TriangleNCT03915951 · OUTCOME
Number 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
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From the time the participant provided informed consent, through and including a minimum of 30 calendar days, after the last administration of the study intervention, and the safety follow-up visit (30 days [±7 days] after the EOT visit) (up to 36 months)
What was measured
TEAE was a treatment-emergent adverse event that occurred during the on-treatment period. The on-treatment period was defined as the time from the first dose date of study intervention to the last dose of study drug administration date (when both drugs were permanently discontinued) +30 days or the earliest date of subsequent anti-cancer drug therapy minus 1 day, whichever occurred first. Relatedness to study intervention was determined by the investigator. The investigator made an assessment of intensity for each AE reported during the study according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: Grade 3 events = severe AEs; Grade 4 events = life-threatening consequences, urgent intervention indicated; Grade 5 events = death related to AEs.
Analysis population: Safety Analysis Set included all participants who received at least 1 dose of study intervention.
Groups in this outcome
Treatment-Naive
Treatment-naïve participants with BRAF V600E-mutant metastatic NSCLC were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
Previously Treated
Patients who had received 1) first-line treatment with standard platinum-based chemotherapy, or 2) first-line treatment with an anti-PD-1/PD-L1 inhibitor given alone, or in combination with platinum-based chemotherapy, or in combination with immunotherapy (eg, ipilimumab) with or without platinum-based chemotherapy were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID was to be administered in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
Total
Sum of all participants in the Study C4221008 (ARRAY-818-202)
| Group | Source count |
|---|---|
| Treatment-Naive | 59 |
| Previously Treated | 39 |
| Total | 98 |
Reported measurements
Participants With TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment-Naive | 59 | Not reported | Not reported | Not reported | Not reported |
| Previously Treated | 38 | Not reported | Not reported | Not reported | Not reported |
| Total | 97 | Not reported | Not reported | Not reported | Not reported |
Participants With Treatment-related TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment-Naive | 58 | Not reported | Not reported | Not reported | Not reported |
| Previously Treated | 34 | Not reported | Not reported | Not reported | Not reported |
| Total | 92 | Not reported | Not reported | Not reported | Not reported |
Participants with Maximum Grade 3 or 4 TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment-Naive | 37 | Not reported | Not reported | Not reported | Not reported |
| Previously Treated | 18 | Not reported | Not reported | Not reported | Not reported |
| Total | 55 | Not reported | Not reported | Not reported | Not reported |
Participants with Maximum Treatment-related Grade 3 or 4 TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment-Naive | 27 | Not reported | Not reported | Not reported | Not reported |
| Previously Treated | 13 | Not reported | Not reported | Not reported | Not reported |
| Total | 40 | Not reported | Not reported | Not reported | Not reported |
Participants With Grade 5 TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment-Naive | 5 | Not reported | Not reported | Not reported | Not reported |
| Previously Treated | 7 | Not reported | Not reported | Not reported | Not reported |
| Total | 12 | Not reported | Not reported | Not reported | Not reported |
Participants With Treatment-related Grade 5 TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment-Naive | 1 | Not reported | Not reported | Not reported | Not reported |
| Previously Treated | 0 | Not reported | Not reported | Not reported | Not reported |
| Total | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 97
- title
- Participants With TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 34
- group Id
- OG002
- value
- 92
- title
- Participants With Treatment-related TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 55
- title
- Participants with Maximum Grade 3 or 4 TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 40
- title
- Participants with Maximum Treatment-related Grade 3 or 4 TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 12
- title
- Participants With Grade 5 TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Participants With Treatment-related Grade 5 TEAEs
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 39
- group Id
- OG002
- value
- 98
- units
- Participants
- description
- TEAE was a treatment-emergent adverse event that occurred during the on-treatment period. The on-treatment period was defined as the time from the first dose date of study intervention to the last dose of study drug administration date (when both drugs were permanently discontinued) +30 days or the earliest date of subsequent anti-cancer drug therapy minus 1 day, whichever occurred first. Relatedness to study intervention was determined by the investigator. The investigator made an assessment of intensity for each AE reported during the study according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: Grade 3 events = severe AEs; Grade 4 events = life-threatening consequences, urgent intervention indicated; Grade 5 events = death related to AEs.
- groups
- description
- Treatment-naïve participants with BRAF V600E-mutant metastatic NSCLC were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
- id
- OG000
- title
- Treatment-Naive
- description
- Patients who had received 1) first-line treatment with standard platinum-based chemotherapy, or 2) first-line treatment with an anti-PD-1/PD-L1 inhibitor given alone, or in combination with platinum-based chemotherapy, or in combination with immunotherapy (eg, ipilimumab) with or without platinum-based chemotherapy were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID was to be administered in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
- id
- OG001
- title
- Previously Treated
- description
- Sum of all participants in the Study C4221008 (ARRAY-818-202)
- id
- OG002
- title
- Total
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Analysis Set included all participants who received at least 1 dose of study intervention.
- reporting Status
- POSTED
- time Frame
- From the time the participant provided informed consent, through and including a minimum of 30 calendar days, after the last administration of the study intervention, and the safety follow-up visit (30 days [±7 days] after the EOT visit) (up to 36 months)
- title
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice