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 @ 11:37 PM
Ignite Modification Date: 2025-12-25 @ 9:27 PM
NCT ID: NCT04034056
Description: Safety population included all participants who were enrolled in the study.
Frequency Threshold: 5
Time Frame: All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months)
Study: NCT04034056
Study Brief: Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Obinutuzumab Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days). 54 None 121 299 113 299 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 27.2 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 27.2 View
Intestinal ischaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 27.2 View
Large intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 27.2 View
Malabsorption SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 27.2 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 27.2 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 27.2 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 27.2 View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 27.2 View
Cholangiocarcinoma SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 27.2 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA Version 27.2 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 27.2 View
Coronavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 27.2 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 27.2 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 27.2 View
Cytomegalovirus infection reactivation SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 27.2 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 27.2 View
Post-acute COVID-19 syndrome SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 27.2 View
Psoas abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 27.2 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 27.2 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 27.2 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 27.2 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 27.2 View
Cervical vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 27.2 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 27.2 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 27.2 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 27.2 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 27.2 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.2 View
Endometrial adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.2 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.2 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.2 View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 27.2 View
Monoplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 27.2 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 27.2 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 27.2 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 27.2 View
Alveolitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 27.2 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 27.2 View
Lung consolidation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 27.2 View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 27.2 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 27.2 View
Pleural thickening SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 27.2 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 27.2 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 27.2 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 27.2 View
Renal stone removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA Version 27.2 View
Ureteric calculus removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA Version 27.2 View
Uterine polypectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA Version 27.2 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 27.2 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 27.2 View
Jugular vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 27.2 View
Vena cava thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 27.2 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 27.2 View
Lymphoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 27.2 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 27.2 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 27.2 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 27.2 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 27.2 View
Dyspnoea SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 27.2 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 27.2 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 27.2 View
Hyperparathyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA Version 27.2 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 27.2 View
Colon cancer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 27.2 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 27.2 View