Trial Outcomes & Findings for Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies (NCT NCT03353753)
NCT ID: NCT03353753
Last Updated: 2022-11-21
Results Overview
PFS was defined as the time interval between the date of randomization and the earliest documented evidence of the first disease progression based on the independent radiologic review or death due to any cause on initially assigned study treatment, whichever comes earlier, assessed at 26, 39, and 52 weeks.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
129 participants
Primary outcome timeframe
From date of randomization to the earliest date of disease progression or death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].
Results posted on
2022-11-21
Participant Flow
The first patient enrolled on 27 Feb 2018, with the last patient in (LPI) on 16 Nov 2018. The study is ongoing; Data cutoff date of 31 May 2019. Of the 129 patients enrolled in the double-blind period (ITT population), 85 patients were randomized to the ripretinib arm and 44 patients were randomized to the placebo arm.
Participant milestones
| Measure |
Ripretinib
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Ripretinib vs. Placebo 2:1 ratio
|
Placebo
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Ripretinib vs. Placebo 2:1 ratio
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
44
|
|
Overall Study
COMPLETED
|
46
|
35
|
|
Overall Study
NOT COMPLETED
|
39
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies
Baseline characteristics by cohort
| Measure |
Ripretinib
n=85 Participants
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Ripretinib vs. Placebo 2:1 ratio
|
Placebo
n=44 Participants
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Ripretinib vs. Placebo 2:1 ratio
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age Category (years) · 18 - 64 Years
|
57 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Age, Customized
Age Category (years) · 65 - 74 Years
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Customized
Age Category (years) · 75 Years or Older
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
64 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region
US
|
40 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Region
Non-US
|
45 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Number of Prior Systemic Anticancer Treatments
3
|
54 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Number of Prior Systemic Anticancer Treatments
≥ 4
|
31 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to the earliest date of disease progression or death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].Population: ITT Population
PFS was defined as the time interval between the date of randomization and the earliest documented evidence of the first disease progression based on the independent radiologic review or death due to any cause on initially assigned study treatment, whichever comes earlier, assessed at 26, 39, and 52 weeks.
Outcome measures
| Measure |
Ripretinib
n=85 Participants
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
Placebo
n=44 Participants
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
27.6 Weeks
Interval 20.0 to 29.9
|
4.1 Weeks
Interval 4.0 to 7.3
|
SECONDARY outcome
Timeframe: From date of randomization to the earliest date of disease progression or death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].Population: ITT Population
The percentage of patients with a confirmed complete response or PR (CR: Disappearance of all target lesions and non-target lesions (if present at baseline); all lymph nodes must be non-pathological in size) or partial response (PR: \>=30% decrease in the Sum of Diameters of target lesions and non-target lesions non-PD or NE or none at baseline; or target lesions CR and non-target lesions non-CR/Non-PD or NE) based on the independent radiologic review and during the initially assigned study treatment. To be assigned a status of a CR or PR, changes in tumor measurements must be confirmed by repeat CT or MRI assessments that must be performed at least 4 weeks after the criteria for response are first met.
Outcome measures
| Measure |
Ripretinib
n=85 Participants
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
Placebo
n=44 Participants
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
|---|---|---|
|
Objective Response Rate (ORR)
|
9.4 Percentage of Participants
Interval 4.2 to 17.7
|
0 Percentage of Participants
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: From date of randomization to the earliest date of disease progression [through database cutoff 31-May-2019 (up to approximately 15 months)].Population: ITT Population
TTP is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review.
Outcome measures
| Measure |
Ripretinib
n=85 Participants
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
Placebo
n=44 Participants
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
|---|---|---|
|
Time to Tumor Progression (TTP) Based on Independent Radiologic Review
|
28 Weeks
Interval 20.0 to 36.4
|
4.1 Weeks
Interval 4.0 to 7.6
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].Population: ITT Population
Overall Survival (OS) was defined as the interval between the date of randomization until the date of death or the date of last follow-up.
Outcome measures
| Measure |
Ripretinib
n=85 Participants
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
Placebo
n=44 Participants
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
|---|---|---|
|
Overall Survival (OS)
|
65.6 weeks
Interval 53.6 to 65.6
|
28.6 weeks
Interval 17.9 to 50.4
|
SECONDARY outcome
Timeframe: From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)Population: ITT Population
Changes from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-item - Role Functioning. For the ripretinib arm the minimum and maximum for the outcome were -67 to 67; the placebo arm had a range of -83 to 67. The higher value represents a higher quality of life in disease-related symptoms.
Outcome measures
| Measure |
Ripretinib
n=85 Participants
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
Placebo
n=43 Participants
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
|---|---|---|
|
Quality of Life & Disease-Related Symptoms - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Role Functioning
|
3.5 units on a scale
Standard Deviation 27.31
|
-17.1 units on a scale
Standard Deviation 30.28
|
SECONDARY outcome
Timeframe: From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)Population: ITT Population
Changes from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Physical Functioning. For the ripretinib arm, the minimum and maximum for the outcome were -33 to 53; the placebo arm had a range of -47 to 20. The higher value represents a higher quality of life in disease-related symptoms.
Outcome measures
| Measure |
Ripretinib
n=85 Participants
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
Placebo
n=43 Participants
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
|---|---|---|
|
Quality of Life & Disease-Related Symptoms - Physical Functioning
|
1.6 units on a scale
Standard Deviation 16.03
|
-8.9 units on a scale
Standard Deviation 19.28
|
SECONDARY outcome
Timeframe: From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)Population: ITT Population
Change from baseline in EuroQol Visual Analogue Scale. For the ripretinib arm the minimum and maximum for the outcome were -43 to 91; the placebo arm had a range of -68 to 23. The higher value represents a higher quality of life in disease-related symptoms.
Outcome measures
| Measure |
Ripretinib
n=85 Participants
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
Placebo
n=43 Participants
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
|---|---|---|
|
Quality of Life & Disease-Related Symptoms - EuroQol Visual Analogue Scale
|
3.7 Units on a Scale
Standard Deviation 20.36
|
-8.9 Units on a Scale
Standard Deviation 19.31
|
Adverse Events
Ripretinib
Serious events: 26 serious events
Other events: 84 other events
Deaths: 26 deaths
Placebo
Serious events: 19 serious events
Other events: 42 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Ripretinib
n=85 participants at risk
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
Placebo
n=43 participants at risk
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.5%
3/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.7%
4/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
4.7%
2/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
2/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
2/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
General disorders
Death
|
3.5%
3/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
9.3%
4/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Cardiac disorders
Cardiac Failure
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Cardiac disorders
Pericardial Effusion
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Ascites
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Fecaloma
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Gastrointestinal Fistula
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Hemorrhage
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
0.00%
0/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
General disorders
General Physical Health Deterioration
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
General disorders
Asthenia
|
0.00%
0/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
4.7%
2/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
General disorders
Pyrexia
|
0.00%
0/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.00%
0/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Infections and infestations
Liver Abscess
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Infections and infestations
Sepsis
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
4.7%
2/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Infections and infestations
Urinary Tract Infection
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.00%
0/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Investigations
Blood Bilirubin Increased
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Metabolism and nutrition disorders
Hyperkaliemia
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Metabolism and nutrition disorders
Hypophosphatasemia
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Psychiatric disorders
Hallucinations, mixed
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Psychiatric disorders
Mental Status Changes
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
4.7%
2/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Vascular disorders
Embolism
|
1.2%
1/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
Other adverse events
| Measure |
Ripretinib
n=85 participants at risk
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
Placebo
n=43 participants at risk
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.1%
12/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
18.6%
8/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Nausea
|
38.8%
33/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
11.6%
5/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Abdominal Pain
|
36.5%
31/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
30.2%
13/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Constipation
|
34.1%
29/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
18.6%
8/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Diarrhea
|
28.2%
24/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
14.0%
6/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Vomiting
|
21.2%
18/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
7.0%
3/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Stomatitis
|
10.6%
9/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Abdominal Pain (Upper)
|
9.4%
8/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
4.7%
2/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.2%
7/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
14.0%
6/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
General disorders
Fatigue
|
42.4%
36/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
23.3%
10/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
General disorders
Peripheral Edema
|
16.5%
14/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
7.0%
3/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
General disorders
Asthenia
|
12.9%
11/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
14.0%
6/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
General disorders
Pyrexia
|
7.1%
6/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
4.7%
2/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Investigations
Weight Decreased
|
18.8%
16/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
11.6%
5/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Investigations
Blood Bilirubin Increased
|
16.5%
14/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Investigations
Lipase Increased
|
10.6%
9/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Investigations
Aspartate Aminotransferase Increased
|
7.1%
6/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
4.7%
2/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
7.1%
6/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Investigations
Alanine Aminotransferase Increased
|
5.9%
5/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
27.1%
23/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
20.9%
9/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.6%
9/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.9%
5/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
31.8%
27/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
11.6%
5/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.6%
15/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
4.7%
2/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
15.3%
13/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
4.7%
2/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.4%
8/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
4.7%
2/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
9.4%
8/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
4.7%
2/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.9%
5/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
7.0%
3/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Nervous system disorders
Headache
|
18.8%
16/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
4.7%
2/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Nervous system disorders
Dizziness
|
8.2%
7/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
7.0%
3/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
7.1%
6/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Psychiatric disorders
Insomnia
|
9.4%
8/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
14.0%
6/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Psychiatric disorders
Anxiety
|
8.2%
7/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
9.3%
4/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Psychiatric disorders
Depression
|
7.1%
6/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.9%
11/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
6/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
51.8%
44/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
4.7%
2/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
21.2%
18/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
12.9%
11/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
7.0%
3/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.6%
9/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
4.7%
2/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
5.9%
5/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
5.9%
5/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
5.9%
5/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalized
|
5.9%
5/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
2.3%
1/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
5.9%
5/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
0.00%
0/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
|
Vascular disorders
Hypertension
|
14.1%
12/85 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
4.7%
2/43 • After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Neither Institution nor Investigator will submit for publication or public disclosure any publication or disclosure based on the results of the Study until after the first to occur of (a) publication of the Multi-Center Clinical Trial results; (b) notification by Sponsor that the Multi-Center Clinical Trial submission is no longer planned; or (c) the 12 month anniversary of the completion or early termination of the Multi-Center Clinical Trial.
- Publication restrictions are in place
Restriction type: OTHER