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 @ 3:15 PM
Ignite Modification Date: 2025-12-25 @ 1:37 PM
NCT ID: NCT02624492
Description: None
Frequency Threshold: 5
Time Frame: Adverse events that started from the first administration of any trial medication to 30 days after the last administration; up to 114 days
Study: NCT02624492
Study Brief: To Determine the Dose of BI 836826-GemOx and the Efficacy of BI 836826-GemOx Versus R-GemOx in Patients With Relapsed/Refractory DLBCL
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BI 836826 100 mg + GemOx Patients were administered (intravenous infusion) BI 836826 100 mg on Day 8 and GemOx (gemcitabine 1000 mg/m\^2 plus oxaliplatin 100 mg/m\^2) on Day 1 (up to 6 cycles of treatment); the duration of each cycle was 14 days. 1 None 3 8 8 8 View
BI 836826 25 Milligram (mg) + GemOx Patients were administered (intravenous infusion) BI 836826 25 mg on Day 8 and GemOx (gemcitabine 1000 mg/metre square (m\^2) plus oxaliplatin 100 mg/m\^2) on Day 1 (up to 6 cycles of treatment); the duration of each cycle was 14 days. 0 None 4 5 5 5 View
BI 836826 50 mg + GemOx Patients were administered (intravenous infusion) BI 836826 50 mg on Day 8 and GemOx (gemcitabine 1000 mg/m\^2 plus oxaliplatin 100 mg/m\^2) on Day 1 (up to 6 cycles of treatment); the duration of each cycle was 14 days. 2 None 5 8 8 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Aspergillus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Device related infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Febrile nonhaemolytic transfusion reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Tumour lysis syndrome NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pancytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Oral dysaesthesia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Infusion site extravasation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Cytomegalovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Transaminases increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperuricaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Tetany NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Dysaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Dysarthria NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Decubitus ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Night sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Pallor NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View