TriangleNCT00101582 · OUTCOME
Number of Participants With Severe (Grade 3 or 4) Oral Mucositis
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
- Up to Week 15
What was measured
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) 2 times weekly throughout radio/chemotherapy, and 2 times weekly thereafter until severe OM returned to grade ≤ 2 or until Week 15. During each evaluation, the following anatomical areas were assessed: upper lip; lower lip; right cheek; left cheek; right ventral \& lateral tongue; left ventral \& lateral tongue; floor of the mouth; hard palate; soft palate. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.
Analysis population: The Full Analysis Set included all randomized participants.
Groups in this outcome
Placebo
Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
Palifermin
Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
| Group | Source count |
|---|---|
| Placebo | 94 |
| Palifermin | 94 |
Reported measurements
Yes
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 62 | Not reported | Not reported | Not reported | Not reported |
| Palifermin | 51 | Not reported | Not reported | Not reported | Not reported |
No
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 29 | Not reported | Not reported | Not reported | Not reported |
| Palifermin | 43 | Not reported | Not reported | Not reported | Not reported |
Unknown
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 3 | Not reported | Not reported | Not reported | Not reported |
| Palifermin | 0 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Pct Value
- 95
- group Description
- Sample size calculations were based on the number of participants needed to detect, with 90% power and 5% type 1 error rate, at least a 25% difference in the incidence of severe OM between the treatment groups. A 25% absolute reduction in the incidence of severe OM from the placebo group was considered by investigators as clinically meaningful in this clinical setting.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0410
- p Value Comment
- Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed as having WHO grade 3 or 4 oral mucositis in hypothesis testing.
- param Type
- Chi-Square Statistic
- param Value
- 4.1764
- statistical Comment
- Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Pct Value
- 95
- group Description
- Sample size calculations were based on the number of participants needed to detect, with 90% power and 5% type 1 error rate, at least a 25% difference in the incidence of severe OM between the treatment groups. A 25% absolute reduction in the incidence of severe OM from the placebo group was considered by investigators as clinically meaningful in this clinical setting.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0410
- p Value Comment
- Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed as having WHO grade 3 or 4 oral mucositis in hypothesis testing.
- param Type
- Chi-Square Statistic
- param Value
- 4.1764
- statistical Comment
- Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 51
- title
- Yes
- categories
- measurements
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 43
- title
- No
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- title
- Unknown
- denoms
- counts
- group Id
- OG000
- value
- 94
- group Id
- OG001
- value
- 94
- units
- Participants
- description
- Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) 2 times weekly throughout radio/chemotherapy, and 2 times weekly thereafter until severe OM returned to grade ≤ 2 or until Week 15. During each evaluation, the following anatomical areas were assessed: upper lip; lower lip; right cheek; left cheek; right ventral \& lateral tongue; left ventral \& lateral tongue; floor of the mouth; hard palate; soft palate. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.
- groups
- description
- Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
- id
- OG000
- title
- Placebo
- description
- Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
- id
- OG001
- title
- Palifermin
- param Type
- NUMBER
- population Description
- The Full Analysis Set included all randomized participants.
- reporting Status
- POSTED
- time Frame
- Up to Week 15
- title
- Number of Participants With Severe (Grade 3 or 4) Oral Mucositis
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice