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 @ 3:25 PM
Ignite Modification Date:
2025-12-25 @ 1:42 PM
NCT ID:
NCT02920892
Description:
Adverse event review were done at all study visits, and during dose titration reviews. Safety monitoring was based on close observation of the child by the family. Children in the proposed age range who have developmental delay with a mental age of approximately 1-5 years are not be able to spontaneously communicate all (if any) side effects. Therefore, adverse event information was collected by querying caregivers about any differences in the child's behavior or wellbeing.
Frequency Threshold:
5
Time Frame:
Participants were monitored for AEs from the time they signed the consent until the final Study visit, up to 21 months. If an AE was ongoing or discovered at a subject's final Study visit, the AE was followed until resolution, or for a minimum of 30 days, whichever comes first.
Study:
NCT02920892
Study Brief:
AFQ056 for Language Learning in Children With FXS
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Double-Blind Period: AFQ056 With Language Intervention | Double-Blind Placebo Period: After a 4-month single-blind placebo lead-in period, subjects with FXS were randomized to receive AFQ056 suspension by mouth twice per day in an 8 month double-blind treatment period. During the double-blind treatment period, subjects in the AFQ056 treatment group began with a dose of 25 mg AFQ056 twice per day and titrated to their maximum tolerated dose over the course of 7 weeks. After 7 weeks the dose was fixed, and at the 2 month visit, the intensive language intervention was initiated. Subjects continued the language intervention while remaining on a stable dose of AFQ056 (ranging from 12.5 mg BID to 100 mg BID), for the next 6 months. Safety and efficacy assessments were performed throughout. | 0 | None | 0 | 50 | 45 | 50 | View |
| Open-Label Period: AFQ056 With Language Intervention | After 8 months of treatment in the placebo-controlled phase, all subjects had assessments completed and were given the opportunity to enter the open-label extension (OLE) in which all subjects received AFQ056. The OLE began with 2 months of flexible dose titration to each subject's maximum tolerated dose followed by a period of stable treatment. Subjects also continued the language intervention through the extension phase. The total duration of the OLE depended on when the subject was enrolled into the study and ranged from no open label to 8 months. The OLE included 46 patients who were previously assigned to placebo and 43 patients who were previously assigned to AFQ056. | 0 | None | 1 | 89 | 76 | 89 | View |
| Placebo Lead-In Period | Children with FXS were seen for a screening visit and if they met entry criteria, they began a single-blind 4-month placebo lead-in period prior to randomization during which they received their therapy treatments as usual, with no language intervention. | 0 | None | 1 | 110 | 65 | 110 | View |
| Double-Blind Period: Placebo With Language Intervention | Double-Blind Placebo Period: After a 4-month single-blind placebo lead-in period, subjects with FXS were randomized to receive a placebo suspension by mouth twice per day in an 8 month double-blind treatment period. During the double-blind treatment period, dose titration to maximum tolerated dose of matching placebo occurred over 7 weeks. After 7 weeks, the dose was fixed, and at the 2 month visit, the intensive language intervention was initiated. Subjects continued the language intervention while remaining on placebo for the next 6 months. Safety and efficacy assessments were performed throughout. | 0 | None | 1 | 49 | 44 | 49 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Otitis Media | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Psychomotor Hyperactivity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Sensory Processing Disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Aggression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Attention Deficit Hyperactivity Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Perseveration | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Sleep Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Pharyngitis Streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |