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 @ 10:33 PM
Ignite Modification Date: 2025-12-25 @ 8:05 PM
NCT ID: NCT05008835
Description: None
Frequency Threshold: 5
Time Frame: AEs were planned to be reported from signing informed consent to the end of the follow-up period. Since the study was prematurely terminated, the AE reporting period was abbreviated and thus, AEs were assessed from signing the informed consent to the end of treatment, the mean (SD) duration of this period was 24.1 (8.2) days.
Study: NCT05008835
Study Brief: Evaluate the Efficacy and Safety of ACP-044 in Subjects With Pain Associated With Osteoarthritis of the Knee
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Administration of ACP-044 matching placebo 4 times daily (morning, noon, evening, night) 0 None 0 21 0 21 View
ACP-044 400 mg QID Administration 4 times daily (morning, noon, evening, night) of 400 mg ACP-044 At each the morning and evening administration, patients received one placebo tablet and one tablet containing ACP-044 400 mg. At each the noon and night administration, patients received one tablet containing ACP-044 400 mg. 0 None 0 20 4 20 View
ACP-044 800 mg BID Administration 2 times daily (morning, noon, evening, night) of 800 mg ACP-044 At each the morning and evening administration, patients received 2 tablets containing ACP-044 400 mg. At each the noon and night administration, patients received one placebo tablet. 0 None 0 20 4 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Ligament sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Cervical radiculopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View