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 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
NCT ID:
NCT04154956
Description:
Analysis was performed on safety population. All-cause mortality data was collected on randomized population.
Frequency Threshold:
5
Time Frame:
TEAEs were collected from date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks. All-cause mortality data was collected from date of first study treatment administration (Day 1) until the primary analysis date of 22 September 2023 (up to 189 weeks).
Study:
NCT04154956
Study Brief:
SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung 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 |
|---|---|---|---|---|---|---|---|---|
| Tusamitamab Ravtansine | Participants received tusamitamab ravtansine 100 mg/m\^2 by IV infusion, once Q2W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks). | 109 | None | 55 | 194 | 159 | 194 | View |
| Docetaxel | Participants received docetaxel 75 mg/m\^2 by IV infusion, once Q3W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 115 weeks). | 110 | None | 68 | 177 | 151 | 177 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina Pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 26.0 | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 26.0 | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 26.0 | View |
| Vertigo Positional | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDra 26.0 | View |
| Dry Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.0 | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.0 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Cholestasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 26.0 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Accidental Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.0 | View |
| Compression Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.0 | View |
| Rib Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.0 | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.0 | View |
| Agranulocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.0 | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.0 | View |
| Myelosuppression | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.0 | View |
| Colitis Ischaemic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Colitis Ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Gastric Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Gastrointestinal Inflammation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Mechanical Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Obstruction Gastric | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Oesophageal Stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.0 | View |
| Disease Progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.0 | View |
| Non-Cardiac Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.0 | View |
| Sudden Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.0 | View |
| Cholecystitis Acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 26.0 | View |
| Hepatic Failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 26.0 | View |
| Abdominal Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Abdominal Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Atypical Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Covid-19 Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Clostridium Difficile Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Gastrointestinal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Infectious Pleural Effusion | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Neutropenic Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Pneumocystis Jirovecii Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Pneumonia Influenzal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Blood Creatinine Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.0 | View |
| Neutrophil Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.0 | View |
| Oxygen Saturation Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.0 | View |
| Platelet Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.0 | View |
| Transaminases Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.0 | View |
| Troponin T Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.0 | View |
| White Blood Cell Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.0 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 26.0 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 26.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 26.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.0 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.0 | View |
| Bone Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.0 | View |
| Intervertebral Disc Protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.0 | View |
| Pathological Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.0 | View |
| Spinal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.0 | View |
| Intracranial Tumour Haemorrhage | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 26.0 | View |
| Malignant Pleural Effusion | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 26.0 | View |
| Pericardial Effusion Malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 26.0 | View |
| Tumour Associated Fever | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 26.0 | View |
| Brain Oedema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Cerebrovascular Accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Generalised Tonic-Clonic Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Intracranial Pressure Increased | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Malignant Spinal Cord Compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 26.0 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 26.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 26.0 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 26.0 | View |
| Acute Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Haemothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Interstitial Lung Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Pneumothorax Spontaneous | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Productive Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Pulmonary Haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Pulmonary Oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 26.0 | View |
| Peripheral Artery Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.0 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 26.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 26.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Neuropathy Peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Peripheral Sensory Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.0 | View |
| Dry Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.0 | View |
| Keratitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.0 | View |
| Keratopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.0 | View |
| Lacrimation Increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.0 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.0 | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.0 | View |
| Neutrophil Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.0 | View |