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 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
NCT ID:
NCT01908751
Description:
An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following:
* Fatal
* Life threatening
* Requires or prolongs hospital stay
* Results in persistent or significant disability or incapacity
* A congenital anomaly or birth defect
* An important medical event
Frequency Threshold:
0
Time Frame:
12 months
Study:
NCT01908751
Study Brief:
Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Sliding Hip Screw + Vitamin D Supplementation | Participants allocated to this group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate and were given a six-month supply of vitamin D3 supplementation. Participants in the vitamin D Group received a bottle of 2,000 International Units (IU) vitamin D3 drops (Ddrops®, Ddrops Company). Participants were instructed to take two drops daily for six months, for a total daily dose of 4,000 IU. | 0 | None | 5 | 22 | 2 | 22 | View |
| Cancellous Screws + Vitamin D Supplementation | Participants allocated to this group received multiple cancellous screws with a minimum diameter of 6.5 mm and were given a six-month supply of vitamin D3 supplementation. Participants in the vitamin D Group received a bottle of 2,000 International Units (IU) vitamin D3 drops (Ddrops®, Ddrops Company). Participants were instructed to take two drops daily for six months, for a total daily dose of 4,000 IU. | 0 | None | 6 | 23 | 3 | 23 | View |
| Sliding Hip Screw + Vitamin D Placebo | Participants allocated to this group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate and were given an identical bottle of placebo drops with no active ingredient. Similarly, they were instructed to take two drops daily for six months. The placebo supplement was also manufactured by the Ddrops Company. | 0 | None | 9 | 21 | 3 | 21 | View |
| Cancellous Screws + Vitamin D Placebo | Participants allocated to this group received multiple cancellous screws with a minimum diameter of 6.5 mm and were given an identical bottle of placebo drops with no active ingredient. Similarly, they were instructed to take two drops daily for six months. The placebo supplement was also manufactured by the Ddrops Company. | 0 | None | 5 | 20 | 3 | 20 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Aortic valve replacement due to intravalvular prosthetic regurgitation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Painful Hardware or Hardware Failure/Breakage | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Nonunion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Osteonecrosis, symptomatic | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Post-traumatic femoral acetabular impingement & hip range of motion restrictions | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Infection (deep) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Delayed Union | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Osteonecrosis, asymptomatic | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Accident/Fall | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Rash/Skin Irritation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Meniscal tear | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |