NCT02254278 · OUTCOME
Percentage of Participants With Grade 3+ Adverse Events
Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer · Source last updated 2026-05-22
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
- End of radiation therapy (RT) (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2), then 1 month, 6 months, 1 year, and two years after end of RT
What was measured
Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.
Analysis population: Randomized and eligible participants who started study treatment. Adverse event data was not available for all participants at each time point.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| IMRT 6 Weeks + Cisplatin (Arm 1) | 152 |
|---|
| IMRT 5 Weeks (Arm 2) | 147 |
|---|
Reported measurements
End of RT
Analysis denominator · Participants
| Group | Source count |
|---|
| IMRT 6 Weeks + Cisplatin (Arm 1) | 152 |
|---|
| IMRT 5 Weeks (Arm 2) | 147 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| IMRT 6 Weeks + Cisplatin (Arm 1) | 73.7 | Not reported | 65.9 | 80.5 | Not reported |
|---|
| IMRT 5 Weeks (Arm 2) | 46.3 | Not reported | 38.0 | 54.7 | Not reported |
|---|
1 month post-RT
Analysis denominator · Participants
| Group | Source count |
|---|
| IMRT 6 Weeks + Cisplatin (Arm 1) | 144 |
|---|
| IMRT 5 Weeks (Arm 2) | 142 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| IMRT 6 Weeks + Cisplatin (Arm 1) | 36.1 | Not reported | 28.3 | 44.5 | Not reported |
|---|
| IMRT 5 Weeks (Arm 2) | 28.2 | Not reported | 21.0 | 36.3 | Not reported |
|---|
6 months post-RT
Analysis denominator · Participants
| Group | Source count |
|---|
| IMRT 6 Weeks + Cisplatin (Arm 1) | 140 |
|---|
| IMRT 5 Weeks (Arm 2) | 126 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| IMRT 6 Weeks + Cisplatin (Arm 1) | 17.9 | Not reported | 11.9 | 25.2 | Not reported |
|---|
| IMRT 5 Weeks (Arm 2) | 11.1 | Not reported | 6.2 | 17.9 | Not reported |
|---|
1 year post-RT
Analysis denominator · Participants
| Group | Source count |
|---|
| IMRT 6 Weeks + Cisplatin (Arm 1) | 143 |
|---|
| IMRT 5 Weeks (Arm 2) | 134 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| IMRT 6 Weeks + Cisplatin (Arm 1) | 14.0 | Not reported | 8.8 | 20.8 | Not reported |
|---|
| IMRT 5 Weeks (Arm 2) | 9.0 | Not reported | 4.7 | 15.1 | Not reported |
|---|
2 years post-RT
Analysis denominator · Participants
| Group | Source count |
|---|
| IMRT 6 Weeks + Cisplatin (Arm 1) | 128 |
|---|
| IMRT 5 Weeks (Arm 2) | 122 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| IMRT 6 Weeks + Cisplatin (Arm 1) | 8.6 | Not reported | 4.4 | 14.9 | Not reported |
|---|
| IMRT 5 Weeks (Arm 2) | 7.4 | Not reported | 3.4 | 13.5 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- group Description
- End of RT
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Comment
- Two-sided significance level = 0.05
- statistical Method
- Fisher Exact
- group Description
- One month after end of RT
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.17
- statistical Comment
- Two-sided significance level = 0.05
- statistical Method
- Fisher Exact
- group Description
- Six months after end of RT
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.16
- statistical Comment
- Two-side significance level = 0.05
- statistical Method
- Fisher Exact
- group Description
- One year after end of RT
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.26
- statistical Comment
- Two-side significance level = 0.05
- statistical Method
- Fisher Exact
- group Description
- Two years after the end of RT
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.82
- statistical Comment
- Two-side significance level = 0.05
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- group Description
- End of RT
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Comment
- Two-sided significance level = 0.05
- statistical Method
- Fisher Exact
- group Description
- One month after end of RT
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.17
- statistical Comment
- Two-sided significance level = 0.05
- statistical Method
- Fisher Exact
- group Description
- Six months after end of RT
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.16
- statistical Comment
- Two-side significance level = 0.05
- statistical Method
- Fisher Exact
- group Description
- One year after end of RT
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.26
- statistical Comment
- Two-side significance level = 0.05
- statistical Method
- Fisher Exact
- group Description
- Two years after the end of RT
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.82
- statistical Comment
- Two-side significance level = 0.05
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 65.9
- upper Limit
- 80.5
- value
- 73.7
- group Id
- OG001
- lower Limit
- 38.0
- upper Limit
- 54.7
- value
- 46.3
- denoms
- counts
- group Id
- OG000
- value
- 152
- group Id
- OG001
- value
- 147
- units
- Participants
- title
- End of RT
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.3
- upper Limit
- 44.5
- value
- 36.1
- group Id
- OG001
- lower Limit
- 21.0
- upper Limit
- 36.3
- value
- 28.2
- denoms
- counts
- group Id
- OG000
- value
- 144
- group Id
- OG001
- value
- 142
- units
- Participants
- title
- 1 month post-RT
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.9
- upper Limit
- 25.2
- value
- 17.9
- group Id
- OG001
- lower Limit
- 6.2
- upper Limit
- 17.9
- value
- 11.1
- denoms
- counts
- group Id
- OG000
- value
- 140
- group Id
- OG001
- value
- 126
- units
- Participants
- title
- 6 months post-RT
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.8
- upper Limit
- 20.8
- value
- 14.0
- group Id
- OG001
- lower Limit
- 4.7
- upper Limit
- 15.1
- value
- 9.0
- denoms
- counts
- group Id
- OG000
- value
- 143
- group Id
- OG001
- value
- 134
- units
- Participants
- title
- 1 year post-RT
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.4
- upper Limit
- 14.9
- value
- 8.6
- group Id
- OG001
- lower Limit
- 3.4
- upper Limit
- 13.5
- value
- 7.4
- denoms
- counts
- group Id
- OG000
- value
- 128
- group Id
- OG001
- value
- 122
- units
- Participants
- title
- 2 years post-RT
- denoms
- counts
- group Id
- OG000
- value
- 152
- group Id
- OG001
- value
- 147
- units
- Participants
- description
- Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.
- 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
- Randomized and eligible participants who started study treatment. Adverse event data was not available for all participants at each time point.
- reporting Status
- POSTED
- time Frame
- End of radiation therapy (RT) (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2), then 1 month, 6 months, 1 year, and two years after end of RT
- title
- Percentage of Participants With Grade 3+ Adverse Events
- 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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