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: 2025-12-25 @ 12:22 AM
Ignite Modification Date: 2025-12-25 @ 10:26 PM
NCT ID: NCT03184558
Description: The safety set included all participants who were enrolled in the study and who received at least 1 dose of study product (bemcentinib and/or pembrolizumab).
Frequency Threshold: 0
Time Frame: Up to 1 year
Study: NCT03184558
Study Brief: Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With TNBC
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bemcentinib + Pembrolizumab Participants received Bemcentinib (BGB324) capsules orally once daily as a loading dose of 400 milligram (mg) on Days 1, 2, and 3. A dose of 200 mg pembrolizumab was given by intravenous infusion over 30 minutes every 3 weeks in all participants. Dosing of both drugs commenced on Day 1. On days when both BGB324 and pembrolizumab were given, pembrolizumab was given first and participants were observed for 1 hour after the end of infusion before BGB324 was administered. From Day 4 onward, participants received a daily maintenance dose of 200 mg along with Pembrolizumab 200 mg intravenous (IV) infusion over 30 minutes every 3 weeks until disease progression, until an unacceptable toxicity occurred that required treatment withdrawal or withdrawal of consent or until 106 weeks had passed. 16 None 22 29 29 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 18 View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDra 18 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDra 18 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDra 18 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDra 18 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDra 18 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDra 18 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 18 View
Rash generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 18 View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 18 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 18 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 18 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 18 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 18 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 18 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 18 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 18 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 18 View
Hypovolaemic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 18 View
Jugular vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 18 View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 18 View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 18 View
Hepatitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 18 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 18 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 18 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 18 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDra 18 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 18 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 18 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 18 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 18 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 18 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 18 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 18 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 18 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 18 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 18 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 18 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 18 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 18 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 18 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 18 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 18 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 18 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 18 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 18 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 18 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 18 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 18 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 18 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 18 View
Paraesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood thyroid stimulating hormone decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Tri-iodothyronine free decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Myopathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 18 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDra 18 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDra 18 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDra 18 View
Axillary pain SYSTEMATIC_ASSESSMENT General disorders MedDra 18 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDra 18 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDra 18 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 18 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 18 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDra 18 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDra 18 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Hemiparaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Movement disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Neurological symptom SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDra 18 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 18 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 18 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 18 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 18 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDra 18 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDra 18 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 18 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 18 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 18 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 18 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDra 18 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 18 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 18 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 18 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 18 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 18 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 18 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 18 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 18 View
Rash generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 18 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 18 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 18 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 18 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 18 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 18 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 18 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 18 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 18 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 18 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Suprapubic pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Palmar erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Lymph node pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Sinus pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Jugular vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Affect lability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Hepatotoxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Eyelid ptosis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Seborrhoeic keratosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View