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 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 10:20 AM
NCT ID:
NCT00110461
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00110461
Study Brief:
Aripiprazole in Children and Adolescents With Bipolar I 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 |
|---|---|---|---|---|---|---|---|---|
| Aripiprazole 10 mg/Day | Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed. | None | None | 5 | 98 | 78 | 98 | View |
| Aripiprazole 30 mg/Day | Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed. | None | None | 7 | 99 | 84 | 99 | View |
| Placebo | Participants were given a single pill administered once daily. | None | None | 6 | 97 | 64 | 97 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Grand mal convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Agression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| Bipolar disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| Bipolar I disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| Libido increased | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| Mania | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| Oppositional defiant disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| Suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| Respiratory arrest | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Accidental overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (9.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| Salivary hypersecretion | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| Stomach discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| Increased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| Akathisia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Dystonia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Extrapyramidal disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Anxiety, upper | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| Bipolar disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| Dysmenorrhea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (9.1) | View |
| Cough, upper | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| Pharyngolaryngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |