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 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
NCT ID:
NCT00437658
Description:
None
Frequency Threshold:
5
Time Frame:
From first dose of study drug through 24 weeks after last dose (48 weeks)
Study:
NCT00437658
Study Brief:
Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Elagolix 150 mg QD | Participants received elagolix 150 mg orally once a day (QD) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12. | 0 | None | 3 | 84 | 63 | 84 | View |
| Elagolix 75 mg BID | Participants received elagolix 75 mg orally twice a day (BID) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12. | 0 | None | 3 | 84 | 59 | 84 | View |
| DMPA-SC | Participants received placebo to elagolix orally once a day for 24 weeks and DMPA-SC 104 mg by subcutaneous injection at weeks 1 and 12. | 0 | None | 6 | 84 | 63 | 84 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| FOOD POISONING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 6.1 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 6.1 | View |
| APPENDICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 6.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 6.1 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 6.1 | View |
| OVARIAN DYSGERMINOMA STAGE I | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | medDRA 6.1 | View |
| MIGRAINE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 6.1 | View |
| DEPRESSION SUICIDAL | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA 6.1 | View |
| PELVIC CONGESTION | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | medDRA 6.1 | View |
| PELVIC PAIN | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | medDRA 6.1 | View |
| PNEUMOTHORAX | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 6.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 6.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 6.1 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 6.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 6.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 6.1 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 6.1 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 6.1 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 6.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 6.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 6.1 | View |
| VAGINAL MYCOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 6.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA 6.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA 6.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 6.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 6.1 | View |
| MIGRAINE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 6.1 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA 6.1 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA 6.1 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA 6.1 | View |
| MOOD SWINGS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA 6.1 | View |
| OVARIAN CYST | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | medDRA 6.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 6.1 | View |
| NASAL CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 6.1 | View |
| PHARYNGOLARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 6.1 | View |
| SINUS CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 6.1 | View |
| ACNE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA 6.1 | View |