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 @ 7:47 PM
Ignite Modification Date: 2025-12-25 @ 5:24 PM
NCT ID: NCT04659603
Description: Analysis was performed on all-treated population.
Frequency Threshold: 5
Time Frame: From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 86.6 weeks.
Study: NCT04659603
Study Brief: Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort A: mBC Participants with mBC received an IV infusion of tusamitamab ravtansine at a loading dose of 170 mg/m\^2 on Day 1 of Cycle 1 (cycle duration: 2 weeks), followed by 100 mg/m\^2 Q2W from Cycle 2 until documented disease progression, unacceptable toxicity, new anticancer therapy initiation, or the participant's or Investigator's decision to stop the treatment. 4 None 0 6 6 6 View
Cohort B: mPAC Participants with mPAC received an IV infusion of tusamitamab ravtansine at a loading dose of 170 mg/m\^2 on Day 1 of Cycle 1 (cycle duration: 2 weeks), followed by 100 mg/m\^2 Q2W from Cycle 2 until documented disease progression, unacceptable toxicity, new anticancer therapy initiation, or the participant's or Investigator's decision to stop the treatment. 21 None 16 28 23 28 View
Cohort C: mPAC Participants with mPAC received an IV infusion of tusamitamab ravtansine at an initial loading dose of 170 mg/m\^2 on Day 1, followed by 100 mg/m\^2 Q2W along with gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15 Q4W until documented disease progression, unacceptable toxicity, new anticancer therapy initiation, or the participant's or Investigator's decision to stop the treatment. 9 None 9 16 14 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Biliary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Device Related Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Diarrhoea Infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.1 View
Ischaemic Cerebral Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Duodenal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Duodenal Stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Gastric Dilatation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Gastritis Erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Intestinal Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Small Intestinal Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Biliary Obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.1 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.1 View
Cholangitis Acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.1 View
Jaundice Cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.1 View
Complication Associated With Device SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Radiation Osteitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Candida Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Tumour Pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 27.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.1 View
Myelosuppression SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.1 View
Contrast Media Allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDra 27.1 View
Contrast Media Reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDra 27.1 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.1 View
Iron Deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.1 View
Vitamin D Deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.1 View
Anxiety Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.1 View
Sleep Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View
Neuropathy Peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Gastrointestinal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Dermatitis Allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Night Sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Intervertebral Disc Protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.1 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.1 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 27.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Blood Bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Electrocardiogram Qt Prolonged SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Hepatic Enzyme Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Platelet Count Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Transaminases Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View
Diabetic Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDra 27.1 View
Dry Eye SYSTEMATIC_ASSESSMENT Eye disorders MedDra 27.1 View
Eye Pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDra 27.1 View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDra 27.1 View
Keratopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDra 27.1 View
Vision Blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDra 27.1 View
Xerophthalmia SYSTEMATIC_ASSESSMENT Eye disorders MedDra 27.1 View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Dyspnoea Exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Rash Maculo-Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Skin Reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.1 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.1 View