NCT00720941 · OUTCOME
Number of Participants With Adverse Events
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 study treatment start date till 28 days safety follow-up, assessed up to approximately 152 months
What was measured
The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs), through the monitoring of relevant clinical and laboratory safety parameters.
Analysis population: Safety Population: all randomized participants who received at least one dose of study medication, according to the actual treatment received.
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 | 554 |
| Sunitinib 50 mg | 548 |
Reported measurements
Adverse Events (AEs)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pazopanib 800 mg | 551 | Not reported | Not reported | Not reported | Not reported |
| Sunitinib 50 mg | 535 | Not reported | Not reported | Not reported | Not reported |
Serious Adverse Events (SAEs)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pazopanib 800 mg | 242 | Not reported | Not reported | Not reported | Not reported |
| Sunitinib 50 mg | 227 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 551
- group Id
- OG001
- value
- 535
- title
- Adverse Events (AEs)
- categories
- measurements
- group Id
- OG000
- value
- 242
- group Id
- OG001
- value
- 227
- title
- Serious Adverse Events (SAEs)
- denoms
- counts
- group Id
- OG000
- value
- 554
- group Id
- OG001
- value
- 548
- units
- Participants
- description
- The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs), through the monitoring of relevant clinical and laboratory safety parameters.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population: all randomized participants who received at least one dose of study medication, according to the actual treatment received.
- reporting Status
- POSTED
- time Frame
- From study treatment start date till 28 days safety follow-up, assessed up to approximately 152 months
- title
- Number of Participants With Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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