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 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:48 AM
NCT ID:
NCT02338960
Description:
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
Frequency Threshold:
2
Time Frame:
1 year
Study:
NCT02338960
Study Brief:
2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo (Main Study) | Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours. Placebo: Placebo | 0 | None | 2 | 301 | 137 | 301 | View |
| Bremelanotide (Main Study) | Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours. Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | 0 | None | 3 | 303 | 224 | 303 | View |
| Bremelanotide (OLE) | Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours. Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | 0 | None | 1 | 130 | 93 | 130 | View |
| Placebo (OLE) | Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours. Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) | 0 | None | 0 | 191 | 142 | 191 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Colon cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.1) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | View |
| cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (18.1) | View |
| Gastrointestinal inflammation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Uterine leiomyoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.1) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Fungal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Vulvovaginal mycotic infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.1) | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.1) | View |
| Blood creatine phophokinase | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |
| Injection site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Injection site hematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Paresthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.1) | View |
| Sunburn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |