TriangleNCT02130557 · OUTCOME
Number of Participants With Vital Signs Abnormalities
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
- Baseline up to end of treatment (up to Month 60)
What was measured
Criteria for vital signs abnormalities: systolic blood pressure \<80 millimeter of mercury (mmHg), \>210 mmHg; diastolic blood pressure \<40 mmHg, \>130 mmHg; heart rate \<40 beats per minute (bpm), \>150 bpm; temperature \<32 degree celsius, \>40 degree celsius; weight \>=10% increase from baseline, \>=10% decrease from baseline. The number of participants with any vital sign abnormalities during On-treatment period are reported. On-Treatment was defined as values collected after the date of the first dose of test article until the last date of test article +28 days.
Analysis population: Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received. Here, "N" signifies number of participants evaluable for this outcome measure.
Groups in this outcome
Bosutinib
Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
Imatinib
Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
| Group | Source count |
|---|---|
| Bosutinib | 262 |
| Imatinib | 263 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib | 107 | Not reported | Not reported | Not reported | Not reported |
| Imatinib | 109 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 109
- denoms
- counts
- group Id
- OG000
- value
- 262
- group Id
- OG001
- value
- 263
- units
- Participants
- description
- Criteria for vital signs abnormalities: systolic blood pressure \<80 millimeter of mercury (mmHg), \>210 mmHg; diastolic blood pressure \<40 mmHg, \>130 mmHg; heart rate \<40 beats per minute (bpm), \>150 bpm; temperature \<32 degree celsius, \>40 degree celsius; weight \>=10% increase from baseline, \>=10% decrease from baseline. The number of participants with any vital sign abnormalities during On-treatment period are reported. On-Treatment was defined as values collected after the date of the first dose of test article until the last date of test article +28 days.
- groups
- description
- Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
- id
- OG000
- title
- Bosutinib
- description
- Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
- id
- OG001
- title
- Imatinib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received. Here, "N" signifies number of participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline up to end of treatment (up to Month 60)
- title
- Number of Participants With Vital Signs Abnormalities
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice