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 @ 9:08 PM
Ignite Modification Date: 2025-12-25 @ 6:58 PM
NCT ID: NCT02650804
Description: Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Frequency Threshold: 5
Time Frame: Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor.
Study: NCT02650804
Study Brief: BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BPM31510 Plus Gemcitabine BPM31510 Nanosuspension Injection (40 mg/mL) will be administered IV over 144 hours at the starting dose of 110 mg/kg. Each patient will receive 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday). The patient will be subsequently treated with gemcitabine IV once weekly at a starting dose of 1000 mg/m2. Cycle 1 of combination therapy is 6 weeks in duration for patients with BPM31510 administered twice weekly on Tuesdays and Fridays for 6 weeks and gemcitabine administered on Mondays, Days 21, 28 and 35. Cycles 2-12 are 4 weeks in duration with BPM31510 administered twice weekly on Tuesdays and Fridays for 4 weeks and gemcitabine administered on Mondays, Days 7, 14 and 21. BPM31510 Nanosuspension Injection Gemcitabine 28 None 12 28 28 28 View
BPM31510 Monotherapy BPM31510 IV nanosuspension injection (40mg/mL) was administered over 144 hours (two 72-hour 110 mg/Kg doses per week). Each patient received 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday). 17 None 10 17 16 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Disseminated intravascular coagulation. NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Duodenal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Erosive oesophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastric haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Large intestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Upper gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Cholangitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Hepatic failure NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Bacterial sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Spinal fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
International normalised ratio increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Metastases to central nervous system NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Splenic infarction NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Cardiomegaly NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Lip ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Catheter site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Catheter site extravasation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Catheter site haemorrhage NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Catheter site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Early satiety NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Bile duct stenosis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Jaundice NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Ocular icterus NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Liver abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Ligament sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Skin abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Activated partial thromboplastin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
C-reactive protein increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Coronavirus test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Fibrin d dimer increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
International normalised ratio NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
International normalised ratio increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Liver function test increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Prothrombin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Dysaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Lethargy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Memory impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Needle issue NON_SYSTEMATIC_ASSESSMENT Product Issues MedDRA 19.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Hallucination NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Chromaturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Reproductive system and breast disorders NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Idiopathic pulmonary fibrosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Upper respiratory tract congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Purpura NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Vena cava thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View