Adverse Events Module

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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 @ 5:34 PM
Ignite Modification Date: 2025-12-25 @ 3:06 PM
NCT ID: NCT05039268
Description: Adverse events are continuously collected from day-of-consent through end-of-participation for each participant.
Frequency Threshold: 0
Time Frame: Day-of-consent through end-of-participation, 15 days
Study: NCT05039268
Study Brief: 3K3A-APC for Treatment of Amyotrophic Lateral Sclerosis (ALS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
15mg Dose Group Participants will receive a fixed dose regimen of five doses of 15mg. 3K3A-APC Protein: 3K3A-APC with intravenous dosing of five doses of either 15mg or 30mg at 12 hourly interval. The first 8 patients will receive 15mg dose, and the next 8 patients will receive 30mg dose. 0 None 0 8 4 8 View
30mg Dose Group Participants will receive a fixed dose regimen of five doses of 30mg. 3K3A-APC Protein: 3K3A-APC with intravenous dosing of five doses of either 15mg or 30mg at 12 hourly interval. The first 8 patients will receive 15mg dose, and the next 8 patients will receive 30mg dose. 0 None 0 8 6 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Neutrophilia SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Blood calcium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Blood bicarbonate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Supraventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Herpes virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Catheter site extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View