TriangleNCT02853331 · OUTCOME
Number of Participants Who Experienced an Adverse Event (AE)
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
- Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
What was measured
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.
Analysis population: The analysis population consisted of all participants who received ≥1 dose of study treatment.
Groups in this outcome
Pembrolizumab + Axitinib
Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
Sunitinib
Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
| Group | Source count |
|---|---|
| Pembrolizumab + Axitinib | 429 |
| Sunitinib | 425 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Axitinib | 422 | Not reported | Not reported | Not reported | Not reported |
| Sunitinib | 423 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 422
- group Id
- OG001
- value
- 423
- denoms
- counts
- group Id
- OG000
- value
- 429
- group Id
- OG001
- value
- 425
- units
- Participants
- description
- An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.
- groups
- description
- Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
- id
- OG000
- title
- Pembrolizumab + Axitinib
- description
- Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
- id
- OG001
- title
- Sunitinib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The analysis population consisted of all participants who received ≥1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
- title
- Number of Participants Who Experienced an Adverse Event (AE)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice