Just want to clarify on the reduction of time frame.
Before
Primary Outcome Measure: Efficacy Assessed by Sequential WHO Oral Mucositis Score [Time Frame: 11 weeks]
Description: Efficacy of the study drug oral rinse will be assessed by trained site personnel twice-weekly. The WHO OM Score will be the primary measure for assessment of presence and severity of OM.
After
Primary Outcome Measure: Incidence of ulcerative and severe oral mucositis (WHO Grade >
) [Time Frame: 7 weeks]
Description: Incidence of ulcerative and severe oral mucositis, defined as grade 3 or 4 on the WHO Oral Mucositis score, experienced during radiation therapy by patients with head and neck cancer receiving a cumulative radiation dose of at least 55 Gy. The WHO Score will be assessed by trained site personnel twice-weekly.
Primary Outcome Measure: Incidence of Treatment-Emergent Adverse Events [Time Frame: 11 weeks]
Description: Reporting of Adverse Events and severity of adverse events
The total time frame didn't change (still 11 weeks). Instead, one more measure was added after 7 weeks.
Before
Primary Outcome Measure: Efficacy Assessed by Sequential WHO Oral Mucositis Score [Time Frame: 11 weeks]
Description: Efficacy of the study drug oral rinse will be assessed by trained site personnel twice-weekly. The WHO OM Score will be the primary measure for assessment of presence and severity of OM.
After
Primary Outcome Measure: Incidence of ulcerative and severe oral mucositis (WHO Grade >
) [Time Frame: 7 weeks] Description: Incidence of ulcerative and severe oral mucositis, defined as grade 3 or 4 on the WHO Oral Mucositis score, experienced during radiation therapy by patients with head and neck cancer receiving a cumulative radiation dose of at least 55 Gy. The WHO Score will be assessed by trained site personnel twice-weekly.
Primary Outcome Measure: Incidence of Treatment-Emergent Adverse Events [Time Frame: 11 weeks]
Description: Reporting of Adverse Events and severity of adverse events
The total time frame didn't change (still 11 weeks). Instead, one more measure was added after 7 weeks.
Quote:The reduction in time frame tells me that B is working on the OM faster then originally anticipated.
2
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