Adverse Events Module

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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 @ 7:43 PM
Ignite Modification Date: 2025-12-25 @ 5:21 PM
NCT ID: NCT00229203
Description: 32 patients were treated with plitidepsin as single agent;afterwards 19 of them were treated with plitidepsin+dexamethasone combination.Therefore 32+19=51 is the no. patients at risk for plitidepsin and 19 is no. of patients at risk for dexamethasone
Frequency Threshold: 5
Time Frame: None
Study: NCT00229203
Study Brief: A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing 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
Plitidepsin Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks. None None 32 51 51 51 View
Plitidepsin + Dexamethasone Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion. None None 11 19 19 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation None Cardiac disorders None View
Atrial flutter None Cardiac disorders None View
Cardiac failure congestive None Cardiac disorders None View
Cardiomyopathy NOS None Cardiac disorders None View
Pulmonary oedema NOS None Cardiac disorders None View
Abdominal pain upper None Gastrointestinal disorders None View
Gastrointestinal haemorrhage NOS None Gastrointestinal disorders None View
Catheter site haemorrhage None General disorders None View
Fatigue None General disorders None View
Injection site cellulitis None General disorders None View
Multi-organ failure None General disorders None View
Pyrexia None General disorders None View
Sudden death None General disorders None View
Cholestasis None Hepatobiliary disorders None View
Hypersensitivity NOS None Immune system disorders None View
Bronchitis acute NOS None Infections and infestations None View
Herpes zoster None Infections and infestations None View
Pneumonia NOS None Infections and infestations None View
Respiratory tract infection NOS None Infections and infestations None View
Septic shock None Infections and infestations None View
Upper respiratory tract infection NOS None Infections and infestations None View
Urinary tract infection NOS None Infections and infestations None View
Blood creatine phosphokinase increased None Investigations None View
Hypercalcaemia None Metabolism and nutrition disorders None View
Bone pain None Musculoskeletal and connective tissue disorders None View
Muscle weakness NOS None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Myopathy None Musculoskeletal and connective tissue disorders None View
Myopathy toxic None Musculoskeletal and connective tissue disorders None View
Cerebrovascular accident None Nervous system disorders None View
Cervical cord compression None Nervous system disorders None View
Cognitive disorder None Nervous system disorders None View
Metabolic encephalopathy NOS None Nervous system disorders None View
Parkinsonism None Nervous system disorders None View
Quadriparesis None Nervous system disorders None View
Confusional state None Psychiatric disorders None View
Acute pre-renal failure None Renal and urinary disorders None View
Renal failure NOS None Renal and urinary disorders None View
Acute pulmonary oedema None Respiratory, thoracic and mediastinal disorders None View
Bronchospasm NOS None Respiratory, thoracic and mediastinal disorders None View
Dyspnoea NOS None Respiratory, thoracic and mediastinal disorders None View
Pleural effusion None Respiratory, thoracic and mediastinal disorders None View
Pneumonitis NOS None Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism None Respiratory, thoracic and mediastinal disorders None View
Respiratory failure None Respiratory, thoracic and mediastinal disorders None View
Poor peripheral circulation None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vision blurred None Eye disorders None View
Abdominal distension None Gastrointestinal disorders None View
Abdominal pain NOS None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhoea NOS None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Haemorrhoids None Gastrointestinal disorders None View
Hiatus hernia None Gastrointestinal disorders None View
Hiccups None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Rectal haemorrhage None Gastrointestinal disorders None View
Vomiting NOS None Gastrointestinal disorders None View
Chest pain None General disorders None View
Fatigue None General disorders None View
Injection site reaction NOS None General disorders None View
Oedema peripheral None General disorders None View
Pain NOS None General disorders None View
Pyrexia None General disorders None View
Rigors None General disorders None View
Weakness None General disorders None View
Hepatic disorder NOS None Hepatobiliary disorders None View
Hepatotoxicity NOS None Hepatobiliary disorders None View
Bronchitis NOS None Infections and infestations None View
Bronchitis acute NOS None Infections and infestations None View
Herpes simplex None Infections and infestations None View
Infection NOS None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Oral candidiasis None Infections and infestations None View
Respiratory tract infection NOS None Infections and infestations None View
Upper respiratory tract infection NOS None Infections and infestations None View
Urinary tract infection NOS None Infections and infestations None View
Laceration None Injury, poisoning and procedural complications None View
Blood amylase increased None Investigations None View
Blood creatine phosphokinase None Investigations None View
Blood creatine phosphokinase increased None Investigations None View
Blood myoglobin increased None Investigations None View
Glucose urine present None Investigations None View
Weight decreased None Investigations None View
X-ray NOS chest abnormal None Investigations None View
Anorexia None Metabolism and nutrition disorders None View
Fluid overload None Metabolism and nutrition disorders None View
Hyperglycaemia NOS None Metabolism and nutrition disorders None View
Hypocalcaemia None Metabolism and nutrition disorders None View
Hypokalaemia None Metabolism and nutrition disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Bone pain None Musculoskeletal and connective tissue disorders None View
Muscle cramps None Musculoskeletal and connective tissue disorders None View
Muscle weakness NOS None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Myopathy toxic None Musculoskeletal and connective tissue disorders None View
Osteonecrosis None Musculoskeletal and connective tissue disorders None View
Pain in limb None Musculoskeletal and connective tissue disorders None View
Cognitive disorder None Nervous system disorders None View
Dysgeusia None Nervous system disorders None View
Headache NOS None Nervous system disorders None View
Hypoaesthesia None Nervous system disorders None View
Paraesthesia None Nervous system disorders None View
Peripheral neuropathy NOS None Nervous system disorders None View
Agitation None Psychiatric disorders None View
Anxiety None Psychiatric disorders None View
Confusional state None Psychiatric disorders None View
Depression None Psychiatric disorders None View
Insomnia None Psychiatric disorders None View
Albuminuria None Renal and urinary disorders None View
Haematuria None Renal and urinary disorders None View
Haemoglobinuria None Renal and urinary disorders None View
Proteinuria None Renal and urinary disorders None View
Renal failure NOS None Renal and urinary disorders None View
Catarrh None Respiratory, thoracic and mediastinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dyspnoea NOS None Respiratory, thoracic and mediastinal disorders None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Hoarseness None Respiratory, thoracic and mediastinal disorders None View
Nasal congestion None Respiratory, thoracic and mediastinal disorders None View
Pharyngitis None Respiratory, thoracic and mediastinal disorders None View
Pleural effusion None Respiratory, thoracic and mediastinal disorders None View
Pulmonary vascular disorder NOS None Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea None Respiratory, thoracic and mediastinal disorders None View
Folliculitis None Skin and subcutaneous tissue disorders None View
Deep venous thrombosis NOS None Vascular disorders None View
Hypotension NOS None Vascular disorders None View
Anaemia NOS None Blood and lymphatic system disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
Atrial fibrillation None Cardiac disorders None View
Cardiomegaly NOS None Cardiac disorders None View
Palpitations None Cardiac disorders None View
Hypoacusis None Ear and labyrinth disorders None View
Vertigo None Ear and labyrinth disorders None View
Lacrimation increased None Eye disorders None View