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 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
NCT ID:
NCT00245635
Description:
Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
Frequency Threshold:
0
Time Frame:
Adverse Event data was collected throughout the course of the study.
Study:
NCT00245635
Study Brief:
Fluoxetine in Pediatric Body Dysmorphic Disorder
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Fluoxetine | Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day. Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score. | None | None | 1 | 25 | 2 | 25 | View |
| Placebo | Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug. Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score. | None | None | 0 | 18 | 3 | 18 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Suicidal Behavior | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Weight Loss | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Trouble Sleeping | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Nightmares | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Stomach Pains | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Sweating | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Agitated/Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Silliness/Feeling too happy | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Lit Paper on Fire | SYSTEMATIC_ASSESSMENT | Social circumstances | None | View |
| Emotional | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Menstrual Cramps | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Forgetfulness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Light hurts eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Feeling tense | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Ears ringing | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Blurred/double Vision | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Visit to ER: Family Conflict | SYSTEMATIC_ASSESSMENT | Social circumstances | None | View |
| Visit to ER: Aches | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Itchiness | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Leg Spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hair Loss | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Delay in Urination | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Numbness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Tingling | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Heart Pounding/Racing | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Trouble Keeping Balance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Room Spinning | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Weight Gain | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |