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 @ 6:45 PM
Ignite Modification Date:
2025-12-25 @ 4:16 PM
NCT ID:
NCT02100657
Description:
None
Frequency Threshold:
5
Time Frame:
Participants were assessed through study completion, approximately 4 years
Study:
NCT02100657
Study Brief:
Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With 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 |
|---|---|---|---|---|---|---|---|---|
| Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg) | Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles | 1 | None | 5 | 8 | 8 | 8 | View |
| Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg) | Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles | 0 | None | 3 | 4 | 4 | 4 | View |
| Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg) | Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles | 1 | None | 12 | 24 | 24 | 24 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.0) | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.0) | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.0) | View |
| tumour pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | View |
| atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.0) | View |
| acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.0) | View |
| cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.0) | View |
| lung disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.0) | View |
| hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (16.0) | View |
| spinal cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.0) | View |
| bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.0) | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| escherichia infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| pneumonia pneumococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| respiratory syncytial virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.0) | View |
| tumour pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | View |
| asthenia/fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| feeling of body temperature change | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.0) | View |
| insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.0) | View |
| humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.0) | View |
| upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.0) | View |
| wrist fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.0) | View |
| fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.0) | View |
| scapula fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.0) | View |
| weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.0) | View |
| blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.0) | View |
| atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.0) | View |
| cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.0) | View |
| thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.0) | View |
| neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.0) | View |
| aphonia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| polyneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| conjunctival haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (16.0) | View |
| vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (16.0) | View |
| deafness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (16.0) | View |
| abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.0) | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.0) | View |
| bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| myopathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.0) | View |
| hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.0) | View |
| hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.0) | View |
| bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| phlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.0) | View |
| cataract operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (16.0) | View |
| alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.0) | View |
| aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.0) | View |
| neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.0) | View |
| arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |