TriangleNCT00720941 · OUTCOME
Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- events per 30 days
- Interval / dispersion
- Standard Deviation
- Time frame
- From Day 1 up to Week 24
What was measured
Non-study medical visits were defined as the sum of primary care physician visits, nurse practitioner/physician's assistant/nurse visits, and medical or surgical specialist visits. Days hospitalized were defined as the sum of days in the general ward and days in intensive care. The number of telephone consultations and ER visits was assessed via individual questions on the electronic Case Report Form. The endpoint was totaled through Week 24, divided by the number of days on treatment for each participant, then multiplied by 30 days to get the number of visits per 30 days.
Analysis population: Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Only those participants who had non-study medical visits, telephone consultations, days in the hospital, and ER visits were analyzed.
Groups in this outcome
Pazopanib 800 mg
Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg
Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
| Group | Source count |
|---|---|
| Pazopanib 800 mg | 429 |
| Sunitinib 50 mg | 432 |
Reported measurements
Non-Study Medical Visits
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pazopanib 800 mg | 0.726 | 1.472 | Not reported | Not reported | Not reported |
| Sunitinib 50 mg | 0.779 | 1.690 | Not reported | Not reported | Not reported |
Telephone Consultations
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pazopanib 800 mg | 0.279 | 0.718 | Not reported | Not reported | Not reported |
| Sunitinib 50 mg | 0.312 | 0.656 | Not reported | Not reported | Not reported |
Hospital Days
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pazopanib 800 mg | 0.402 | 2.273 | Not reported | Not reported | Not reported |
| Sunitinib 50 mg | 0.562 | 2.187 | Not reported | Not reported | Not reported |
ER Visits
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pazopanib 800 mg | 0.037 | 0.156 | Not reported | Not reported | Not reported |
| Sunitinib 50 mg | 0.067 | 0.195 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.472
- value
- 0.726
- group Id
- OG001
- spread
- 1.690
- value
- 0.779
- title
- Non-Study Medical Visits
- categories
- measurements
- group Id
- OG000
- spread
- 0.718
- value
- 0.279
- group Id
- OG001
- spread
- 0.656
- value
- 0.312
- title
- Telephone Consultations
- categories
- measurements
- group Id
- OG000
- spread
- 2.273
- value
- 0.402
- group Id
- OG001
- spread
- 2.187
- value
- 0.562
- title
- Hospital Days
- categories
- measurements
- group Id
- OG000
- spread
- 0.156
- value
- 0.037
- group Id
- OG001
- spread
- 0.195
- value
- 0.067
- title
- ER Visits
- denoms
- counts
- group Id
- OG000
- value
- 429
- group Id
- OG001
- value
- 432
- units
- Participants
- description
- Non-study medical visits were defined as the sum of primary care physician visits, nurse practitioner/physician's assistant/nurse visits, and medical or surgical specialist visits. Days hospitalized were defined as the sum of days in the general ward and days in intensive care. The number of telephone consultations and ER visits was assessed via individual questions on the electronic Case Report Form. The endpoint was totaled through Week 24, divided by the number of days on treatment for each participant, then multiplied by 30 days to get the number of visits per 30 days.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
- id
- OG000
- title
- Pazopanib 800 mg
- description
- Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
- id
- OG001
- title
- Sunitinib 50 mg
- param Type
- MEAN
- population Description
- Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Only those participants who had non-study medical visits, telephone consultations, days in the hospital, and ER visits were analyzed.
- reporting Status
- POSTED
- time Frame
- From Day 1 up to Week 24
- title
- Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24
- type
- SECONDARY
- unit Of Measure
- events per 30 days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice