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 @ 7:57 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
NCT ID:
NCT01010204
Description:
None
Frequency Threshold:
5
Time Frame:
6 months
Study:
NCT01010204
Study Brief:
Varenicline Treatment for Smoking Cessation in Patients With 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 |
|---|---|---|---|---|---|---|---|---|
| Varenicline | We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study. Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water. | None | None | 6 | 31 | 29 | 31 | View |
| Placebo | We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder. Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water. | None | None | 4 | 29 | 25 | 29 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| exacerbation of anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| agitation, hostility, alcohol drug abuse | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| asthma with acute exacerbation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| alcohol intoxication | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| upper left arm weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| chest pain, left hand numbness | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| mood swings | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| dry mouth | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| flatulance | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| heart burn | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| gastroesophageal reflux | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| depressed mood | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| abnormal dreams | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| bad taste | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| arthralgia/pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| fatigue/lethargy | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| asthenia-weakness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| runny nose | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| shortness of breath | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| increased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| weight gain | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| weight loss | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |