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 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
NCT ID:
NCT00354432
Description:
None
Frequency Threshold:
5
Time Frame:
12 weeks
Study:
NCT00354432
Study Brief:
Soy Protein/Effexor Hormone Therapy for Prostate Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm I - Placebo | Patients receive oral placebo pill and oral placebo powder once daily. | None | None | 4 | 30 | 28 | 30 | View |
| Arm II - Soy | Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily. | None | None | 5 | 27 | 23 | 27 | View |
| Arm III - Venlafaxine | Patients receive oral Venlafaxine pill and placebo powder once daily. | None | None | 5 | 29 | 29 | 29 | View |
| Arm IV - Soy + Venlafaxine | Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily. | None | None | 5 | 28 | 27 | 28 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Erectile Dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (3.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Infection - Rectum | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Mood alteration - Agitation | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Mood alteration- Anxiety | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Obstruction - Ureter | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Pain - Other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - chest NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - joint | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Vascular - other | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Allergic Reaction/hypersensitivity including drug reaction | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Constitutional Symptioms - Nightmares | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Diarrhea - without colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Distension/Bloating, Abdominal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (3.0) | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Ejaculatory Dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (3.0) | View |
| Erectile Dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (3.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Mood Alteration - Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Mood Alteration - Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Neurology - Nervousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy - Sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Pain - Other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Back | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Extremity - Limb | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - joint | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Petechiae/purpura - hemorrhage/bleeding into skin or mucosa | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Renal/Genitourinary - Other (Specify, __) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Sweating - Diaphoresis | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Urinary Frequency/Urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |