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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 11:37 PM
NCT ID:
NCT02963493
Description:
The Safety Analysis Set for evaluation of adverse events included all patients who received at least one dose of melflufen or dexamethasone in the study. Patients that were triple-class refractory and those with extramedullary disease were defined as a subgroups of interest for evaluation.
Frequency Threshold:
5
Time Frame:
Patients were treated in 28 day cycles indefinitely until withdrawal from study, with the longest time on study of 17 months. Adverse events were collected until 30 days after the last dose of study drug. Patients were followed for survival for 24 months after disease progression or start of subsequent anti-myeloma therapy.
Study:
NCT02963493
Study Brief:
A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease | Patients with extramedullary disease at baseline defined as myeloma disease either originating in, but extending beyond, the cortical bone or as a separate soft tissue mass. | 51 | None | 38 | 55 | 55 | 55 | View |
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle. Melphalan flufenamide (Melflufen) Dexamethasone: IV dexamethasone may be substituted for oral dexamethasone in the US. Oral only in Europe. | 130 | None | 88 | 157 | 157 | 157 | View |
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | Triple class refractory population defined as refractory to or intolerant of at least one immunomodulatory drug, at least one proteasome inhibitor, and at least one anti-CD38 monoclonal antibody. | 105 | None | 70 | 119 | 119 | 119 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Soft tissue infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 19.1 | View |
| Lower gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 19.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| Squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 19.1 | View |
| Abdominal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Bacterial sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Bronchitis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Escherichia sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Fungal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Lower respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Pneumocystis jirovecii pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Pneumonia viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Respiratory tract infection viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| Methaemoglobinaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| Diffuse alveolar damage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| Face oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| Multiple organ dysfunction syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| Nephropathy | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 19.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 19.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Haemorrhoidal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 19.1 | View |
| Metabolic disorder | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 19.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| Pathological fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 19.1 | View |
| Cardiac amyloidosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 19.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 19.1 | View |
| Cardiopulmonary failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 19.1 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | View |
| Malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | View |
| Plasma cell leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | View |
| Plasma cell myeloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 19.1 | View |
| Hyperammonaemic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 19.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 19.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 19.1 | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA version 19.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Pneumonia pneumococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Pneumonia influenzal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Acute respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| Colitis ischaemic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Extradural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| Myelodysplastic syndrome | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | View |
| Refractory cytopenia with multilineage dysplasia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 19.1 | View |
| Cerecrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 19.1 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 19.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 19.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 19.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 19.1 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 19.1 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 19.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 19.1 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 19.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 19.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 19.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 19.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 19.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |