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 @ 5:55 PM
Ignite Modification Date:
2025-12-25 @ 3:19 PM
NCT ID:
NCT02907268
Description:
None
Frequency Threshold:
0
Time Frame:
4 months (September 2013-January 2015)
Study:
NCT02907268
Study Brief:
Botulinum Toxin A Single Blind Split-Face Randomized Pilot Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment Arm A | The first treatment group received onabotulinumtoxinA (Botox) on the right side of their face and abobotulinumtoxinA (Dysport) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. onabotulinumtoxinA: OnabotulinumtoxinA was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead. abobotulinumtoxinA: AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead. | 0 | None | 0 | 5 | 3 | 5 | View |
| Treatment Arm B | The second treatment group received abobotulinumtoxinA (Dysport) on the right side of their face and onabotulinumtoxinA (Botox) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. onabotulinumtoxinA: OnabotulinumtoxinA was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead. abobotulinumtoxinA: AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead. | 0 | None | 0 | 5 | 5 | 5 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bruise | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Drooping | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Face flushed | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pain during injection | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Acne breakout | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Welt on forehead | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Stinging sensation on face | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Itchiness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Left cheek looks more full | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Tension headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Worsening inflammation at sacroiliac joint | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Cold | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Numbness on forehead | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |