TriangleNCT00293462 · OUTCOME
Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- From baseline to onset of mucositis, approximately 16 days
What was measured
The number of participants with recorded grade 1 (mild; Irritation, may experience slight pain, not requiring analgesic) or grade 2 (moderate; Patchy mucositis that may produce inflammatory serosanguinitis discharge; may experience moderate pain requiring analgesia) oral mucositis using the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria Oral Mucosa Assessment Scale at baseline and during radiotherapy will be recorded. The RTOG grading is reliant on a clinician's ability to judge the anatomical changes associated with oral mucositis (size and characteristics of ulceration), with symptoms ranging from Grade 0 (no symptoms) to Grade 4 (Ulceration, hemorrhage, or necrosis). A comparison of incidence in the GM-CSF Group (GG) and Arm II: Salt \& Soda Group (SS) will be reported.
Analysis population: Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash
Groups in this outcome
Arm I: GM-CSF Group (GG)
Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Arm II: Salt & Soda Group (SS)
Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
| Group | Source count |
|---|---|
| Arm I: GM-CSF Group (GG) | 28 |
| Arm II: Salt & Soda Group (SS) | 53 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I: GM-CSF Group (GG) | 28 | Not reported | Not reported | Not reported | Not reported |
| Arm II: Salt & Soda Group (SS) | 46 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Pct Value
- 95
- group Description
- Fisher's exact two tailed test
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.09
- statistical Comment
- Two by two table was used. One cell had expected frequency test less than five, so Fisher's exact two-tailed test was used.
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- ci Pct Value
- 95
- group Description
- Fisher's exact two tailed test
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.09
- statistical Comment
- Two by two table was used. One cell had expected frequency test less than five, so Fisher's exact two-tailed test was used.
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 46
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 53
- units
- Participants
- description
- The number of participants with recorded grade 1 (mild; Irritation, may experience slight pain, not requiring analgesic) or grade 2 (moderate; Patchy mucositis that may produce inflammatory serosanguinitis discharge; may experience moderate pain requiring analgesia) oral mucositis using the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria Oral Mucosa Assessment Scale at baseline and during radiotherapy will be recorded. The RTOG grading is reliant on a clinician's ability to judge the anatomical changes associated with oral mucositis (size and characteristics of ulceration), with symptoms ranging from Grade 0 (no symptoms) to Grade 4 (Ulceration, hemorrhage, or necrosis). A comparison of incidence in the GM-CSF Group (GG) and Arm II: Salt \& Soda Group (SS) will be reported.
- groups
- description
- Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
- id
- OG000
- title
- Arm I: GM-CSF Group (GG)
- description
- Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
- id
- OG001
- title
- Arm II: Salt & Soda Group (SS)
- param Type
- NUMBER
- population Description
- Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash
- reporting Status
- POSTED
- time Frame
- From baseline to onset of mucositis, approximately 16 days
- title
- Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice