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 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
NCT ID:
NCT05067335
Description:
SS - all randomized study participants who received at least 1 dose of IMP. As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romo arm (OL Period) and for a total of 12 months for participants in romo/romo arm (DB Period + OL Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during Overall Period. SS for OL period consisted of all randomized study participants who received at least 1 dose of IMP.
Frequency Threshold:
5
Time Frame:
From Baseline to Safety Follow Up (up to Month 15)
Study:
NCT05067335
Study Brief:
A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | Participants randomized to this arm received a matching placebo subcutaneously (sc) every month (QM) during the 6-month Double-blind (DB) Period. | 0 | None | 5 | 109 | 25 | 109 | View |
| Romosozumab | Participants randomized to this arm received romosozumab (Romo) 210 milligrams (mg) sc QM during the 6-month Double-blind Period. | 0 | None | 8 | 218 | 59 | 218 | View |
| Placebo/Romosozumab | After completion of the 6-month Double-blind Period, participants initially randomized to placebo arm switched to receive romosozumab 210 mg sc QM during the 6-month Open-label (OL) Period (up to Month 12). | 0 | None | 9 | 98 | 59 | 98 | View |
| Romosozumab/Romosozumab Overall | Participants who received romosozumab 210 mg sc QM during the 6-month Double-blind Period and continued to receive romosozumab 210 mg sc QM during the 6-month Open-label Period. | 1 | None | 25 | 218 | 155 | 218 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Uterine prolapse | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (v24.1) | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (v24.1) | View |
| Coronary artery disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (v24.1) | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (v24.1) | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (v24.1) | View |
| Bile duct stone | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (v24.1) | View |
| Cholangitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (v24.1) | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v24.1) | View |
| Spinal compression fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v24.1) | View |
| Ankle fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v24.1) | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v24.1) | View |
| Cervical polyp | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (v24.1) | View |
| Vaginal prolapse | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (v24.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (v24.1) | View |
| Arteriosclerosis coronary artery | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (v24.1) | View |
| Large intestine polyp | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v24.1) | View |
| Obstructive pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v24.1) | View |
| Granuloma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v24.1) | View |
| Cholecystitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (v24.1) | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v24.1) | View |
| Osteomyelitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v24.1) | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v24.1) | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v24.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v24.1) | View |
| Femoral neck fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v24.1) | View |
| Incisional hernia | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v24.1) | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v24.1) | View |
| Bone hypertrophy | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v24.1) | View |
| Adenocarcinoma gastric | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v24.1) | View |
| Meningioma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v24.1) | View |
| Cerebrovascular insufficiency | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v24.1) | View |
| Diabetic neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v24.1) | View |
| Lacunar infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v24.1) | View |
| Leukoencephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v24.1) | View |
| Vertebrobasilar insufficiency | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v24.1) | View |
| Calculus urinary | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (v24.1) | View |
| Renal cyst | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (v24.1) | View |
| Uterovaginal prolapse | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (v24.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v24.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v24.1) | View |
| Hyperlipidaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v24.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v24.1) | View |
| Suspected COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v24.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v24.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v24.1) | View |
| SARS-CoV-2 test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v24.1) | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v24.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v24.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v24.1) | View |