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 @ 12:08 AM
Ignite Modification Date: 2025-12-25 @ 10:08 PM
NCT ID: NCT03711058
Description: Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements
Frequency Threshold: 5
Time Frame: Up to 51 months
Study: NCT03711058
Study Brief: Study of PI3Kinase Inhibition (Copanlisib) and Anti-PD-1 Antibody Nivolumab in Relapsed/Refractory Solid Tumors With Expansions in Mismatch-repair Proficient (MSS) Colorectal Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase II /Cohort B - PI3K Wild Type Copanlisib 60 mg will be administered as a 60-minute IV infusion (-5min/+10min) on Day 1, 8, and 15 of each 28-day cycle. Nivolumab 480 mg will be administered as a 30-minute IV infusion (-5min/+10min) on Day 1 of each 28-day cycle. 9 None 6 12 12 12 View
Phase I - Dose Finding (Dose Level 1) Copanlisib will be administered as a 60-minute IV infusion (-5min/+10min) at Dose Level 1: 60mg on Day 1, 8, and 15 of each 28-day cycle. Nivolumab 480 mg will be administered as a 30-minute IV infusion (-5min/+10min) on Day 1 of each 28-day cycle. 6 None 3 6 6 6 View
Phase II /Cohort A - PI3K Mutation Copanlisib 60 mg will be administered as a 60-minute IV infusion (-5min/+10min) on Day 1, 8, and 15 of each 28-day cycle. Nivolumab 480 mg will be administered as a 30-minute IV infusion (-5min/+10min) on Day 1 of each 28-day cycle. 14 None 11 21 21 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Chylothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chylous ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colonic perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Disease progression SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash maculopapular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Oral Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vocal Cord Paralysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Benign nodule SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal inflammation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Palmar-plantar erythrodysesthesia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculopapular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Blood Lactate Dehydrogenase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Toe Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nail Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Groin Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophageal varices SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lip pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ALT increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
AST increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations None View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Serum amylase increased SYSTEMATIC_ASSESSMENT Investigations None View
TSH increased SYSTEMATIC_ASSESSMENT Investigations None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Belching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lower gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Obstruction gastric SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper gastrointestinal hemorrage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain at biopsy site SYSTEMATIC_ASSESSMENT General disorders None View
Portal hypertension SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enterocolitis infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis infective SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Shingles SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Thrush SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Swollen lymph node SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View