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: 2025-12-25 @ 4:06 AM
Ignite Modification Date: 2025-12-26 @ 3:02 AM
NCT ID: NCT01083602
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01083602
Study Brief: Efficacy of Panobinostat in Patients With Relapsed and Bortezomib-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
PAN + BTZ + Dex PAN + BTZ + Dex None None 39 55 53 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diverticulum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hepatic ischaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Parainfluenzae virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Alcohol poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypophagia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Peroneal nerve palsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Alcoholism SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View