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:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
NCT ID:
NCT01963260
Description:
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
Frequency Threshold:
0
Time Frame:
Up to 84 days
Study:
NCT01963260
Study Brief:
Single Rising Dose Study of MK-8723 in Healthy Participants and Participants With Immune Thrombocytopenia Purpura (MK-8723-001)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part 1: MK-8723 10 mg/kg in Healthy Participants | MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1. | None | None | 0 | 6 | 4 | 6 | View |
| Part 1: MK-8723 30 mg/kg in Healthy Participants | MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1. | None | None | 0 | 6 | 1 | 6 | View |
| Part 1: MK-8723 100 mg/kg in Healthy Participants | MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1. | None | None | 0 | 6 | 4 | 6 | View |
| Part 1: Matching Placebo to MK-8723 | Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1. | None | None | 0 | 10 | 6 | 10 | View |
| Part 2: MK-8723 30 mg/kg in ITP Participants | MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2. | None | None | 0 | 2 | 2 | 2 | View |
| Part 2: MK-8723 100 mg/kg in ITP Participants | MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg. | None | None | 0 | 3 | 2 | 3 | View |
| Part 2: Matching Placebo to MK-8723 | Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2. | None | None | 0 | 4 | 2 | 4 | View |
| Part 1: MK-8723 3 mg/kg in Healthy Participants | MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1. | None | None | 0 | 6 | 2 | 6 | View |
| Part 2: MK-8723 10 mg/kg in ITP Participants | MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg. | None | None | 0 | 3 | 1 | 3 | View |
| Part 1: MK-8723 1 mg/kg in Healthy Participants | MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1. | None | None | 0 | 6 | 2 | 6 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 18.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 18.0 | View |
| Frequent bowel movements | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 18.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 18.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.0 | View |
| Feeling abnormal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.0 | View |
| Infectious mononucleosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 18.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 18.0 | View |
| Wrist fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 18.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 18.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 18.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | View |
| Myalgia intercostal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 18.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 18.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 18.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 18.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 18.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 18.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | View |
| Blood blister | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | View |
| Swelling face | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | View |