron overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.1 | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Extramedullary haemopoiesis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 25.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 25.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 25.1 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 25.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 25.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 25.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 25.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 25.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | 25.1 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | 25.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | 25.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 25.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | 25.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 25.1 | View |
| Biliary colic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 25.1 | View |
| Immunisation reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | 25.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 25.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.1 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.1 | View |
| Muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.1 | View |
| Traumatic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 25.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 25.1 | View |
| Folate deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.1 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 25.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Spinal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 25.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.1 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 25.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 25.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 25.1 | View |
| Albuminuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 25.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 25.1 | View |
| Renal cyst | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 25.1 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 25.1 | View |
| Menstruation irregular | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 25.1 | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 25.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.1 | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.1 | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.1 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 25.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 25.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 25.1 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 25.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 25.1 | View |
| Prehypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 25.1 | View |