TriangleNCT06263582 · OUTCOME
Type, Frequency, Severity, and Duration of Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to day 10 days
What was measured
To investigate the safety of a 5-day course of self-administered intravaginal artesunate vaginal inserts (pessary) in women. Type, frequency, severity, and duration of reported and observed adverse events (AEs) using the U.S National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0 (CTCAE 5.0) and the Division of AIDS Female Genital Adverse Events Grading Table will be submitted.
Groups in this outcome
Artesunate Vaginal Inserts/ Pessaries
Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions. Artesunate pessary: Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
| Group | Source count |
|---|---|
| Artesunate Vaginal Inserts/ Pessaries | 12 |
Reported measurements
abdominal pain Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Artesunate Vaginal Inserts/ Pessaries | 3 | Not reported | Not reported | Not reported | Not reported |
vaginal discharge Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Artesunate Vaginal Inserts/ Pessaries | 8 | Not reported | Not reported | Not reported | Not reported |
Toothache- Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Artesunate Vaginal Inserts/ Pessaries | 1 | Not reported | Not reported | Not reported | Not reported |
vaginal fistula- Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Artesunate Vaginal Inserts/ Pessaries | 1 | Not reported | Not reported | Not reported | Not reported |
vaginal pruritis- Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Artesunate Vaginal Inserts/ Pessaries | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- title
- abdominal pain Grade 1
- categories
- measurements
- group Id
- OG000
- value
- 8
- title
- vaginal discharge Grade 1
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Toothache- Grade 1
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- vaginal fistula- Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- vaginal pruritis- Grade 1
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- description
- To investigate the safety of a 5-day course of self-administered intravaginal artesunate vaginal inserts (pessary) in women. Type, frequency, severity, and duration of reported and observed adverse events (AEs) using the U.S National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0 (CTCAE 5.0) and the Division of AIDS Female Genital Adverse Events Grading Table will be submitted.
- groups
- description
- Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions. Artesunate pessary: Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
- id
- OG000
- title
- Artesunate Vaginal Inserts/ Pessaries
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to day 10 days
- title
- Type, Frequency, Severity, and Duration of Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice