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 @ 1:40 PM
Ignite Modification Date:
2025-12-25 @ 12:37 PM
NCT ID:
NCT00305695
Description:
None
Frequency Threshold:
0
Time Frame:
Up to 18 months
Study:
NCT00305695
Study Brief:
Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries
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 II (Clinical Observation) | Patients are observed for 18 months after surgery. | None | None | 0 | 78 | 19 | 78 | View |
| Arm I (Zoledroic Acid) | Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15. Laboratory Biomarker Analysis: Correlative studies Zoledronic Acid: Given IV | None | None | 1 | 80 | 45 | 80 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Taste Alteration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Gastrointestinal - Other | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, Gu - Vagina | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Inf Unknown Anc: Sinus | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Edema: Limb | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Creatinine | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypocalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypercalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Osteoporosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Mental Status | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Mood Alteration - Depression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Mood Alteration - Anxiety | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy-Sensory | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Pain - Other | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain: Pelvis | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain: Vagina | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain: Chest /Thorax Nos | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain: Head/Headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain: Neck | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain: Extremity-Limb | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain: Back | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain: Joint | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain: Bone | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain: Abdominal Pain Nos | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain: External Ear | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain: Muscle | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Incontinence, Urinary | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Urinary Frequency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Vaginal Dryness | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (3.0) | View |
| Flu-Like Syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (3.0) | View |
| Hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Rigors/Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Dry Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Hot Flashes | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (3.0) | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (3.0) | View |