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 @ 12:51 PM
Ignite Modification Date:
2025-12-25 @ 12:15 PM
NCT ID:
NCT00089661
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00089661
Study Brief:
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute myocardial infarction | None | Cardiac disorders | MedDRA 9.0 | View |
| Atrial fibrillation | None | Cardiac disorders | MedDRA 9.0 | View |
| Atrioventricular block second degree | None | Cardiac disorders | MedDRA 9.0 | View |
| Cardiac failure congestive | None | Cardiac disorders | MedDRA 9.0 | View |
| Myocardial infarction | None | Cardiac disorders | MedDRA 9.0 | View |
| Myocardial ischaemia | None | Cardiac disorders | MedDRA 9.0 | View |
| Goitre | None | Endocrine disorders | MedDRA 9.0 | View |
| Colitis ischaemic | None | Gastrointestinal disorders | MedDRA 9.0 | View |
| Diverticulum | None | Gastrointestinal disorders | MedDRA 9.0 | View |
| Faecaloma | None | Gastrointestinal disorders | MedDRA 9.0 | View |
| Gastrointestinal haemorrhage | None | Gastrointestinal disorders | MedDRA 9.0 | View |
| Large intestine perforation | None | Gastrointestinal disorders | MedDRA 9.0 | View |
| Small intestinal obstruction | None | Gastrointestinal disorders | MedDRA 9.0 | View |
| Pelvic mass | None | General disorders | MedDRA 9.0 | View |
| Cholecystitis | None | Hepatobiliary disorders | MedDRA 9.0 | View |
| Cholelithiasis | None | Hepatobiliary disorders | MedDRA 9.0 | View |
| Cellulitis | None | Infections and infestations | MedDRA 9.0 | View |
| Diverticulitis | None | Infections and infestations | MedDRA 9.0 | View |
| Labyrinthitis | None | Infections and infestations | MedDRA 9.0 | View |
| Pneumonia | None | Infections and infestations | MedDRA 9.0 | View |
| Femoral neck fracture | None | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Fracture | None | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Incisional hernia | None | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Arthritis | None | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Intervertebral disc protrusion | None | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Osteoarthritis | None | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Benign breast neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | View |
| Benign ovarian tumour | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | View |
| Breast cancer in situ | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | View |
| Breast cancer metastatic | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | View |
| Colon adenoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | View |
| Malignant pleural effusion | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | View |
| Metastases to bone | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | View |
| Metastases to liver | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | View |
| Metastatic neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | View |
| Uterine leiomyoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | View |
| Transient ischaemic attack | None | Nervous system disorders | MedDRA 9.0 | View |
| Rectocele | None | Reproductive system and breast disorders | MedDRA 9.0 | View |
| Chronic obstructive pulmonary disease | None | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Pneumonitis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Respiratory failure | None | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | None | Gastrointestinal disorders | MedDRA 9.0 | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA 9.0 | View |
| Gastrooesophageal reflux disease | None | Gastrointestinal disorders | MedDRA 9.0 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA 9.0 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 9.0 | View |
| Fatigue | None | General disorders | MedDRA 9.0 | View |
| Oedema peripheral | None | General disorders | MedDRA 9.0 | View |
| Bronchitis | None | Infections and infestations | MedDRA 9.0 | View |
| Sinusitis | None | Infections and infestations | MedDRA 9.0 | View |
| Upper respiratory tract infection | None | Infections and infestations | MedDRA 9.0 | View |
| Urinary tract infection | None | Infections and infestations | MedDRA 9.0 | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Arthritis | None | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Bone pain | None | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Muscle spasms | None | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Musculoskeletal chest pain | None | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Shoulder pain | None | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Headache | None | Nervous system disorders | MedDRA 9.0 | View |
| Hypoaesthesia | None | Nervous system disorders | MedDRA 9.0 | View |
| Anxiety | None | Psychiatric disorders | MedDRA 9.0 | View |
| Depression | None | Psychiatric disorders | MedDRA 9.0 | View |
| Insomnia | None | Psychiatric disorders | MedDRA 9.0 | View |
| Breast pain | None | Reproductive system and breast disorders | MedDRA 9.0 | View |
| Vulvovaginal dryness | None | Reproductive system and breast disorders | MedDRA 9.0 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA 9.0 | View |
| Hot flush | None | Vascular disorders | MedDRA 9.0 | View |
| Hypertension | None | Vascular disorders | MedDRA 9.0 | View |