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 @ 7:44 PM
Ignite Modification Date: 2025-12-25 @ 5:22 PM
NCT ID: NCT02151903
Description: Safety population included all enrolled participants who received at least 1 dose of study drug.
Frequency Threshold: 0
Time Frame: First dose of study drug up to EOS (up to 20 months)
Study: NCT02151903
Study Brief: Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Participants With B-cell NHL
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DI-Leu16-IL2 1.0 mg/m^2 Participants received DI-Leu16-IL2 1.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. 0 None 2 3 3 3 View
DI-Leu16-IL2 2.0 mg/m^2 Participants received DI-Leu16-IL2 2.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. 0 None 0 2 1 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Melena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection site oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Hematocrit decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Protein total increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Neurotoxicity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Nystagmus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Ligament injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Upper respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Cerumen impaction SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Injection site inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection site mass SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Hypogammaglobulinaemia SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.1 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Acoustic neuroma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Urine odour abnormal SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Dry throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View