TriangleNCT02737501 · OUTCOME
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose up to 30 days after last dose of study drug (Up to approximately 37 months)
What was measured
An AE is any untoward medical occurrence in a participant. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug (i.e., occurs after the first dose of study drug) is also an AE. TEAEs are defined as AEs starting/worsening on or after the first dose of study treatment and no later than the earliest of 30 days after the last dose of the treatment to which the participant was assigned, or the day before start of brigatinib therapy in crossover participant.
Analysis population: Treated Population included all participant who received at least 1 dose of study drug and served as basis of safety analysis.
Groups in this outcome
Randomized Phase: Brigatinib 90 mg QD/180 QD
Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
Randomized Phase: Crizotinib 250 mg BID
Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
Crossover Phase: Brigatinib 90 mg QD/180 mg QD
Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).
| Group | Source count |
|---|---|
| Randomized Phase: Brigatinib 90 mg QD/180 QD | 136 |
| Randomized Phase: Crizotinib 250 mg BID | 137 |
| Crossover Phase: Brigatinib 90 mg QD/180 mg QD | 65 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomized Phase: Brigatinib 90 mg QD/180 QD | 100 | Not reported | Not reported | Not reported | Not reported |
| Randomized Phase: Crizotinib 250 mg BID | 100 | Not reported | Not reported | Not reported | Not reported |
| Crossover Phase: Brigatinib 90 mg QD/180 mg QD | 98.5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 100
- group Id
- OG001
- value
- 100
- group Id
- OG002
- value
- 98.5
- denoms
- counts
- group Id
- OG000
- value
- 136
- group Id
- OG001
- value
- 137
- group Id
- OG002
- value
- 65
- units
- Participants
- description
- An AE is any untoward medical occurrence in a participant. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug (i.e., occurs after the first dose of study drug) is also an AE. TEAEs are defined as AEs starting/worsening on or after the first dose of study treatment and no later than the earliest of 30 days after the last dose of the treatment to which the participant was assigned, or the day before start of brigatinib therapy in crossover participant.
- groups
- description
- Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
- id
- OG000
- title
- Randomized Phase: Brigatinib 90 mg QD/180 QD
- description
- Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
- id
- OG001
- title
- Randomized Phase: Crizotinib 250 mg BID
- description
- Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).
- id
- OG002
- title
- Crossover Phase: Brigatinib 90 mg QD/180 mg QD
- param Type
- NUMBER
- population Description
- Treated Population included all participant who received at least 1 dose of study drug and served as basis of safety analysis.
- reporting Status
- POSTED
- time Frame
- From first dose up to 30 days after last dose of study drug (Up to approximately 37 months)
- title
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice