NCT01761266 · OUTCOME
Time to Clinically Meaningful Worsening of HRQoL Assessed Using - EORTC QLQ- Hepatocellular Carcinoma Domain (HCC 18)
A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma · Source last updated 2022-04-05
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
- Baseline up to Off-Treatment Visit (approximately up to 3.8 years)
What was measured
The EORTC QLQ-HCC-18 was an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30. EORTC QLQ-HCC 18 questionnaire included 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. Each individual item ranges from 1 to 4, where 1 = "not at all" and 4 = "very much." All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represented a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represented a high QoL, but a high score for a symptom scale/item represented a high level of symptomatology/problem. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date.
Analysis population: The FAS included all participants who were randomized.
Groups in this outcome
Lenvatinib
Subjects received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (\>=) 60 kilogram (kg) or 8 mg based on the subject's body weight less than (\<) 60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Sorafenib
Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Lenvatinib | 478 |
|---|
| Sorafenib | 476 |
|---|
Reported measurements
Fatigue
Values in months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenvatinib | 1.9 | 1.81 | 1.81 | 1.97 | Not reported |
|---|
| Sorafenib | 1.8 | 1.74 | 1.74 | 1.87 | Not reported |
|---|
Jaundice
Values in months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenvatinib | 4.6 | 3.72 | 3.72 | 5.52 | Not reported |
|---|
| Sorafenib | 3.7 | 2.86 | 2.86 | 4.73 | Not reported |
|---|
Body Image
Values in months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenvatinib | 2.8 | 2.73 | 2.73 | 3.68 | Not reported |
|---|
| Sorafenib | 1.9 | 1.84 | 1.84 | 2.73 | Not reported |
|---|
Nutrition
Values in months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenvatinib | 4.1 | 3.68 | 3.68 | 5.52 | Not reported |
|---|
| Sorafenib | 2.8 | 2.04 | 2.04 | 3.06 | Not reported |
|---|
Pain
Values in months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenvatinib | 2.7 | 1.97 | 1.97 | 2.83 | Not reported |
|---|
| Sorafenib | 2.8 | 2.73 | 2.73 | 3.72 | Not reported |
|---|
Fever
Values in months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenvatinib | 5.5 | 4.57 | 4.57 | 6.51 | Not reported |
|---|
| Sorafenib | 3.7 | 2.99 | 2.99 | 5.52 | Not reported |
|---|
Sex Life
Values in months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenvatinib | 7.4 | 5.46 | 5.46 | 9.17 | Not reported |
|---|
| Sorafenib | 6.7 | 4.60 | 4.60 | 13.78 | Not reported |
|---|
Abdominal swelling
Values in months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lenvatinib | 7.4 | 5.52 | 5.52 | 9.24 | Not reported |
|---|
| Sorafenib | 7.4 | 5.46 | 5.46 | 10.13 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.81
- spread
- 1.81
- upper Limit
- 1.97
- value
- 1.9
- group Id
- OG001
- lower Limit
- 1.74
- spread
- 1.74
- upper Limit
- 1.87
- value
- 1.8
- title
- Fatigue
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.72
- spread
- 3.72
- upper Limit
- 5.52
- value
- 4.6
- group Id
- OG001
- lower Limit
- 2.86
- spread
- 2.86
- upper Limit
- 4.73
- value
- 3.7
- title
- Jaundice
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.73
- spread
- 2.73
- upper Limit
- 3.68
- value
- 2.8
- group Id
- OG001
- lower Limit
- 1.84
- spread
- 1.84
- upper Limit
- 2.73
- value
- 1.9
- title
- Body Image
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.68
- spread
- 3.68
- upper Limit
- 5.52
- value
- 4.1
- group Id
- OG001
- lower Limit
- 2.04
- spread
- 2.04
- upper Limit
- 3.06
- value
- 2.8
- title
- Nutrition
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.97
- spread
- 1.97
- upper Limit
- 2.83
- value
- 2.7
- group Id
- OG001
- lower Limit
- 2.73
- spread
- 2.73
- upper Limit
- 3.72
- value
- 2.8
- title
- Pain
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.57
- spread
- 4.57
- upper Limit
- 6.51
- value
- 5.5
- group Id
- OG001
- lower Limit
- 2.99
- spread
- 2.99
- upper Limit
- 5.52
- value
- 3.7
- title
- Fever
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.46
- spread
- 5.46
- upper Limit
- 9.17
- value
- 7.4
- group Id
- OG001
- lower Limit
- 4.60
- spread
- 4.60
- upper Limit
- 13.78
- value
- 6.7
- title
- Sex Life
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.52
- spread
- 5.52
- upper Limit
- 9.24
- value
- 7.4
- group Id
- OG001
- lower Limit
- 5.46
- spread
- 5.46
- upper Limit
- 10.13
- value
- 7.4
- title
- Abdominal swelling
- denoms
- counts
- group Id
- OG000
- value
- 478
- group Id
- OG001
- value
- 476
- units
- Participants
- description
- The EORTC QLQ-HCC-18 was an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30. EORTC QLQ-HCC 18 questionnaire included 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. Each individual item ranges from 1 to 4, where 1 = "not at all" and 4 = "very much." All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represented a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represented a high QoL, but a high score for a symptom scale/item represented a high level of symptomatology/problem. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Subjects received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (\>=) 60 kilogram (kg) or 8 mg based on the subject's body weight less than (\<) 60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
- id
- OG000
- title
- Lenvatinib
- description
- Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
- id
- OG001
- title
- Sorafenib
- param Type
- MEDIAN
- population Description
- The FAS included all participants who were randomized.
- reporting Status
- POSTED
- time Frame
- Baseline up to Off-Treatment Visit (approximately up to 3.8 years)
- title
- Time to Clinically Meaningful Worsening of HRQoL Assessed Using - EORTC QLQ- Hepatocellular Carcinoma Domain (HCC 18)
- type
- SECONDARY
- unit Of Measure
- months
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