TriangleNCT03462719 · OUTCOME
Time to Worsening and Time to Improvement as Measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 2 years 10 months
What was measured
Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). Time to Worsening is defined as time interval (months) from randomization to first observation of deterioration. Worsening is defined as a decrease \>= 3 points (on a 0-52 scale). Time to improvement is defined as the time interval (months) from randomization to the first observation of improvement. Improvement is defined as an increase \>=3 points (on a 0-52 scale).
Analysis population: The ITT analysis set included all randomized participants who were analyzed according to assigned treatment group, regardless of the actual treatment received.
Groups in this outcome
Treatment Arm A (Ibrutinib + Venetoclax)
Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is of 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
Treatment Arm B (Chlorambucil + Obinutuzumab)
Participants received chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight orally once daily on Days 1 and 15 of Cycles 1 to 6 in combination with obinutuzumab 1000 mgs intravenously (IV) once daily on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (each cycle is of 28 days). Participants who subsequently developed IRC-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Treatment Arm A (Ibrutinib + Venetoclax) | 106 |
| Treatment Arm B (Chlorambucil + Obinutuzumab) | 105 |
Reported measurements
Time to Worsening
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Arm A (Ibrutinib + Venetoclax) | 8.15 | Not reported | 3.98 | 10.94 | Not reported |
| Treatment Arm B (Chlorambucil + Obinutuzumab) | 14.03 | Not reported | 8.61 | NA | Here "NA" indicates that upper limit of 95% CI was not estimable due to insufficient number of events. |
Time to Improvement
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Arm A (Ibrutinib + Venetoclax) | 5.59 | Not reported | 3.81 | 11.20 | Not reported |
| Treatment Arm B (Chlorambucil + Obinutuzumab) | 3.75 | Not reported | 2.20 | 5.75 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.98
- upper Limit
- 10.94
- value
- 8.15
- comment
- Here "NA" indicates that upper limit of 95% CI was not estimable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- 8.61
- upper Limit
- NA
- value
- 14.03
- title
- Time to Worsening
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.81
- upper Limit
- 11.20
- value
- 5.59
- group Id
- OG001
- lower Limit
- 2.20
- upper Limit
- 5.75
- value
- 3.75
- title
- Time to Improvement
- denoms
- counts
- group Id
- OG000
- value
- 106
- group Id
- OG001
- value
- 105
- units
- Participants
- description
- Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). Time to Worsening is defined as time interval (months) from randomization to first observation of deterioration. Worsening is defined as a decrease \>= 3 points (on a 0-52 scale). Time to improvement is defined as the time interval (months) from randomization to the first observation of improvement. Improvement is defined as an increase \>=3 points (on a 0-52 scale).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is of 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Treatment Arm A (Ibrutinib + Venetoclax)
- description
- Participants received chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight orally once daily on Days 1 and 15 of Cycles 1 to 6 in combination with obinutuzumab 1000 mgs intravenously (IV) once daily on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (each cycle is of 28 days). Participants who subsequently developed IRC-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Treatment Arm B (Chlorambucil + Obinutuzumab)
- param Type
- MEDIAN
- population Description
- The ITT analysis set included all randomized participants who were analyzed according to assigned treatment group, regardless of the actual treatment received.
- reporting Status
- POSTED
- time Frame
- Up to 2 years 10 months
- title
- Time to Worsening and Time to Improvement as Measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice