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 @ 5:39 PM
Ignite Modification Date: 2025-12-25 @ 3:09 PM
NCT ID: NCT01108068
Description: Two of the participants in the lithium trial also have a severe autistic phenotype. We had hoped that the Lithium might improve their behavior. However, in one of theses 2 participants, his behavior worsened (confirmed by the Vanderbilt standardized behavioral questionnaire and he had to drop out of the study. After stopping Lithium, his behavior promptly returned to his baseline.
Frequency Threshold: 5
Time Frame: 6 months, during the administration of lithium to 5 participants
Study: NCT01108068
Study Brief: Trial of Lithium Carbonate for Treatment of Osteoporosis-pseudoglioma Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lithium patients with OPPG will be treated with lithium for 6 months Lithium: lithium will be given for 6 months to patients with OPPG, starting at a low dose of 2.5 mg/kg daily, gradually increasing until a lithium blood level of 0.3-0.6 ng/dl is achieved. 0 None 0 10 1 10 View
Unaffected Controls Family members of patients with OPPG will have DXA and pQCT to compare to OPPG patients. These unaffected participants will not receive lithium. 0 None 0 16 0 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
elevated liver function test SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View