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 @ 12:19 AM
Ignite Modification Date: 2025-12-25 @ 10:22 PM
NCT ID: NCT01659658
Description: All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
Frequency Threshold: 5
Time Frame: From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
Study: NCT01659658
Study Brief: Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physicians Choice of Treatment in Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A: Ixazomib + Dexamethasone Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. 40 None 44 90 86 90 View
Arm B: Dexamethasone + Cyclophosphamide Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months. 4 None 2 10 9 10 View
Arm B: Dexamethasone + Melphalan Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months. 14 None 11 26 24 26 View
Arm B: Dexamethasone + Thalidomide Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months. 0 None 0 1 1 1 View
Arm B: Dexamethasone + Lenalidomide Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months. 22 None 17 47 46 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Cardiac amyloidosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Colorectal adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Coronary artery dissection SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Gastric antral vascular ectasia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Herpes zoster cutaneous disseminated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Jaw cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Klebsiella bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 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
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Peripheral artery thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Plasma cell myeloma 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 chlamydial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Pneumonia fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Post herpetic neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Pulmonary oedema 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 haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Spinal cord infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Steroid diabetes SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Sudden cardiac death SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25 View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
Anal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 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
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Mood altered SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25 View
Mood swings SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Myopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Taste disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
Tongue haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 25 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View