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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| D-serine (Glutamate Agonist) | 24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug. D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment. | None | None | 0 | 9 | 0 | 9 | View |
| Riluzole (Glutamate Antagonist) | 24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug. Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment. | None | None | 0 | 10 | 0 | 10 | View |
| Placebo | 12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug. Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules. | None | None | 0 | 5 | 0 | 5 | View |