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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:39 PM
NCT ID:
NCT01074294
Description:
Safety Sample consisted of randomized participants who received at least one dose of double-blind IMP as indicated on the dosing record. As pre-specified in the protocol the data for adverse events is presented in Part A, Part B and Part A+ as per the dose received.
Frequency Threshold:
5
Time Frame:
From first dose through 30 days after last dose of study drug (Up to approximately Week 15)
Study:
NCT01074294
Study Brief:
Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity 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 |
|---|---|---|---|---|---|---|---|---|
| Phase A (Single-blind Prospective Treatment Phase): Placebo + Stimulant | Participants received single-blind matching-placebo tablets along with open-label stimulant determined by the investigator, once daily for 5 weeks. Once assigned to a stimulant by the investigator, participants remained on the same stimulant for the duration of the trial. Participants who met eligibility criteria i.e., who received prior treatment for adult ADHD and treatment-naïve participants were included in this arm group. Participants with incomplete response at the end of Phase A (Week 5) entered Phase B and rest of the participants continued to Phase A+. | 0 | None | 0 | 733 | 440 | 733 | View |
| Phase B (Double-blind Randomization Phase): Brexpiprazole + Stimulant | Participants with incomplete response (with a \> 0% and \< 30% reduction in ADHD Symptoms Total Score {18 items} between the Baseline of Phase A and the end of prospective treatment {Week 5} as measured by the CAARS-O:SV {Conners' Adult ADHD Rating Scale-Observer: Screening Version}, and a CAARS-O:SV ADHD Symptoms Total Score {18 items} of ≥ 24 at Week 5, and a CGI-I score of 3 or 4 at Week 5) at the end of Phase A (Week 5), received Brexpiprazole 2mg tablet along with stimulant determined by the investigator, once daily for 6 weeks (up to Week 11). | 0 | None | 0 | 155 | 32 | 155 | View |
| Phase B (Double-blind Randomization Phase): Placebo + Stimulant | Participants with incomplete response (with a \> 0% and \< 30% reduction in ADHD Symptoms Total Score {18 items} between the Baseline of Phase A and the end of prospective treatment {Week 5} as measured by the CAARS-O:SV, and a CAARS-O:SV ADHD Symptoms Total Score {18 items} of ≥ 24 at Week 5, and a CGI-I score of 3 or 4 at Week 5) at the end of Phase A (Week 5), received matching-placebo tablets along with stimulant determined by the investigator, once daily for 6 weeks (up to Week 11). | 0 | None | 2 | 80 | 25 | 80 | View |
| Phase A+ (Single-blind Phase A Responders and Non-responders): Placebo + Stimulant | Participants with response (with a ≥ 30% reduction in ADHD Symptoms Total Score {18 items} between Baseline of Phase A and the end of prospective treatment {Week 5} as measured by the CAARS-O:SV, or a CAARS-O:SV ADHD Symptoms Total Score {18 items} of \< 24 at Week 5, or a CGI-I score of \< 3 at Week 5) and non-response (with deterioration or no change in ADHD symptoms at Week 5) at the end of Phase A (Week 5), received single-blind matching-placebo tablets along with open-label stimulant determined by the investigator, once daily for an additional 6 weeks (up to Week 11). | 0 | None | 0 | 339 | 17 | 339 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 11.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |