Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:00 AM
Ignite Modification Date: 2025-12-25 @ 9:57 PM
NCT ID: NCT02312258
Description: All-cause mortality= ITT Population included all participants who were randomized and had post-randomization data. Serious and Other Adverse Events: Safety population included all participants who received at least 1 dose of ixazomib or placebo. Three participants assigned to placebo arm each received a single 3 mg dose of ixazomib. These participants were excluded from the placebo arm and included in the ixazomib arm in the safety population.
Frequency Threshold: 5
Time Frame: First dose of study drug through 30 days after last dose of study drug (up to 88 months)
Study: NCT02312258
Study Brief: A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ixazomib Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26. 184 None 101 426 340 426 View
Placebo Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26. 115 None 48 276 188 276 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
Paraneoplastic pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Plasma cell myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Plasmacytoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Postmenopausal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
Rectal prolapse SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Soft tissue injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Subcapsular renal haematoma SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Transitional cell cancer of the renal pelvis and ureter SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Trismus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Uveitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Endometrial hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Gastric disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Gastroenteritis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Gastrointestinal motility disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Hypertensive emergency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Invasive ductal breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Jugular vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Large intestine polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Metastatic malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Monoparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Non-small cell lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Oesophageal carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Osteolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Abdominal wall abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Bladder transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Carcinoma in situ of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Chilaiditi's syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Tendon injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View