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 @ 4:58 PM
Ignite Modification Date: 2025-12-25 @ 2:39 PM
NCT ID: NCT05781750
Description: None
Frequency Threshold: 0
Time Frame: Through end of study visit, up to 52 weeks
Study: NCT05781750
Study Brief: A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zetomipzomib 60 mg + Standard-of-care Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy. 1 None 8 29 25 29 View
Zetomipzomib 30 mg + Standard-of-care Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy. 2 None 5 27 23 27 View
Placebo + Standard-of-care Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy. 1 None 3 28 17 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Dengue fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Gastroenteritis salmonella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Injection related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Squamous cell carcinoma of the tongue SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 27.0 View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Bipolar disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 27.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Hypovolaemic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Lupus vasculitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Injection site urticaria SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Localised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Genital herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Nasal herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Tinea infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Low density lipoprotein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Mean cell haemoglobin concentration decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Skin papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 27.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Paraparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Post herpetic neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Antisocial personality disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 27.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 27.0 View
Autism spectrum disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 27.0 View
Bipolar disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 27.0 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 27.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 27.0 View
Heavy menstrual bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 27.0 View
Menstruation irregular SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 27.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Hypersensitivity pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Post inflammatory pigmentation change SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Peripheral coldness SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 27.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 27.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 27.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA version 27.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA version 27.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View