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 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
NCT ID:
NCT02354534
Description:
All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention.
Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Frequency Threshold:
0
Time Frame:
41 weeks
Study:
NCT02354534
Study Brief:
Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 50 mg Artesunate Suppositories, 1 Cycle | Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories | 0 | None | 0 | 3 | 2 | 3 | View |
| 200 mg Artesunate Suppositories, 1 Cycle | Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories | 0 | None | 0 | 9 | 9 | 9 | View |
| 200 mg Artesunate Suppositories,2 Cycles | Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories | 0 | None | 0 | 10 | 8 | 10 | View |
| 200 mg Artesunate Suppositories,3 Cycles | Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories | 0 | None | 0 | 8 | 8 | 8 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Salivary duct inflammation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Flu-like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Vaginal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Vaginal twitching | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Cystitis noninfective | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Uterine cramping | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| Dyspareunia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| Vaginal discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| Vaginal dryness | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| Vaginal hemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| vaginal inflammation | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| vaginal pain/burning | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Vaginal pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Bloating | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.0) | View |