Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 1:35 PM
Ignite Modification Date: 2025-12-25 @ 12:35 PM
NCT ID: NCT03645395
Description: Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
Frequency Threshold: 0
Time Frame: All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Study: NCT03645395
Study Brief: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Lenalidomide for the Treatment of Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (MT-3724_NHL_003)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part 1: MT-3724 10 mcg/Kg-LEN Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle. 0 None 1 3 3 3 View
Part 1: MT-3724 25 mcg/Kg-LEN Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle. 0 None 1 3 3 3 View
Part 1: MT-3724 20 mcg/Kg-LEN Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle. 0 None 1 3 3 3 View
Part 2: MT-3724 50mcg/Kg-LEN Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle. 0 None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Capillary leak syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20 View
Capillary leak syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Glycosuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Diastolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Hypoproteinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20 View
Left atrial enlargement SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20 View
Oral disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20 View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20 View
Transaminase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20 View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20 View