NCT02254278 · OUTCOME
Percentage of Participants Positive for Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) After Treatment (Detection Rate)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Between 2 weeks to 1 month after treatment completion (approximately 6 weeks).
What was measured
Positive HPV DNA status is defined as 5 or more HPV DNA fragments per mL of blood plasma, assessed by tumor-tissue modified viral (TTMV) testing.
Analysis population: Eligible participants with post-treatment HPV DNA value
Groups in this outcome
IMRT 6 Weeks + Cisplatin (Arm 1)
Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy
IMRT 5 Weeks (Arm 2)
IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
| Group | Source count |
|---|---|
| IMRT 6 Weeks + Cisplatin (Arm 1) | 60 |
| IMRT 5 Weeks (Arm 2) | 69 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IMRT 6 Weeks + Cisplatin (Arm 1) | 3.3 | Not reported | 0.4 | 11.5 | Not reported |
| IMRT 5 Weeks (Arm 2) | 8.7 | Not reported | 3.3 | 18.0 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.28
- statistical Comment
- Two-sided significance level = 0.05
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.28
- statistical Comment
- Two-sided significance level = 0.05
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.4
- upper Limit
- 11.5
- value
- 3.3
- group Id
- OG001
- lower Limit
- 3.3
- upper Limit
- 18.0
- value
- 8.7
- denoms
- counts
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 69
- units
- Participants
- description
- Positive HPV DNA status is defined as 5 or more HPV DNA fragments per mL of blood plasma, assessed by tumor-tissue modified viral (TTMV) testing.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy
- id
- OG000
- title
- IMRT 6 Weeks + Cisplatin (Arm 1)
- description
- IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
- id
- OG001
- title
- IMRT 5 Weeks (Arm 2)
- param Type
- NUMBER
- population Description
- Eligible participants with post-treatment HPV DNA value
- reporting Status
- POSTED
- time Frame
- Between 2 weeks to 1 month after treatment completion (approximately 6 weeks).
- title
- Percentage of Participants Positive for Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) After Treatment (Detection Rate)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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