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 @ 2:23 PM
Ignite Modification Date:
2025-12-25 @ 12:59 PM
NCT ID:
NCT04664959
Description:
None
Frequency Threshold:
5
Time Frame:
Overall Period (18 months)
Study:
NCT04664959
Study Brief:
A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal 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 |
|---|---|---|---|---|---|---|---|---|
| SB16 | Subjects were randomly assigned to receive SB16 subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received SB16 in the Main period continued to receive SB16, but they also followed the randomisation procedure to maintain blinding. | 0 | None | 12 | 225 | 116 | 225 | View |
| Prolia Overall | Prolia Overall include subjects who had randomised to Prolia at Month 0 and had re-randomisation (Prolia+SB16 or Prolia+Prolia) at Month 12. Prolia+SB16 and Prolia+Prolia may not add up to Prolia Overall. | 0 | None | 11 | 231 | 107 | 231 | View |
| Prolia+SB16 | Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received Prolia in the Main period of the SB16-3001 study were randomised again in a 1:1 ratio to either continue on Prolia (Prolia+Prolia) or were transitioned to SB16 (Prolia+SB16). | 0 | None | 5 | 100 | 46 | 100 | View |
| Prolia+Prolia | Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received Prolia in the Main period of the SB16-3001 study were randomised again in a 1:1 ratio to either continue on Prolia (Prolia+Prolia) or were transitioned to SB16 (Prolia+SB16). | 0 | None | 3 | 101 | 49 | 101 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Adrenal adenoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Lung adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Forearm fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Subdural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Intracranial aneurysm | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Intestinal infarction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Urethral caruncle | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Spinal osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Intervertebral disc disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Intervertebral discitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |