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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
NCT ID:
NCT00866294
Description:
None
Frequency Threshold:
5
Time Frame:
AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
Study:
NCT00866294
Study Brief:
Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Paroxetine IR, Total | All participants receiving either paroxetine IR 10-40 mg/day or 20-40 mg/day | None | None | 2 | 83 | 44 | 83 | View |
| Paroxetine CR, Total | All participants receiving either paroxetine CR 12.5-50 mg/day or 25-50 mg/day | None | None | 6 | 161 | 93 | 161 | View |
| Placebo | Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks). | None | None | 1 | 172 | 76 | 172 | View |
| Paroxetine CR 12.5-50 mg/Day | An initial dose of 12.5 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 25 mg/day, and 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment. | None | None | 2 | 79 | 43 | 79 | View |
| Paroxetine CR 25-50 mg/Day | An initial dose of 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment. | None | None | 4 | 82 | 50 | 82 | View |
| Paroxetine IR 10-40 mg/Day | An initial dose of 10 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 20 mg/day, and 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment. | None | None | 2 | 43 | 23 | 43 | View |
| Paroxetine IR 20-40 mg/Day | An initial dose of 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment. | None | None | 0 | 40 | 21 | 40 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Completed suicide | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Alcohol abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Conversion disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Major depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Drug toxicity | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Withdrawal syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.1 | View |