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 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:54 AM
NCT ID:
NCT03011034
Description:
Safety population included all participants who received at least 1 dose of study drug.
Frequency Threshold:
5
Time Frame:
Up to 2 years
Study:
NCT03011034
Study Brief:
Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Talacotuzumab | Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV). | 0 | None | 1 | 1 | 1 | 1 | View |
| Daratumumab | Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days. | 6 | None | 15 | 33 | 33 | 33 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Coronary Syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.0 | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.0 | View |
| Cardiac Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.0 | View |
| Cardiac Failure Congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.0 | View |
| Rectal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.0 | View |
| Autoimmune Disorder | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 21.0 | View |
| Corona Virus Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Lung Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Lung Infection Pseudomonal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.0 | View |
| Hand Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.0 | View |
| Rib Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.0 | View |
| Hypernatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.0 | View |
| Metabolic Acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.0 | View |
| Hepatic Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | View |
| Transient Ischaemic Attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.0 | View |
| Chronic Obstructive Pulmonary Disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | View |
| Laryngeal Oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | View |
| Thrombophlebitis Superficial | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 21.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.0 | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.0 | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 21.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Campylobacter Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Herpes Simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | View |
| Muscle Spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | View |
| Musculoskeletal Chest Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.0 | View |
| Dyspnoea Exertional | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.0 | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.0 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 21.0 | View |
| Conjunctival Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 21.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.0 | View |
| Peripheral Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Infusion Related Reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.0 | View |
| Blood Creatinine Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 21.0 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 21.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.0 | View |
| Type 2 Diabetes Mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.0 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.0 | View |
| Renal Impairment | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 21.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | View |
| Night Sweats | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 21.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 21.0 | View |
| Pallor | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 21.0 | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | View |