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:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
NCT ID:
NCT00958633
Description:
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase.
The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
Frequency Threshold:
1
Time Frame:
4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
Study:
NCT00958633
Study Brief:
Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar 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 |
|---|---|---|---|---|---|---|---|---|
| 8 Week Arm | During the double-blind phase, all patients will continue treatment with their anti-manic medication(s)and will be randomized to one of two treatment arms for up to 52 weeks: Group 1 patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines. The antidepressant will be tapered in a double-blind manner beginning at 6 weeks, and will be substituted with placebo by 8 weeks. Escitalopram 10 - 30 mg or Wellbutrin XL 150 - 450 mg | 0 | None | 0 | 87 | 59 | 87 | View |
| 52 Week Arm | During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks: Group 2 patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study. Escitalopram 10 - 30 mg or Wellbutrin XL 150 - 450 mg | 0 | None | 0 | 90 | 57 | 90 | View |
| Open-Label Phase (4-16 Weeks) | Patients with BD depression who are receiving treatment with antimanic medication(s) will have open-label escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day added to their medication(s) for up to 16 weeks.Patients who complete at least 4 weeks of treatment and achieve remission from their index depression which is maintained for ≥ 2 weeks will be eligible to enter the double-blind study phase. The duration of treatment in the open-label phase will be 4-16 weeks, depending on the time required to achieve remission. | 0 | None | 1 | 206 | 87 | 206 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalization due to discontinuation of treatment, alcohol and drug use | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypersomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Increased sex drive | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Memory problems | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Muscle pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Poor concentration | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Sleep disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Weight gain ≥7% | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Other | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Mania | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Blurred Vision | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Weight Gain | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Abdominal pain or bloating | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Decreased sex drive | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Decreased sleep | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Feeling faint | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Fatigue or tiredness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Heartburn | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |