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 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
NCT ID:
NCT01084135
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT01084135
Study Brief:
Rivastigmine Study in Adolescents With Down 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 |
|---|---|---|---|---|---|---|---|---|
| 20 Week: Rivastigmine- Liquid Form | At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study. | None | None | 0 | 12 | 11 | 12 | View |
| 20 Week: Liquid Placebo | Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste. | None | None | 0 | 11 | 8 | 11 | View |
| 12 Week: Rivastigmine- Liquid Form | At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional four weeks. At the week 6 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 6 weeks. | None | None | 0 | 4 | 3 | 4 | View |
| 12 Week: Liquid Placebo | Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste. | None | None | 0 | 4 | 4 | 4 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | None | Gastrointestinal disorders | None | View |
| Stomach ache | None | Gastrointestinal disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Dizziness | None | Nervous system disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Trouble sleeping | None | Nervous system disorders | None | View |
| Decreased appetite | None | Metabolism and nutrition disorders | None | View |
| Shakiness | None | Nervous system disorders | None | View |
| Weakness | None | Musculoskeletal and connective tissue disorders | None | View |
| Lumps in neck | None | Blood and lymphatic system disorders | None | View |
| Nasal congestion | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Boil | None | Skin and subcutaneous tissue disorders | None | View |
| Menstural cramps | None | Reproductive system and breast disorders | None | View |
| Cut | None | Injury, poisoning and procedural complications | None | View |
| Restless legs | None | Nervous system disorders | None | View |
| Pale coloring | None | Skin and subcutaneous tissue disorders | None | View |
| Eye twitch | None | Eye disorders | None | View |
| Increased bilirubin | None | Hepatobiliary disorders | None | View |
| Indigestion | None | Gastrointestinal disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Worsening acne | None | Skin and subcutaneous tissue disorders | None | View |
| Cold | None | General disorders | None | View |
| Stomach flu | None | General disorders | None | View |
| Fever | None | General disorders | None | View |
| Worsening alopecia | None | Skin and subcutaneous tissue disorders | None | View |
| Leg cramps | None | Musculoskeletal and connective tissue disorders | None | View |
| Incontinence | None | Renal and urinary disorders | None | View |
| Assertive, stubborn, more emotional | None | Psychiatric disorders | None | View |
| Fainted | None | Nervous system disorders | None | View |
| Sleepy | None | Gastrointestinal disorders | None | View |
| Fatigue | None | General disorders | None | View |
| Frequent urination | None | Renal and urinary disorders | None | View |
| Weight gain | None | Metabolism and nutrition disorders | None | View |
| excessive gas | None | Gastrointestinal disorders | None | View |
| behavior problems | None | Psychiatric disorders | None | View |
| Vaginal yeast infection | None | Infections and infestations | None | View |
| Urinary track infection | None | Renal and urinary disorders | None | View |
| nightmares | None | Psychiatric disorders | None | View |
| acne | None | Skin and subcutaneous tissue disorders | None | View |
| Foot twitching | None | Nervous system disorders | None | View |
| Itchy | None | Skin and subcutaneous tissue disorders | None | View |
| Rash | None | Skin and subcutaneous tissue disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |