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 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
NCT ID:
NCT03846427
Description:
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
Frequency Threshold:
3
Time Frame:
From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Study:
NCT03846427
Study Brief:
Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Zanubrutinib | Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent | 13 | None | 30 | 68 | 61 | 68 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra 24.0 | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra 24.0 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 24.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 24.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 24.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | meddra 24.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | meddra 24.0 | View |
| Bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | meddra 24.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | meddra 24.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Respiratory syncytial virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Septic encephalopathy | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Acetabulum fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra 24.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra 24.0 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra 24.0 | View |
| Pelvic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra 24.0 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 24.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 24.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra 24.0 | View |
| Organising pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | meddra 24.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 24.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 24.0 | View |
| Acute myeloid leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | View |
| Bladder cancer recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | View |
| Papillary thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | View |
| Cerebellar infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 24.0 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 24.0 | View |
| Vertebrobasilar insufficiency | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 24.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 24.0 | View |
| Coronary artery stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 24.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Faecaloma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Large intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra 24.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra 24.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra 24.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 24.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | meddra 24.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | meddra 24.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | meddra 24.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 24.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra 24.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra 24.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 24.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 24.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 24.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 24.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 24.0 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 24.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 24.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra 24.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra 24.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra 24.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra 24.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 24.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 24.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 24.0 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 24.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra 24.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra 24.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra 24.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra 24.0 | View |