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 @ 5:06 PM
Ignite Modification Date:
2025-12-25 @ 2:44 PM
NCT ID:
NCT04823650
Description:
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
Frequency Threshold:
5
Time Frame:
From Day 1 to Day 15 (+3 days)
Study:
NCT04823650
Study Brief:
Monitoring Activity And Gait In Children
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1. | 0 | None | 0 | 13 | 4 | 13 | View |
| Cohort A: Participants Aged 6-11 Years | Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1. | 0 | None | 0 | 14 | 3 | 14 | View |
| Cohort A: Participants Aged 12-17 Years | Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1. | 0 | None | 0 | 13 | 3 | 13 | View |
| Cohort B: Participants Aged 3-5 Years | Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1. | 0 | None | 0 | 13 | 2 | 13 | View |
| Cohort B: Participants Aged 6-11 Years | Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1. | 0 | None | 0 | 17 | 4 | 17 | View |
| Cohort B: Participants Aged 12-17 Years | Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1. | 0 | None | 0 | 17 | 3 | 17 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Medical device site bruise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.1 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.1 | View |
| Skin indentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.1 | View |
| Medical device site irritation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.1 | View |
| Medical device site rash | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.1 | View |
| Joint injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.1 | View |
| Respiratory disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | View |