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: 2025-12-26 @ 10:58 AM
Ignite Modification Date: 2025-12-26 @ 10:58 AM
NCT ID: NCT00931606
Description: The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Frequency Threshold: 5
Time Frame: Up to Day 281
Study: NCT00931606
Study Brief: Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sotatercept 0.1 mg/kg Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses. 1 None 0 8 6 8 View
Sotatercept 0.3 mg/kg Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses. 3 None 2 10 7 10 View
Sotatercept 0.5 mg/kg Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses. 3 None 3 7 7 7 View
Placebo Participants received placebo subcutaneously every 28 days up to 4 doses. 0 None 1 5 5 5 View
Total Total for all participants 7 None 6 30 25 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Gastric ulcer perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Peptic ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Breast cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Nodal arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Aphthous stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Oral discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Peritoneal effusion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Pneumoperitoneum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Local swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.1 View
Clostridial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Helicobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Device migration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Prothrombin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Skin turgor decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Staphylococcal identification test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Urine output decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Vitamin D decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Muscle haemorrhage SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Metastases to gastrointestinal tract SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
Metastases to lymph nodes SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
Tumour haemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Unresponsive to stimuli SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Enuresis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Polyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Breast mass SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.1 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.1 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View