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 @ 7:11 PM
Ignite Modification Date:
2025-12-25 @ 4:45 PM
NCT ID:
NCT00251303
Description:
None
Frequency Threshold:
5
Time Frame:
12 weeks double-blind period.
Study:
NCT00251303
Study Brief:
Riluzole to Treat Child and Adolescent Obsessive-Compulsive Disorder With or Without Autism Spectrum Disorders
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Riluzole | In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts. Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent. | None | None | 1 | 30 | 27 | 30 | View |
| Placebo | Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily. Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study. | None | None | 0 | 30 | 29 | 30 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| nasal congestion, bloody nose, sore throat, difficulty swallowing, and flu upper respitory | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| nose throat other, shortness of breath, wheezing, and coughing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| medical or surgical procedure | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| tiredness fatigue, increased/decreased motor activity, difficulty falling asleep | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| early morning awakening, interrupted sleep, drowsiness sedation, hallucinations, depression, anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| irritability, suicidal ideas, suicidal behavior, agression, and psychological behavior other | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Dermatologic Skin Irritation, Sweating, hair problems, and skin other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| breast pain swelling, discharge from nipples, menstrual irregularity, cramps, premenstral tension | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| genital discomfort, increased/decreased libido and genitourinary other | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| chest pain, hypotension, Tachycardia, EKG abnormality, and other cardiovascular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| earache, poor hearing, Tinnitus, and ear other | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| eye irritation, blurred vision, eye other | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Accidental Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Muscle Bone joint pain, Dyskinesia, Muscle Rigidity, and Musclualrsketetal other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Mouth Ulcer, Dry mouth, sore tongue, gum problems, Dental problems, and mouth other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Stomach or abdominal discomfort, nausea, vomitting, diarrhea, constipation, stool discoloration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| appetite increase/decrease, taste abnormality, increased thirst, and gastrointestinal other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| headache, dizziness, akathisia, tremor, tic movements, slurred speech, and confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| concentration difficulty and memory problems | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Painful urination, difficulty urinating, increased frequency, and enuresis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |