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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
NCT ID:
NCT02058693
Description:
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
Frequency Threshold:
0
Time Frame:
AE data were collected over the seven weeks of the trial.
Study:
NCT02058693
Study Brief:
Adjunctive Mixed Salts Amphetamine for Depressed Adults With Incomplete Response to Current Antidepressant Therapy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group 1(A): Placebo/MSA | Phase I (3 weeks) placebo adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR (controlled release) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine XR (extended release) 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions). Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT (as in Phase I). mixed salts amphetamine: adjunctive to ADT | 0 | None | 0 | 16 | 8 | 16 | View |
| Group 2(B): MSA/MSA | Phase I (3 weeks) mixed salts amphetamine adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR (controlled release) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine XR (extended release) 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions). Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT (as in Phase I). mixed salts amphetamine: adjunctive to ADT | 0 | None | 0 | 16 | 9 | 16 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Agitation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Angioedema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Bad taste | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA | View |
| Blurred vision | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Body ache | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Bruising | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Mild heart tremor | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Racy feelings | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Acid reflux | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Injury: slip and fall, bruising | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Sweating | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Watery, itchy eyes | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Word finding | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |