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 @ 3:07 PM
Ignite Modification Date:
2025-12-25 @ 1:28 PM
NCT ID:
NCT00529659
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00529659
Study Brief:
A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| MK-0773 | MK-0773 was administered orally twice daily (BID) at a dose of 50 mg. | None | None | 12 | 81 | 50 | 81 | View |
| Placebo | Placebo administered orally twice daily. | None | None | 9 | 89 | 52 | 89 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute myocardial infarction | None | Cardiac disorders | MedDRA (10.0) | View |
| Aortic valve stenosis | None | Cardiac disorders | MedDRA (10.0) | View |
| Cardiac failure | None | Cardiac disorders | MedDRA (10.0) | View |
| Cardiac failure congestive | None | Cardiac disorders | MedDRA (10.0) | View |
| Myocardial infarction | None | Cardiac disorders | MedDRA (10.0) | View |
| Supraventricular tachycardia | None | Cardiac disorders | MedDRA (10.0) | View |
| Abdominal distention | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Abdominal pain upper | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Constipation | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Pancreatic mass | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Death | None | General disorders | MedDRA (10.0) | View |
| Lower respiratory tract infection | None | Infections and infestations | MedDRA (10.0) | View |
| Humerus fracture | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Lower limb fracture | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Medical device complication | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Alanine aminotransferase increased | None | Investigations | MedDRA (10.0) | View |
| Aspartate aminotransferase increased | None | Investigations | MedDRA (10.0) | View |
| Transaminases increased | None | Investigations | MedDRA (10.0) | View |
| Breast cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | View |
| Oesophageal carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | View |
| Ischaemic stroke | None | Nervous system disorders | MedDRA (10.0) | View |
| Transient ischaemic attack | None | Nervous system disorders | MedDRA (10.0) | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Deep vein thrombosis | None | Vascular disorders | MedDRA (10.0) | View |
| Hypertension | None | Vascular disorders | MedDRA (10.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Normochromic normocytic anaemia | None | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Acute myocardial infarction | None | Cardiac disorders | MedDRA (10.0) | View |
| Aortic valve stenosis | None | Cardiac disorders | MedDRA (10.0) | View |
| Atrial fibrillation | None | Cardiac disorders | MedDRA (10.0) | View |
| Cardiac failure | None | Cardiac disorders | MedDRA (10.0) | View |
| Cardiac failure congestive | None | Cardiac disorders | MedDRA (10.0) | View |
| Hypertensive cardiomyopathy | None | Cardiac disorders | MedDRA (10.0) | View |
| Myocardial infarction | None | Cardiac disorders | MedDRA (10.0) | View |
| Palpitations | None | Cardiac disorders | MedDRA (10.0) | View |
| Subendocardial ischaemia | None | Cardiac disorders | MedDRA (10.0) | View |
| Supraventricular extrasystoles | None | Cardiac disorders | MedDRA (10.0) | View |
| Supraventricular tachycardia | None | Cardiac disorders | MedDRA (10.0) | View |
| Inner ear disorder | None | Ear and labyrinth disorders | MedDRA (10.0) | View |
| Addison's disease | None | Endocrine disorders | MedDRA (10.0) | View |
| Hypopituitarism | None | Endocrine disorders | MedDRA (10.0) | View |
| Hypothyroidism | None | Endocrine disorders | MedDRA (10.0) | View |
| Cataract | None | Eye disorders | MedDRA (10.0) | View |
| Conjunctivitis | None | Eye disorders | MedDRA (10.0) | View |
| Abdominal distension | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Abdominal pain | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Abdominal pain upper | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Anorectal discomfort | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Colitis | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Constipation | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Dental caries | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Dyspepsia | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Flatulence | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Food poisoning | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Gastritis | None | General disorders | MedDRA (10.0) | View |
| Gastrooesophageal reflux disease | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Irritable bowel syndrome | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Nausea | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Pancreatic mass | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Toothache | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Asthenia | None | General disorders | MedDRA (10.0) | View |
| Death | None | General disorders | MedDRA (10.0) | View |
| Discomfort | None | General disorders | MedDRA (10.0) | View |
| Face oedema | None | General disorders | MedDRA (10.0) | View |
| Fatigue | None | General disorders | MedDRA (10.0) | View |
| Gait disturbance | None | General disorders | MedDRA (10.0) | View |
| Influenza like illness | None | General disorders | MedDRA (10.0) | View |
| Malaise | None | General disorders | MedDRA (10.0) | View |
| Oedema peripheral | None | General disorders | MedDRA (10.0) | View |
| Pyrexia | None | General disorders | MedDRA (10.0) | View |
| Hypersensitivity | None | Immune system disorders | MedDRA (10.0) | View |
| Bronchitis | None | Infections and infestations | MedDRA (10.0) | View |
| Bronchopneumonia | None | Infections and infestations | MedDRA (10.0) | View |
| Cellulitis | None | Infections and infestations | MedDRA (10.0) | View |
| Folliculitis | None | Infections and infestations | MedDRA (10.0) | View |
| Gastroenteritis | None | Infections and infestations | MedDRA (10.0) | View |
| Gastroenteritis viral | None | Infections and infestations | MedDRA (10.0) | View |
| Herpes zoster | None | Infections and infestations | MedDRA (10.0) | View |
| Influenza | None | Infections and infestations | MedDRA (10.0) | View |
| Localised infection | None | Infections and infestations | MedDRA (10.0) | View |
| Lower respiratory tract infection | None | Infections and infestations | MedDRA (10.0) | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA (10.0) | View |
| Oral herpes | None | Infections and infestations | MedDRA (10.0) | View |
| Pneumonia | None | Infections and infestations | MedDRA (10.0) | View |
| Tooth abscess | None | Infections and infestations | MedDRA (10.0) | View |
| Upper respiratory tract infection | None | Infections and infestations | MedDRA (10.0) | View |
| Urinary tract infection | None | Infections and infestations | MedDRA (10.0) | View |
| Contusion | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Fall | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Forearm fracture | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Head injury | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Humerus fracture | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Joint dislocation | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Joint injury | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Joint sprain | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Limb injury | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Lower limb fracture | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Medical device complication | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Pelvic fracture | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Radius fracture | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Ulna fracture | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Upper limb fracture | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Alanine aminotransferase increased | None | Investigations | MedDRA (10.0) | View |
| Aspartate aminotransferase increased | None | Investigations | MedDRA (10.0) | View |
| Blood cortisol decreased | None | Investigations | MedDRA (10.0) | View |
| Blood sodium decreased | None | Investigations | MedDRA (10.0) | View |
| Electrocardiogram T wave inversion | None | Investigations | MedDRA (10.0) | View |
| Haematocrit decreased | None | Investigations | MedDRA (10.0) | View |
| Haematocrit increased | None | Investigations | MedDRA (10.0) | View |
| Haemoglobin decreased | None | Investigations | MedDRA (10.0) | View |
| Haemoglobin increased | None | Investigations | MedDRA (10.0) | View |
| High density lipoprotein decreased | None | Investigations | MedDRA (10.0) | View |
| Neutrophil count increased | None | Investigations | MedDRA (10.0) | View |
| Platelet count increased | None | Investigations | MedDRA (10.0) | View |
| Transaminases increased | None | Investigations | MedDRA (10.0) | View |
| Weight increased | None | Investigations | MedDRA (10.0) | View |
| White blood cell count increased | None | Investigations | MedDRA (10.0) | View |
| Decreased appetite | None | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Hypoglycaemia | None | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Increased appetite | None | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Bone pain | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Bursitis | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Costochondritis | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Fibromyalgia | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Joint swelling | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Muscle spasms | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Musculoskeletal pain | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Musculoskeletal stiffness | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Neck pain | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Osteoarthritis | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Osteopenia | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Breast cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | View |
| Oesophageal carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | View |
| Oesophageal carcinoma | None | Nervous system disorders | MedDRA (10.0) | View |
| Dysstasia | None | Nervous system disorders | MedDRA (10.0) | View |
| Essential tremor | None | Nervous system disorders | MedDRA (10.0) | View |
| Headache | None | Nervous system disorders | MedDRA (10.0) | View |
| Ischaemic stroke | None | Nervous system disorders | MedDRA (10.0) | View |
| Lethargy | None | Nervous system disorders | MedDRA (10.0) | View |
| Paraesthesia | None | Nervous system disorders | MedDRA (10.0) | View |
| Sciatica | None | Nervous system disorders | MedDRA (10.0) | View |
| Transient ischaemic attack | None | Nervous system disorders | MedDRA (10.0) | View |
| Depression | None | Psychiatric disorders | MedDRA (10.0) | View |
| Insomnia | None | Psychiatric disorders | MedDRA (10.0) | View |
| Breast cyst | None | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Acne | None | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Alopecia | None | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Rash macular | None | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Deep vein thrombosis | None | Vascular disorders | MedDRA (10.0) | View |
| Haematoma | None | Vascular disorders | MedDRA (10.0) | View |
| Hypertension | None | Vascular disorders | MedDRA (10.0) | View |
| Hypotension | None | Vascular disorders | MedDRA (10.0) | View |
| Varicose ulceration | None | Vascular disorders | MedDRA (10.0) | View |