NCT02180867 · OUTCOME
Percentage of Patients Who Experienced Grade 3 or Higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year
What was measured
Participants who experienced Grade 3 or higher toxicity was assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Analysis population: Ineligible patients are excluded.
Groups in this outcome
Dose-Finding Level 1 CR
Dose-Finding Level 1 CR: Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2
Dose-Finding Level 1 RT
Dose-Finding Level 1 RT: Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2
Dose-Finding Level 2 RT
Dose-Finding Level 2 RT: Adult: Pazopanib 800 mg; Pediatric: Pazopanib 450 mg/m2
Regimen A
Regimen A: Chemoradiation plus pazopanib
Regimen B
Regimen B: Chemoradiation alone
Regimen C
Regimen C: Radiation therapy plus pazopanib
Regimen D
Regimen D: Radiation therapy alone
| Group | Source count |
|---|---|
| Dose-Finding Level 1 CR | 9 |
| Dose-Finding Level 1 RT | 9 |
| Dose-Finding Level 2 RT | 10 |
| Regimen A | 46 |
| Regimen B | 43 |
| Regimen C | 6 |
| Regimen D | 6 |
Reported measurements
Pediatric Patients
| Group | Source count |
|---|---|
| Dose-Finding Level 1 CR | 5 |
| Dose-Finding Level 1 RT | 3 |
| Dose-Finding Level 2 RT | 3 |
| Regimen A | 16 |
| Regimen B | 18 |
| Regimen C | 1 |
| Regimen D | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose-Finding Level 1 CR | 60 | Not reported | 17.06 | 100 | Not reported |
| Dose-Finding Level 1 RT | 66.67 | Not reported | 13.32 | 100 | Not reported |
| Dose-Finding Level 2 RT | 33.33 | Not reported | 0 | 86.68 | Not reported |
| Regimen A | 75 | Not reported | 53.78 | 96.22 | Not reported |
| Regimen B | 33.33 | Not reported | 11.56 | 55.11 | Not reported |
| Regimen C | 0 | Not reported | 0 | 0 | Not reported |
Adult Patients
| Group | Source count |
|---|---|
| Dose-Finding Level 1 CR | 4 |
| Dose-Finding Level 1 RT | 6 |
| Dose-Finding Level 2 RT | 7 |
| Regimen A | 30 |
| Regimen B | 25 |
| Regimen C | 5 |
| Regimen D | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose-Finding Level 1 CR | 75 | Not reported | 32.56 | 100 | Not reported |
| Dose-Finding Level 1 RT | 66.67 | Not reported | 28.95 | 100 | Not reported |
| Dose-Finding Level 2 RT | 57.14 | Not reported | 20.48 | 93.80 | Not reported |
| Regimen A | 86.67 | Not reported | 74.50 | 98.83 | Not reported |
| Regimen B | 36 | Not reported | 17.18 | 54.82 | Not reported |
| Regimen C | 40 | Not reported | 0 | 82.94 | Not reported |
| Regimen D | 0 | Not reported | 0 | 0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.06
- upper Limit
- 100
- value
- 60
- group Id
- OG001
- lower Limit
- 13.32
- upper Limit
- 100
- value
- 66.67
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 86.68
- value
- 33.33
- group Id
- OG003
- lower Limit
- 53.78
- upper Limit
- 96.22
- value
- 75
- group Id
- OG004
- lower Limit
- 11.56
- upper Limit
- 55.11
- value
- 33.33
- group Id
- OG005
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 16
- group Id
- OG004
- value
- 18
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- units
- Participants
- title
- Pediatric Patients
- categories
- measurements
- group Id
- OG000
- lower Limit
- 32.56
- upper Limit
- 100
- value
- 75
- group Id
- OG001
- lower Limit
- 28.95
- upper Limit
- 100
- value
- 66.67
- group Id
- OG002
- lower Limit
- 20.48
- upper Limit
- 93.80
- value
- 57.14
- group Id
- OG003
- lower Limit
- 74.50
- upper Limit
- 98.83
- value
- 86.67
- group Id
- OG004
- lower Limit
- 17.18
- upper Limit
- 54.82
- value
- 36
- group Id
- OG005
- lower Limit
- 0
- upper Limit
- 82.94
- value
- 40
- group Id
- OG006
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 30
- group Id
- OG004
- value
- 25
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 6
- units
- Participants
- title
- Adult Patients
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 46
- group Id
- OG004
- value
- 43
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 6
- units
- Participants
- description
- Participants who experienced Grade 3 or higher toxicity was assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Dose-Finding Level 1 CR: Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2
- id
- OG000
- title
- Dose-Finding Level 1 CR
- description
- Dose-Finding Level 1 RT: Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2
- id
- OG001
- title
- Dose-Finding Level 1 RT
- description
- Dose-Finding Level 2 RT: Adult: Pazopanib 800 mg; Pediatric: Pazopanib 450 mg/m2
- id
- OG002
- title
- Dose-Finding Level 2 RT
- description
- Regimen A: Chemoradiation plus pazopanib
- id
- OG003
- title
- Regimen A
- description
- Regimen B: Chemoradiation alone
- id
- OG004
- title
- Regimen B
- description
- Regimen C: Radiation therapy plus pazopanib
- id
- OG005
- title
- Regimen C
- description
- Regimen D: Radiation therapy alone
- id
- OG006
- title
- Regimen D
- param Type
- NUMBER
- population Description
- Ineligible patients are excluded.
- reporting Status
- POSTED
- time Frame
- Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year
- title
- Percentage of Patients Who Experienced Grade 3 or Higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
- type
- SECONDARY
- unit Of Measure
- Percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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