TriangleNCT01885195 · OUTCOME
Number of Participants With Vital Sign Abnormality of Greater Than or Equal to (>=) Grade 3 as Per CTCAE v4.03
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months)
What was measured
Vital signs included hypertension, hypotension and weight decreased were reported. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated. Participants with grade 3 or higher vital sign abnormality are reported.
Analysis population: Safety analysis set included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline safety assessment.
Groups in this outcome
Binimetinib (MEK162)
Participants received an oral dose of 45 mg of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months.
| Group | Source count |
|---|---|
| Binimetinib (MEK162) | 110 |
Reported measurements
Hypertension
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Binimetinib (MEK162) | 15 | Not reported | Not reported | Not reported | Not reported |
Hypotension
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Binimetinib (MEK162) | 6 | Not reported | Not reported | Not reported | Not reported |
Weight Decreased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Binimetinib (MEK162) | 11 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 15
- title
- Hypertension
- categories
- measurements
- group Id
- OG000
- value
- 6
- title
- Hypotension
- categories
- measurements
- group Id
- OG000
- value
- 11
- title
- Weight Decreased
- denoms
- counts
- group Id
- OG000
- value
- 110
- units
- Participants
- description
- Vital signs included hypertension, hypotension and weight decreased were reported. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated. Participants with grade 3 or higher vital sign abnormality are reported.
- groups
- description
- Participants received an oral dose of 45 mg of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months.
- id
- OG000
- title
- Binimetinib (MEK162)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline safety assessment.
- reporting Status
- POSTED
- time Frame
- From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months)
- title
- Number of Participants With Vital Sign Abnormality of Greater Than or Equal to (>=) Grade 3 as Per CTCAE v4.03
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice