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 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
NCT ID:
NCT03728634
Description:
Safety Set included all randomized participants who received at least 1 injection of study drug (ION-682884 or placebo).
Frequency Threshold:
0
Time Frame:
Up to Day 176
Study:
NCT03728634
Study Brief:
Evaluate the Safety and Tolerability, as Well as the Pharmacokinetic and Pharmacodynamic Profiles of Single and Multiple Doses of Eplontersen Administered Subcutaneously to Healthy Volunteers and Patients With Hereditary Transthyretin-Mediated Amyloidosis (hATTR ).
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Multiple Dose Cohort: Placebo | Participants received ION-682884 matching placebo, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period. | 0 | None | 0 | 6 | 3 | 6 | View |
| Multiple Dose Cohort A: ION-682884 45 mg | Participants received ION-682884, 45 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period. | 0 | None | 0 | 10 | 1 | 10 | View |
| Multiple Dose Cohort E: ION-682884 60 mg | Participants received ION-682884, 60 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period. | 0 | None | 0 | 10 | 3 | 10 | View |
| Single Dose Cohort C: ION-682884 120 mg | Participants received single dose of ION-682884,120 mg, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1. | 0 | None | 0 | 9 | 4 | 9 | View |
| Multiple Dose Cohort B: ION-682884 90 mg | Participants received ION-682884, 90 mg, SC, Q4W (total of 4 doses) along with daily oral supplemental doses of the RDA of vitamin A during the 13-week Treatment Period. | 0 | None | 0 | 10 | 7 | 10 | View |
| Single Dose Cohort: Placebo | Participants received single dose of ION-682884 matching placebo, SC along with daily oral supplemental doses of the RDA of vitamin A on Day 1. | 0 | None | 0 | 2 | 1 | 2 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (21.1) | View |
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Vessel puncture site bruise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Vessel puncture site paraesthesia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.1) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.1) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.1) | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.1) | View |
| Limb discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | View |