TriangleNCT01064310 · OUTCOME
Number of Participants With Grade 1 to Grade 5 Adverse Events (AEs)
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
- Baseline to end of study (maximum of 22 weeks)
What was measured
AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.
Analysis population: Safety-Randomized Study Population
Groups in this outcome
Sunitinib
Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
Pazopanib
Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
| Group | Source count |
|---|---|
| Sunitinib | 148 |
| Pazopanib | 153 |
Reported measurements
Grade 0
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 0 | Not reported | Not reported | Not reported | Not reported |
| Pazopanib | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 20 | Not reported | Not reported | Not reported | Not reported |
| Pazopanib | 25 | Not reported | Not reported | Not reported | Not reported |
Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 57 | Not reported | Not reported | Not reported | Not reported |
| Pazopanib | 63 | Not reported | Not reported | Not reported | Not reported |
Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 58 | Not reported | Not reported | Not reported | Not reported |
| Pazopanib | 51 | Not reported | Not reported | Not reported | Not reported |
Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 11 | Not reported | Not reported | Not reported | Not reported |
| Pazopanib | 8 | Not reported | Not reported | Not reported | Not reported |
Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 1 | Not reported | Not reported | Not reported | Not reported |
| Pazopanib | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 0
- categories
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 25
- title
- Grade 1
- categories
- measurements
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 63
- title
- Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 51
- title
- Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 8
- title
- Grade 4
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Grade 5
- denoms
- counts
- group Id
- OG000
- value
- 148
- group Id
- OG001
- value
- 153
- units
- Participants
- description
- AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.
- groups
- description
- Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
- id
- OG000
- title
- Sunitinib
- description
- Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
- id
- OG001
- title
- Pazopanib
- param Type
- NUMBER
- population Description
- Safety-Randomized Study Population
- reporting Status
- POSTED
- time Frame
- Baseline to end of study (maximum of 22 weeks)
- title
- Number of Participants With Grade 1 to Grade 5 Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice