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 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
NCT ID:
NCT01257802
Description:
None
Frequency Threshold:
0
Time Frame:
adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
Study:
NCT01257802
Study Brief:
GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| LUPRON | depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses | 0 | None | 1 | 6 | 5 | 6 | View |
| Placebo | depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses | 0 | None | 1 | 8 | 5 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hospitalization for items listed below: | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hospitalization for items listed below | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| leg striae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| hot flashes | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| hot and cold flashes | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| facial rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| increased sweating | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| 2 menstruations in 28 day cycle | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| fluid retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| worsening hypertension | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| bleeding at catheter site | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| pain in right hip | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| pain in right forearm | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| stool incontinence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| menstrual spotting in between cycles | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| night sweats | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| bacterial overgrowth - GI related | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| arthralgias | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| viral upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| nausea and vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| edema of left calf, foot, and hand | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |