TriangleNCT03261947 · OUTCOME
Percentage of Participants With Grade >=3 TEAEs, SAEs, TEAEs Leading to Dose Modifications, and TEAEs Leading to Treatment Discontinuation in Tumor-Specific Cohorts
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 of the study drug up to 30 days after the last dose (Up to approximately 15 months)
What was measured
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it did not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurred after receiving study drug. TEAEs were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4:Life-threatening consequences, urgent intervention indicated; Grade 5:Death related to AE. An SAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically important due to other reasons than the above mentioned criteria.
Analysis population: Safety Analysis Set included all participants who received any amount of study drug. As pre-specified in the protocol, this outcome measure evaluated and reported data for participants only in the Tumor-Specific Cohorts.
Groups in this outcome
Pancreatic Cancer Cohort
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
Metastatic CRC Cohort
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
sqEC Cohort
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
sqNSCLC Cohort
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
| Group | Source count |
|---|---|
| Pancreatic Cancer Cohort | 15 |
| Metastatic CRC Cohort | 35 |
| sqEC Cohort | 21 |
| sqNSCLC Cohort | 18 |
Reported measurements
Grade >=3 TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pancreatic Cancer Cohort | 73.3 | Not reported | Not reported | Not reported | Not reported |
| Metastatic CRC Cohort | 54.3 | Not reported | Not reported | Not reported | Not reported |
| sqEC Cohort | 57.1 | Not reported | Not reported | Not reported | Not reported |
| sqNSCLC Cohort | 44.4 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pancreatic Cancer Cohort | 40.0 | Not reported | Not reported | Not reported | Not reported |
| Metastatic CRC Cohort | 22.9 | Not reported | Not reported | Not reported | Not reported |
| sqEC Cohort | 23.8 | Not reported | Not reported | Not reported | Not reported |
| sqNSCLC Cohort | 16.7 | Not reported | Not reported | Not reported | Not reported |
TEAEs Leading to Dose Modifications
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pancreatic Cancer Cohort | 53.3 | Not reported | Not reported | Not reported | Not reported |
| Metastatic CRC Cohort | 48.6 | Not reported | Not reported | Not reported | Not reported |
| sqEC Cohort | 52.4 | Not reported | Not reported | Not reported | Not reported |
| sqNSCLC Cohort | 38.9 | Not reported | Not reported | Not reported | Not reported |
TEAEs Leading to Treatment Discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pancreatic Cancer Cohort | 13.3 | Not reported | Not reported | Not reported | Not reported |
| Metastatic CRC Cohort | 8.6 | Not reported | Not reported | Not reported | Not reported |
| sqEC Cohort | 9.5 | Not reported | Not reported | Not reported | Not reported |
| sqNSCLC Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 73.3
- group Id
- OG001
- value
- 54.3
- group Id
- OG002
- value
- 57.1
- group Id
- OG003
- value
- 44.4
- title
- Grade >=3 TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 40.0
- group Id
- OG001
- value
- 22.9
- group Id
- OG002
- value
- 23.8
- group Id
- OG003
- value
- 16.7
- title
- SAEs
- categories
- measurements
- group Id
- OG000
- value
- 53.3
- group Id
- OG001
- value
- 48.6
- group Id
- OG002
- value
- 52.4
- group Id
- OG003
- value
- 38.9
- title
- TEAEs Leading to Dose Modifications
- categories
- measurements
- group Id
- OG000
- value
- 13.3
- group Id
- OG001
- value
- 8.6
- group Id
- OG002
- value
- 9.5
- group Id
- OG003
- value
- 0
- title
- TEAEs Leading to Treatment Discontinuation
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 18
- units
- Participants
- description
- An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it did not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurred after receiving study drug. TEAEs were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4:Life-threatening consequences, urgent intervention indicated; Grade 5:Death related to AE. An SAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically important due to other reasons than the above mentioned criteria.
- groups
- description
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
- id
- OG000
- title
- Pancreatic Cancer Cohort
- description
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
- id
- OG001
- title
- Metastatic CRC Cohort
- description
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
- id
- OG002
- title
- sqEC Cohort
- description
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
- id
- OG003
- title
- sqNSCLC Cohort
- param Type
- NUMBER
- population Description
- Safety Analysis Set included all participants who received any amount of study drug. As pre-specified in the protocol, this outcome measure evaluated and reported data for participants only in the Tumor-Specific Cohorts.
- reporting Status
- POSTED
- time Frame
- From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
- title
- Percentage of Participants With Grade >=3 TEAEs, SAEs, TEAEs Leading to Dose Modifications, and TEAEs Leading to Treatment Discontinuation in Tumor-Specific Cohorts
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice