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: 2025-12-25 @ 2:09 AM
Ignite Modification Date: 2025-12-26 @ 12:36 AM
NCT ID: NCT03035760
Description: None
Frequency Threshold: 0
Time Frame: AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
Study: NCT03035760
Study Brief: Multiple Ascending Dose Study of Oxfendazole in Healthy Adult Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 2: 7.5 mg/kg Oxfendazole for 5 Days Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days 0 None 0 8 3 8 View
Arm 3: 15 mg/kg Oxfendazole for 5 Days Participants received 15 mg/kg oxfendazole orally once daily for 5 days 0 None 0 8 2 8 View
Arm 4: 3 mg/kg Oxfendazole, Post Fast 3 mg/kg oxfendazole orally, one dose received following a fast on Day 1 or on Day 8 0 None 0 12 1 12 View
Arm 4: 3 mg/kg Oxfendazole, Post Fed 3 mg/kg oxfendazole orally, one dose received following a high fat meal on Day 1 or on Day 8 0 None 0 12 3 12 View
Arm 1: 3 mg/kg Oxfendazole for 5 Days Participants received 3 mg/kg oxfendazole orally once daily for 5 days 0 None 0 8 3 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vessel Puncture Site Haemorrhage NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Oropharyngial Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Electrocardiogram QT Prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Decreased Appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View