Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:22 AM
Ignite Modification Date: 2025-12-26 @ 12:55 AM
NCT ID: NCT02094534
Description: Adverse Events of Hypoglycemia The CTCAE (version 4.0) definition for mild, moderate, and severe hypoglycemia based on blood glucose will be used, as shown below: Mild: from 55 to \<70 mg/dL Moderate: from 40 to \< 55 mg/dL Severe: from 30 to \< 40 mg/dL Life Threatening: \< 30 mg/dL (\< 1.7 mmol/L)
Frequency Threshold: 5
Time Frame: Three Months
Study: NCT02094534
Study Brief: A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ORMD-0801 API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801 ORMD-0801 capsules: API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules. 0 None 0 15 15 15 View
Placebo Fish oil in capsules, identical in appearance to ORMD-0801 0 None 0 10 10 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders (CTCAE) v.4.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders (CTCAE) v.4.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders (CTCAE) v.4.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders (CTCAE) v.4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders (CTCAE) v.4.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders (CTCAE) v.4.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders (CTCAE) v.4.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders (CTCAE) v.4.0 View
Head discomfort SYSTEMATIC_ASSESSMENT Nervous system disorders (CTCAE) v.4.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders (CTCAE) v.4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders (CTCAE) v.4.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders (CTCAE) v.4.0 View