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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 11:35 PM
NCT ID:
NCT02010593
Description:
All AEs (including deaths and SAE) reported by or observed in enrolled trial participants regardless of severity and presumed relationship to IP was reported in source documents.
Frequency Threshold:
2
Time Frame:
IP 12 weeks + 1 week follow-up
Study:
NCT02010593
Study Brief:
Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dapivirine Vaginal Ring | Safety study of a vaginal ring containing Dapivirine in a postmenopausal female population Dapivirine Vaginal Ring: Dapivirine, a non-nucleoside reverse-transcriptase inhibitor (NNRTI), is a substituted amino- pyrimidine (DAPY) derivative with potent antiviral activity against HIV-1. Dapivirine is chemically described as 4-\[\[4-\[(2,4,6-trimethylphenyl)amino\]-2- pyrimidinyl\]amino\]benzonitrile.6 The dapivirine matrix VR is a flexible ring containing 25 mg of drug substance dispersed in a platinum-catalyzed-cured silicone matrix. Dapivirine is known to be well-suited for delivery via VR | None | None | 1 | 72 | 46 | 72 | View |
| Placebo | The placebo VR is a flexible, platinum-catalyzed-cured matrix ring, identical to Dapivirine Ring-004, containing no active-drug Placebo Vaginal Ring: The placebo VR is a flexible, platinum-catalyzed-cured silicone matrix ring, identical to dapivirine Ring-004, containing no active drug. | None | None | 0 | 24 | 14 | 24 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.1) | View |
| Abdominal Discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Abdominal Pain Lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Vulvovaginitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Cervix haemorrhage uterine | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| Dyspareunia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| Vaginal discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| Vaginal erosion | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| Vaginal odour | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| Vulvovaginal discomfort | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| Vulvovaginal dryness | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| Vulvovaginal erythema | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| Vulvovaginal pruritus | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |