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 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
NCT ID:
NCT00772005
Description:
During each contact with the patient, the investigator queried the patient for adverse events by asking an open-ended question such as, "Have you had any unusual symptoms or medical problems since the last visit? If yes, please describe."
Frequency Threshold:
5
Time Frame:
The study period was defined as that time period from signature of the informed consent form through the end of the follow-up period. For this study, the follow-up period was defined as 7±2 days after the last dose of study drug.
Study:
NCT00772005
Study Brief:
Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 150 mg/Day Armodafinil | At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study. | None | None | 4 | 71 | 32 | 71 | View |
| 200 mg/Day Armodafinil | At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study. | None | None | 5 | 69 | 30 | 69 | View |
| 250 mg/Day Armodafinil | At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study. | None | None | 3 | 71 | 38 | 71 | View |
| Matching Placebo | At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study. | None | None | 5 | 70 | 33 | 70 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Heat exhaustion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Schizophrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Delusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Social stay hospitalisation | SYSTEMATIC_ASSESSMENT | Social circumstances | None | View |
| Arthritis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Alcohol abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Conversion disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Drug abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Paranoia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Adjustment disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Knee operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Initial insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Schizophrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |