Phase I Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients With Advanced Malignancies
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01781429 |
Recruitment Status :
Completed
First Posted : February 1, 2013
Results First Posted : March 20, 2020
Last Update Posted : March 20, 2020
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Sponsor:
BioMed Valley Discoveries, Inc
Information provided by (Responsible Party):
BioMed Valley Discoveries, Inc
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Advanced Solid Tumors |
Intervention |
Drug: BVD-523 |
Enrollment | 136 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Dose-escalation 10mg b.i.d. Cohort | Dose-escalation 20mg b.i.d. Cohort | Dose-escalation 40mg b.i.d. Cohort | Dose-escalation 75mg b.i.d. Cohort | Dose-escalation 150mg b.i.d. Cohort | Dose-escalation 300mg b.i.d. Cohort | Dose-escalation 600mg b.i.d. Cohort | Dose-escalation 750mg b.i.d. Cohort | Dose-escalation 900mg b.i.d. Cohort | Cohort-expansion Group 1 | Cohort-expansion Group 2 | Cohort-expansion Group 3 | Cohort-expansion Group 4 | Cohort-expansion Group 5 | Cohort-expansion Group 6 | Cohort-expansion Group 7 |
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Patients received 10mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients received 20mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients received 40mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients received 75mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients received 150mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients received 300mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients received 750mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients received 900mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients with BRAF mutated cancer, except those with colorectal or non-small cell lung cancers, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs. | Patients with BRAF mutated colorectal cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs. | Patients with BRAF mutated melanoma who had progressed or were refractory to BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs. | Patients with NRAS mutated melanoma, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs. | Patients with MEK mutated cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs. | Patients with BRAF mutated non-small cell lung cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs. | Patients with ERK mutated cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs. |
Period Title: Overall Study | ||||||||||||||||
Started | 1 | 1 | 1 | 1 | 1 | 4 | 7 | 4 | 7 | 24 | 18 | 21 | 22 | 8 | 16 | 0 |
Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Not Completed | 1 | 1 | 1 | 1 | 1 | 4 | 7 | 4 | 7 | 24 | 18 | 21 | 22 | 8 | 16 | 0 |
Reason Not Completed | ||||||||||||||||
Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 0 |
Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 1 | 1 | 5 | 2 | 3 | 0 |
Disease Progression | 1 | 0 | 1 | 1 | 1 | 4 | 7 | 4 | 6 | 15 | 15 | 15 | 15 | 4 | 11 | 0 |
Unacceptable Toxicity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
Patient Condition Changed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 1 | 0 | 1 | 0 | 0 |
Other - as entered by PI in eCRF | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 1 | 1 | 1 | 0 |
Enrolled, but not treated | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Dose-escalation 10mg b.i.d. Cohort | Dose-escalation 20mg b.i.d. Cohort | Dose-escalation 40mg b.i.d. Cohort | Dose-escalation 75mg b.i.d. Cohort | Dose-escalation 150mg b.i.d. Cohort | Dose-escalation 300mg b.i.d. Cohort | Dose-escalation 600mg b.i.d. Cohort | Dose-escalation 750mg b.i.d. Cohort | Dose-escalation 900mg b.i.d. Cohort | Cohort-expansion Group 1 | Cohort-expansion Group 2 | Cohort-expansion Group 3 | Cohort-expansion Group 4 | Cohort-expansion Group 5 | Cohort-expansion Group 6 | Total | |
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Patients received 10mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients received 20mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients received 40mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients received 75mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients received 150mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients received 300mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients received 750mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients received 900mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 3 weeks. | Patients with BRAF mutated cancer, except those with colorectal or non-small cell lung cancers, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs. | Patients with BRAF mutated colorectal cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs. | Patients with BRAF mutated melanoma who had progressed or were refractory to BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs. | Patients with NRAS mutated melanoma, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs. | Patients with MEK mutated cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs. | Patients with BRAF mutated non-small cell lung cancer, not previously treated with BRAF and/or MEK inhibitors. Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs. | Total of all reporting groups | |
Overall Number of Baseline Participants | 1 | 1 | 1 | 1 | 1 | 4 | 7 | 4 | 7 | 24 | 17 | 21 | 22 | 8 | 16 | 135 | |
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One patient from Cohort-expansion group 2 was enrolled, but not treated. Therefore, they were not included in the baseline characteristics or study results.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||||||||||
Number Analyzed | 1 participants | 1 participants | 1 participants | 1 participants | 1 participants | 4 participants | 7 participants | 4 participants | 7 participants | 24 participants | 17 participants | 21 participants | 22 participants | 8 participants | 16 participants | 135 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
0 0.0%
|
1 100.0%
|
1 100.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
3 42.9%
|
3 75.0%
|
6 85.7%
|
12 50.0%
|
7 41.2%
|
16 76.2%
|
11 50.0%
|
6 75.0%
|
6 37.5%
|
72 53.3%
|
|
>=65 years |
1 100.0%
|
0 0.0%
|
0 0.0%
|
1 100.0%
|
1 100.0%
|
4 100.0%
|
4 57.1%
|
1 25.0%
|
1 14.3%
|
12 50.0%
|
10 58.8%
|
5 23.8%
|
11 50.0%
|
2 25.0%
|
10 62.5%
|
63 46.7%
|
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||||||||||
Number Analyzed | 1 participants | 1 participants | 1 participants | 1 participants | 1 participants | 4 participants | 7 participants | 4 participants | 7 participants | 24 participants | 17 participants | 21 participants | 22 participants | 8 participants | 16 participants | 135 participants | |
Female |
1 100.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 25.0%
|
5 71.4%
|
1 25.0%
|
5 71.4%
|
8 33.3%
|
7 41.2%
|
9 42.9%
|
5 22.7%
|
1 12.5%
|
9 56.3%
|
52 38.5%
|
|
Male |
0 0.0%
|
1 100.0%
|
1 100.0%
|
1 100.0%
|
1 100.0%
|
3 75.0%
|
2 28.6%
|
3 75.0%
|
2 28.6%
|
16 66.7%
|
10 58.8%
|
12 57.1%
|
17 77.3%
|
7 87.5%
|
7 43.8%
|
83 61.5%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||||||||||
Number Analyzed | 1 participants | 1 participants | 1 participants | 1 participants | 1 participants | 4 participants | 7 participants | 4 participants | 7 participants | 24 participants | 17 participants | 21 participants | 22 participants | 8 participants | 16 participants | 135 participants | |
Hispanic or Latino |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
3 13.6%
|
0 0.0%
|
0 0.0%
|
3 2.2%
|
|
Not Hispanic or Latino |
1 100.0%
|
1 100.0%
|
1 100.0%
|
1 100.0%
|
1 100.0%
|
4 100.0%
|
7 100.0%
|
4 100.0%
|
7 100.0%
|
19 79.2%
|
15 88.2%
|
21 100.0%
|
16 72.7%
|
8 100.0%
|
15 93.8%
|
121 89.6%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
5 20.8%
|
2 11.8%
|
0 0.0%
|
3 13.6%
|
0 0.0%
|
1 6.3%
|
11 8.1%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||||||||||
Number Analyzed | 1 participants | 1 participants | 1 participants | 1 participants | 1 participants | 4 participants | 7 participants | 4 participants | 7 participants | 24 participants | 17 participants | 21 participants | 22 participants | 8 participants | 16 participants | 135 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 14.3%
|
2 8.3%
|
1 5.9%
|
0 0.0%
|
0 0.0%
|
2 25.0%
|
0 0.0%
|
6 4.4%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 25.0%
|
0 0.0%
|
0 0.0%
|
1 14.3%
|
2 8.3%
|
0 0.0%
|
0 0.0%
|
1 4.5%
|
0 0.0%
|
1 6.3%
|
6 4.4%
|
|
White |
1 100.0%
|
1 100.0%
|
1 100.0%
|
1 100.0%
|
1 100.0%
|
3 75.0%
|
7 100.0%
|
4 100.0%
|
5 71.4%
|
19 79.2%
|
15 88.2%
|
20 95.2%
|
18 81.8%
|
6 75.0%
|
15 93.8%
|
117 86.7%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 4.2%
|
1 5.9%
|
1 4.8%
|
3 13.6%
|
0 0.0%
|
0 0.0%
|
6 4.4%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
|||||||||||||||||
United States | Number Analyzed | 1 participants | 1 participants | 1 participants | 1 participants | 1 participants | 4 participants | 7 participants | 4 participants | 7 participants | 24 participants | 17 participants | 21 participants | 22 participants | 8 participants | 16 participants | 135 participants |
1 | 1 | 1 | 1 | 1 | 4 | 7 | 4 | 7 | 24 | 17 | 21 | 22 | 8 | 16 | 135 |
Outcome Measures
Adverse Events