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:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
NCT ID:
NCT00091793
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00091793
Study Brief:
Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Incisional hernia, obstructive | None | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Patella fracture | None | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Tibia fracture | None | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Breast cancer in situ | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | View |
| Mycosis fungoides | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | View |
| Ovarian cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | View |
| Uterine cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | View |
| Facial palsy | None | Nervous system disorders | MedDRA 9.0 | View |
| Depression | None | Psychiatric disorders | MedDRA 9.0 | View |
| Pelvic prolapse | None | Reproductive system and breast disorders | MedDRA 9.0 | View |
| Uterine perforation | None | Reproductive system and breast disorders | MedDRA 9.0 | View |
| Colitis ischaemic | None | Gastrointestinal disorders | MedDRA 9.0 | View |
| Colonic polyp | None | Gastrointestinal disorders | MedDRA 9.0 | View |
| Cholelithiasis | None | Hepatobiliary disorders | MedDRA 9.0 | View |
| Appendicitis | None | Infections and infestations | MedDRA 9.0 | View |
| Cellulitis | None | Infections and infestations | MedDRA 9.0 | View |
| Diverticulitis | None | Infections and infestations | MedDRA 9.0 | View |
| Lobar pneumonia | None | Infections and infestations | MedDRA 9.0 | View |
| Pneumonia | None | Infections and infestations | MedDRA 9.0 | View |
| Pyelonephritis | None | Infections and infestations | MedDRA 9.0 | View |
| Sepsis | 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 |
| Intervertebral disc protrusion | None | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Osteoarthritis | None | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| B-cell lymphoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | None | Gastrointestinal disorders | MedDRA 9.0 | View |
| Constipation | None | Gastrointestinal disorders | MedDRA 9.0 | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA 9.0 | View |
| Dyspepsia | 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 |
| Fatigue | None | General disorders | MedDRA 9.0 | View |
| Influenza | None | Infections and infestations | MedDRA 9.0 | View |
| Nasopharyngitis | 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 |
| Procedural pain | None | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Muscle spasms | 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 |
| Dizziness | None | Nervous system disorders | MedDRA 9.0 | View |
| Headache | None | Nervous system disorders | MedDRA 9.0 | View |
| Hypoaesthesia | None | Nervous system disorders | MedDRA 9.0 | View |
| Depression | None | Psychiatric disorders | MedDRA 9.0 | View |
| Insomnia | None | Psychiatric disorders | MedDRA 9.0 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Pharyngolaryngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA 9.0 | View |
| Hypertension | None | Vascular disorders | MedDRA 9.0 | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |